For full job description and requirements, please visit us online at www.saic-frederick.com and reference Requisition 176408.
Responsibilities
This position provides essential project/program management expertise to support the comprehensive technical work for the Office of Latin American Cancer Development Program initiatives, and is responsible for performing comprehensive project and programmatic planning, research, subcontracting, analysis, communication, and liaison activities.
Requirements
This position will be located in a split position; 3 days/week in Rockville, MD, and 2 days/week in Frederick, MD.
Possession of a Bachelors degree from an accredited college/university in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree.
In addition to educational requirement, a minimum of six (6) years of progressively responsible relevant experience in clinical trials, with the ability to perform project management functions. Bilingual language requirement (English and Latin American Spanish. Portuguese a plus).
Contact
For more information and to apply, please visit www.saic-frederick.com and Reference Requisition 176408,
The AngelMed Guardian® system is an implantable cardiac monitoring and alerting system that is designed to warn cardiac patients of potentially life-threatening heart conditions.
Responsibilities
The Clinical Compliance Manager is responsible for the continued implementation and maintenance of a functional clinical Quality Management System to ensure that the clinical affair’s activities area carried out in accordance with applicable company SOP’s, laws, guidelines and regulations. Act as company liaison for Institutional Review Boards to ensure compliance informed consents. Candidate must be willing to travel.
Requirements
BA/BS degree in biological sciences, nursing or related discipline or equivalent
Minimum of 5 – 10 years experience in the medical device industry or other regulated industry
Four years within clinical research/clinical affairs
Clinical site monitoring experience is required
Previous FDA inspection and/or study site coordinator experience a plus.
This position will be responsible for overseeing the daily activities of Phase 1-3 world-wide clinical trials of drug candidates by ensuring that high quality and valid data supports regulatory applications and approvals of new-marketed products and indications. Responsibilities will include, but will not be limited to: managing Clinical personnel to conduct investigator identification, selection, training and routine monitoring; maintaining and negotiating vendor contracts; managing budgets and payments; serving as the study lead on Clinical project teams; participating in the design and development of clinical study protocols and CRFs across a range of therapeutic areas to ensure monitoring efforts fully complement the drug development process within established timelines; managing and executing trials through a combination of internal and external (CRO) staff.
Requirements
Bachelor's or master's degree in a scientific related discipline
Minimum of eight (8) years of clinical development experience in a pharmaceutical or clinical research organization
Previous Clinical Project Manager experience in conducting and managing Phase 1-3 clinical trials
Experience in conducting Oncology clinical trials
Ability to manage multiple projects across several departments while influencing project decisions in coordination with clinical, regulatory, pre-clinical and CMC timelines
Proficiency with Microsoft Office Suite
Excellent organization and communication skills
Ability and desire to work in a team-oriented environment
This is an excellent part-time (20-30 hours/week) opportunity for an individual to assist Hospice of the Western Reserve's research collaborative in the evaluation and management of the research agenda. The incumbent is responsible for the coordination of all aspects of research clinical trials per study protocol.
Requirements
The individual must have at least two years of experience in clinical research, and phlebotomy skills.
Excellent organizational, interpersonal and communication skills are required, and the individual must be able to manage multiple tasks under limited direction while generating quality deliverables.
Must have a car, valid driver’s license and a good driving record, and SoCRA certification preferred.
Contact
Please email (dlongshaw@hospicewr.org) or send a letter of interest and resume for review to:
Hospice of the Western Reserve,
Human Resources, 300 E. 185th Street,
Cleveland, OH 44119
If you have any questions, please do not hesitate to contact Human Resources at 216.383.6679 or visit our web site at www.hospicewr.org
Musculoskeletal Clinical Regulatory Advisers, LLC
Northeast, USA including: New York, New Jersey, Washington D.C, Pennsylvania, Connecticut, Massachusetts. Ideally we want the person to be commutable to our D.C office.
MCRA, LLC is a highly specialized consulting firm serving the worldwide neuro-musculoskeletal industry. MCRA’s consultants are industry leaders who support Clinical, Regulatory, Quality Assurance, Reimbursement, and Intellectual Property initiatives related to the development and commercialization of various technologies and products.
Responsibilities
Home based Regional Clinical Research Associate (CRA) must have the ability to handle confidential information and comply with the Standard Operation Procedures (SOPs), GCP and HIPAA regulations and have the ability to travel up to 50% of the time.
Requirements
Master’s preferred
3+ years directly related experience
Certified Clinical Professional preferred (SoCRA or ACRP)
Orthopaedics knowledge preferred
Computer proficiency required and experience with EDC systems preferred
Shionogi USA has a strong pipeline of clinical compounds which has resulted in the growth of our clinical team. Shionogi USA offers a competitive compensation and benefits package.
Responsibilities
Coordinate site management; performance and clinical supply issues; monitor study protocol(s); identify and recruit investigators; interface with investigators and study coordinators.
The Bay Area Tumor Institute, a cancer research organization based in Oakland, California seeks a CRA to manage clinical trials for an oncology clinic in Martinez, CA.
Responsibilities
Identify eligible patients
Assist with informed consent
Schedule required tests
Monitor protocol treatment via close collaboration with clinic staff
Simpirica Spine, a venture-backed Bay Area medical device company located in San Carlos, California, seeks a Clinical Research Associate to support all aspects of clinical trials including design, planning and implementation.
Responsibilities
Assist with clinical protocols, CRFs, and site training materials.
Assist with IRB/EC submissions/reports.
Perform site qualifications and monitoring, including source document audits.
Work with study investigators, coordinatorsother study site personnel.
Provide surgical support for clinical case coverage.
Assist in management of CEC, Medical Monitor and DSMB.
Work with CRO’s regarding scope of work and project timelines.
Assist in management of clinical databases and data entry.
Manage clinical study documentation.
Requirements
BS, RN degree or other professional clinical/medical experience a plus.
Minimum 2-4 years relevant clinical research experience.
Excellent organizational, interpersonal, communication skills.
Manage multiple tasks under limited direction while generating quality deliverables.
Clinical Research Associate (Administrative)
Clinical Research Scientist (PhD)
The McConnell Group, Inc.
Naval Medical Center, San Diego, CA
The McConnell Group, Inc., a leading provider of clinical research support services to the Department of Defense, is seeking a Clinical Research Associate (Administrative) and a Clinical Research Scientist (PhD) to support the Naval Lung Injury Research Program at the Naval Medical Center, San Diego, CA. Competitive pay and benefits including: Health insurance; paid holidays, vacation, and PTO; EAP; Education Assistance, and 401(k).
Responsibilities
The project objectives are to investigate the pathophysiology of lung injury with an emphasis on blast lung injury and the prevention and treatment of lung injury.
Requirements
Position details and eligibility requirements can be viewed at www.themccgroup.com on the Career Opportunities page.
Clinical Research Coordinator -Virginia Beach, Full-time position includes enrolling and managing patients, data collection and management, preparation of regulatory and compliance documents.
Requirements
Must be detail oriented.
Cardiology experience preferred.
Contact
Please email resume to marym@cval.org or fax to: 757 213-9363.
MaineGeneral Medical Center, located in central Maine, has a full-time opening available for a Clinical Research Nurse in our state of the art outpatient facility. MaineGeneral has an established clinical research program with the world-renowned Dana-Farber Cancer that gives patients access to newly approved treatments.
Rsponsibilities
This position is responsible for promoting good clinical practices and overall professional management in the conduct of clinical investigations in collaboration with the Principle Investigator, Medical Director, and relevant internal departments and committees. The Research Nurse leads efforts pertaining to clinical assessments of patients on clinical trials.
Requirements
The ideal candidate must have a minimum of 2 years recent clinical research experience. Oncology nursing experience preferred. Eligibility to practice as a Registered Nurse in the State of Maine is required. BSN is required with a Master's degree preferred. Clinical Research Associate/Professional preferred. Experience with databases (Excel/Access) and spreadsheets as well as strong organizational, interpersonal, and communication skills are required to interact effectively with patients, families, and other healthcare providers.
At High Point Regional, you’ll benefit from a culture that brings you closer to your peers, your patients and the support you need to deliver premier care. It’s an environment where our President walks the halls, management has a face, and there’s a team that never leaves your side. You’ll grow as a professional with your colleagues, touch the lives of those in our community, and see the results of what you do each day. It’s your opportunity to experience not only a rewarding career, but one with true meaning.
Join our family of nurses and discover the camaraderie, respect and openness that lead to a whole new level of healthcare.
Rsponsibilities
Coordinate the conduct of clinical drug/device/quality-of-life studies from pre-study planning through successful completion of all patient visits and documentation. Handle all study-related activities in coordinating the patient care aspects of the studies.
Requirements
RN with valid NC nursing license
Three years of healthcare experience and one year of clinical research experience
Oncology experience strongly preferred
Must obtain and pass CRC certification after two years of HPRHS research experience
Knowledge of clinical research data collection and report preparation
Familiar with GCP standards for conducting, recording and reporting clinical trials
We offer a competitive salary and great benefits including tuition reimbursement and free parking.
Rsponsibilities
Anne Arundel Medical Center, located in beautiful Annapolis, MD, seeks a seasoned RN to coordinate and consult on oncology research to include treatment plans, outcomes, patient responses, and drug toxicities. Maintaining all collected information, you will help interpret and analyze results of clinical research and keep statistics current on all projects.
Requirements
To qualify, you must possess:
at least 2 years of clinical research experience and oncology nursing experience
current RN licensure in the state of Maryland
demonstrated ability to implement research projects.
AHA-HealthCare Provider BLS certification.
Contact
To learn more and to apply online, please visit: www.aahs.org or contact Marita Kellers Sr. Nurse Recruiter at mkellers@aahs.org
SAIC-Frederick, Inc.
National Institutes of Health (NIH)
SAIC-Frederick, Inc. has exciting opportunities in support of clinical research conducted by the National Cancer Institute (NCI) and the National Institutes of Allergy and Infectious Diseases (NIAID), both major research components of the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS).
We currently have opportunities for:
Clinical Research Nurse II #177582
Clinical Research Nurse II #177695
Protocol Nurse Coordinator I #178591
Protocol Nurse Coordinator II #178598
Contact
To learn more about these opportunities and to apply, visit us on-line at www.saic-frederick.com. For more information call 301-846-5361. We value cultural diversity in the workplace.
Mountain States Health Alliance (MSHA) is integrated both vertically and horizontally and is the largest regional healthcare system with 14 hospitals, 10,000 employees, and approximately $1 billion in net revenues. The MSHA Corporate Department of Research was created three years ago and currently has 18 clinical trials.
Responsibilities
The Corporate Director, Department of Research reports to the Chief Medical Officer of Mountain States Health Alliance. The Director will promote, expand and manage research efforts within MSHA. He/She will guide the development of MSHA’s strategic research goals and will assist MSHA in achieving quality recognition and accreditation. This Director will be very visible within the system and will help promote the MSHA Corporate Department of Research and create a high awareness level for the Department.
Requirements
The selected candidate will possess a Masters degree in an appropriate clinical discipline and a minimum of three years of experience, including supervisory experience and experience with the research process. Ideally, the selected candidate will possess at least three years of experience as a Director of Research at a hospital or healthcare system.
Simpirica Spine, a venture-backed medical device company in San Carlos, California, is seeking a Director, Clinical Research for the execution of clinical trials from inception to completion.
Responsibilities
Act as project manager for clinical studies.
Support data analysis and protocol development.
Manage external vendors and clinical site operations in execution of clinical trials.
Manage study investigators, coordinatorsother study site personnel to initiatesupport clinical studies.
Prepare clinical data for FDA filings, publication and other activities requiring clinical data.
Monitor data and study documentation to ensure data integrity and quality.
Requirements
BS in life sciences, RN degree or other professional clinical/medical experience a plus.
Ten years experience in regulatory medical products industry, including 5 years with relevant medical device trials.
Working knowledge of FDA QSR, ISO 13485, MDD regulations.
Director, Clinical Trials Unit for the Ireland Cancer Center of the Case C
University Hospitals Case Medical Center
Our world-renowned health care network is anchored by our flagship facility, University Hospitals Case Medical Center. Located in Cleveland's historic University Circle, this 947-bed academic medical center and tertiary-care hospital is ranked by U.S. News and World Report as one of America's best hospitals in 13 medical and surgical specialties. It comprises three centers of excellence: Ireland Cancer Center, MacDonald Women's Hospital, and Rainbow Babies & Children's Hospital; and The Center for Clinical Research, the largest medical research center in Ohio.
Responsibilities
Provides operational leadership and effective management for the ICC Clinical Trials Unit, 7 community-based ICC sites and coordination of consortia activities involving the Case Comprehensive Cancer Center Develops operating procedures to ensure efficiency and quality Assures compliance with GCP, human subjects protection, and all regulatory agencies Provides quality control and timely, accurate data submission.
Works to address quality improvement opportunities Incorporates a patient and family centered approach that consciously incorporates/includes the patient and family's perspective and focuses on needs as they define them.
Accountable for professional development and growth for staff Develop and implement strategies to continuously improve employee engagement Responsible for appropriate staffing and skill to adequately administer the CTU Core functions.
Team consists of financial, regulatory, clinical, QA/QC Works to manage expenses and promote new revenue or business growth opportunities Collaborates closely with the CTU Medical Director and the Director of the Case Comprehensive Cancer Center to effect the ultimate success of clinical research program.
Requirements
Minimum ten years experience in clinical research environment. Five years management experience. Demonstrated program development and budget management skills.
Prior knowledge of federal, FDA and NCI requirements regarding research involving human subjects. Excellent verbal and written communication skills.
Excellent personnel management skills. Proven ability to manage large clinical research program consisting of phase I through phase IV clinical trials Knowledge of GCPs, Federal Code of Regulations and ICH
Educational Requirements:
Undergraduate Degree required
Masters Degree or Ph.D. preferred
License Requirements:
SoCRA or Research Specific Certification Education in the rights of humans participating in research
University Hospitals is proud to be an equal opportunity employer
Saint Anthony Memorial, voted a technologically-advanced health care system, is a community care facility located by Lake Michigan in Northwest Indiana just 45 miles southeast of Chicago. Join our team in Michigan City, IN in the following career opportunity.
Join our team of exceptional people providing exceptional care! In return for your expertise and dedication, we offer a competitive salary and benefits package along with an excellent work environment.
Responsibilities
Manage the overall daily Phase I (unit) operations within our Clinical Research Center. This will encompass the oversight of study conduct, management of clinic staff and meeting Sponsor objectives. Working with hospital staff as well as with outside vendors and clients will be involved as needed.
Requirements
A Master's degree is preferred in a scientific discipline or equivalent related work experience to encompass 8-10 years staff management experience and 5-10 years clinical research experience (preferably as a Clinical Manager or equivalent).
2+ years in Phase I CRO operations preferred.
Budgeting experience; PC proficiency (Excel & Word); demonstrated organizational skills; GCP training; and knowledge of ICH & FDA regulations pertaining to Phase I activities required.
Spartanburg Regional Healthcare System is an integrated healthcare delivery system anchored by Spartanburg Regional Medical Center, a 540-bed teaching and research hospital. The system offers a range of specialized healthcare services that is unrivaled in its five-county service region, featuring world-class specialty centers making SRHS the region's preferred provider of comprehensive healthcare services.
Responsibilities
Spartanburg Regional has an exciting opportunity for a Federal State and Regulatory Project Manager. The project manager will provide administrative planning for large IT stimulus and research initiatives for multiple projects including coordinating external and internal activities. They will also manage the IT requirements associated with HSSC and the NCCCP project.
Requirements
The successful candidate must have a Bachelors Degree and 8+ years clinical or hospital experience. Masters, managerial and a strong research background are all preferred.
Contact
If you are interested in joining an award winning hospital, please forward curriculum vitae to Hospital Recruiter Kristin Baker, kbaker@srhs.com or 800-288-7762. You may also visit our website at www.spartanburgregional.com
JW Friday Hooker & Associates has been exclusively retained by Columbus Regional Healthcare System to recruit a Manager, Clinical Research for the John B. Amos Cancer Center.
Requirements
BSN required with 5+ years of oncology clinical research experience within a hospital based cancer center/program.
Competitive pay; health insurance; paid holidays and PTO; Education Assistance, 401(k) and College Savings Plan.
Responsibilities
The McConnell Group, Inc., www.themccgroup.com, a leading provider of clinical research support services to the Department of Defense, is seeking a Physical Therapist for a clinical research project utilizing a Computer Assisted Rehabilitation Environment (CAREN) virtual reality system at the Naval Health Research Center in San Diego, CA.
Requirements
Graduate of an accredited Physical Therapy Program
Min. three years’ experience in clinical research, gait laboratories, orthopedics, and motion analysis
Current professional licensure in the State of California
Proficient in computer operations
Knowledge of MATLAB, EVART, NEXUS and/or Visual3D a plus
Must be a U.S. Citizen and pass a security (NAC) clearance, drug/alcohol screen and pre-employment physical
Competitive pay; health insurance; paid holidays and PTO; Education Assistance, 401(k) and College Savings Plan.
Responsibilities
The McConnell Group, Inc., www.themccgroup.com, a leading provider of clinical research support services to the Department of Defense, is seeking experienced Program Managers and Nurses to provide support on clinical research projects at the U.S. Army Institute of Surgical Research in San Antonio, TX.
Requirements
Bachelors degree in area of specialty
Min. five years’ clinical research experience
Current professional certifications / licenses
Understanding of research methodologies, the military acquisition system, personal computer (PC) and office automation operations
Must be a U.S. Citizen and pass a security (NAC) clearance, drug/alcohol screen and pre-employment physical
The principal goal of the TIMI Study Group has been to conduct high quality clinical trials that enhance the care of patients with coronary artery disease. TIMI has been involved in a wide array of phase 1 to phase 4 trials as well as registries. These have ranged in size from less than 30 to more than 300,000 subjects worldwide.
Responsibilities
Accountable for all aspects of project management and administration of large, multi-center, national and international clinical trials. Will oversee the start-up, and daily operations of all assigned ongoing clinical trials. Responsible for meeting all deadlines and the complicated reporting requirements of the various sponsors, including serious adverse event reporting, and for ensuring all regulatory requirements are met.
Requirements
Minimum of Bachelor’s degree and experience in a health/research related field.
Minimum of five years progressively responsible experience in managing all aspects of large, multi-center clinical trials.
Experience with computers and data management systems.
Project Coordinator, Clinical Research in Oncology
M.D. Anderson Cancer Center
Orlando, FL
M.D. Anderson Cancer Center Orlando, a part of Orlando Health, is expanding to meet the growing needs of the community. We are currently seeking a Project Coordinator, Clinical Research in Oncology.
Responsibilities
This position coordinates all protocol regulatory activities.
Requirements
We are seeking candidates with an Associate’s degree in health or research-related field with four years of experience in research; OR a Bachelor’s degree in health or research-related field with two years of experience in research (i.e. healthcare, science, law, regulations, education, statistics, biology).
Experienced Clinical Researchers for PTSD Clinical Trials
As one of the nation’s most respected healthcare providers, NYU Langone Medical Center looks for ambitious professionals who can help us continually improve our performance. Currently, we have an excellent opportunity available for Experienced Clinical Researchers for PTSD Clinical Trials. If you’re ready to make a big impact on both our future and yours, learn more about these opportunities today. We offer a competitive compensation package and a stimulating work environment.
PTSD Clinical Trial Project Manager
The Department of Psychiatry is seeking a Project Manager to implement and manage several research studies of PTSD. Candidate will be responsible for designing and implementing the study methods and monitoring the daily operations of study implementation at multi clinical sites; developing, recruiting, and training a staff of research assistants, diagnostic evaluators and research psychotherapists; preparing and submitting all IRB materials; overseeing and reviewing data management and transmission; conducting structured clinical diagnostic assessments and neuro-cognitive texting; participating in grant and manuscript preparation; plus all related job functions.
Qualifications:
PhD or PsyD in Clinical Psychology with 2+years of Project Management experience in PTSD clinical trials required
Prefer two (2) years postdoctoral research experience including experience in coordinating multi-site clinical research studies required
Knowledge in diagnosis and treatment of Acute and Post-traumatic Stress Disorders (SCID. ARTAT) plus knowledge of Word, Access, Excel, and SPSS required
Clinical PhD- PTSD-Research Scientist:
The Department of Psychiatry is seeking a Clinical Research Scientist for large program PTSD studies. Candidate will be responsible for conducting structured psychodiagnostic interviews with male and female adults with PTSD symptoms. Responsibilities include recruitment of participants, following necessary protocols for study participation, administering assessments including SCID, CAPS and nuerocognitive testing, anxiety reduction intervention, all other duties as it relates to clinical trial implementation.
Qualifications:
Ph.D., Psy.D in Clinical Psychology, Counseling Psychology or related field
1-2 years previous experience in structured diagnostic interviewing
Knowledge in DSM-IV diagnoses is required
Experience in PTSD assessment and diagnosis
Excellent written and oral communication skills
Must have experience working with Veterans and PTSD research
Contact
For further information and to apply, please send your resume and a comprehensive cover letter indicating salary requirements via e-mail: Christopher.McBride@nyumc.org or fax: 212-404-3888. You also may apply online at www.apply.nyumc.org. We are an equal opportunity employer.
Join our innovative team of experienced professionals in one of Boston’s Best Places to Work. We offer a competitive salary/benefits package.
Responsibilities
The Registry Manager is responsible for ensuring efficient and complete collection of patient- and clinician-reported health data using a Web-based system called Integrated Survey System™ (ISS).
S/he will launch surveys for patients using tablet computers, run reports to track compliance, review pending surveys, display aggregate outcomes and design and monitor patient flow process to efficiently collect data from patients.
The Registry Manager will coordinate registry activities, monitor compliance with Federal regulations regarding data registries, maintain effective working relationships with a variety of personnel who interface with the Registry, both within and outside the institution; this includes patients, nurses, physicians and sponsors.
Requirements
Requirements include: using Web-based tools, excellent organizational and communication skills and ability to multi-task. Graduate of an accredited college or university with an Associates degree; Bachelor’s degree preferred. Database management experience preferred.
Contact
To learn more about New England Baptist Hospital and to join our team, please go to www.nebh.org.
New England Baptist Hospital is an Equal Opportunity Employer.
The Vanderbilt-Ingram Cancer Center (VICC) brings together the clinical oncology programs as well as the cancer-related research, education and outreach activities of hundreds of scientists, doctors, nurses and others at Vanderbilt University and Medical Center. It is the only National Cancer Institute-designated Comprehensive Cancer Center in Tennessee that conducts basic, translational and clinical research and offers adult and pediatric oncology treatment. VICC is a member of the National Comprehensive Cancer Network, a non-profit alliance of 21 leading centers working together to improve quality and effectiveness of cancer care.
We are currently seeking qualified candidates for the following positions:
Research Nurse Specialist I – VICC CTSR (Req. # KA18766)
This position requires Graduate of an accredited discipline specific program. Experience with Malignant HEME and Transplant Clinical Trials Patients is preferred. Current Tennessee RN license is required.
Research Nurse Specialist II - VICC CTSR (Req. # KA22485)
This position requires Graduate of an accredited discipline specific program with 1 year of experience. HEME/BMT experience is strongly preferred. Current Tennessee RN license is required.
Both are full-time positions; 40 hours per week; Monday-Friday 8:00am - 5:00pm.
Vanderbilt is a smoke-free workplace in compliance with the Non-Smoker Protection Act, Tennessee Code Annotated 39-17-1801-1810. In accordance with that law and Vanderbilt policy, smoking is prohibited in all enclosed areas on Vanderbilt property.
Background screens will be performed and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
Contact
To learn more about this exciting opportunity and to apply, visit www.vanderbilt.jobs and enter appropriate req. number.
AqueSys is a start-up medical device company located in Southern California (Orange County) developing a proprietary surgical device for the treatment of glaucoma. Glaucoma is the second leading cause of blindness worldwide and affects up to 65 million people.
Responsibilities
We are seeking a high energy, high caliber experienced Senior CRA to support the company's clinical trials. An exciting opportunity for anyone!
Support the smooth operation of domestic and international clinical trials by monitoring case report forms for completeness, legibility and conformity to applicable regulations and SOPs
Monitor site compliance with clinical protocol and reporting deviations and violations
Develop study documents, including and not limited to, clinical protocols, informed consent forms, and case report forms
Interpret clinical data and evaluate deviations
Track the progress of study enrollment and treatments
Ensure the accuracy and completeness of site regulatory documentation including device accountability records; ethic committee approvals and reports, and adverse event documentation
Conduct site initiation, monitoring and close out visits.
Requirements
3 years minimum experience in medical device clinical trials
Ophthalmology experience desirable
Bachelor's Degree
Understanding of and ability to apply basic bio-statistical principles
Chicago (Midwest); Florida (Southeast); Texas; Nevada, Arizona or California (Southwest)
Compensation: Full-time, Permanent, Salaried, Competitive Salary and Benefits
Responsibilities
Participate in the site management and monitoring clinical trials. Ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. Familiar with a variety of the GCP concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. A wide degree of creativity and independence expected.
Requirements
Therapeutic Expertise: HIV/Infectious Disease or Cardiovascular, Medical Device
5 years of relevant pharmaceutical and clinical research experience; requires medical training as a RN or NP; preferred medical degree with a BSN, MSN, DNP degree; must be highly literate and comfortable with the Internet, EDC systems, and MS Office applications; certification by ACRP or SOCRA desired; must be willing to travel up to 70% within region. Must be willing to undergo a Professional, Academic, Financial and Criminal background check.
At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. Abbott offers a comprehensive salary and benefit package. Abbott provides a "smoke-free" work environment.
Responsibilities
Plan and manage multiple or complex/partnership cost center or clinical development program(s). Represent clinical development function at advisories, interactions with regulatory agencies and for evaluating business opportunities, including due diligence.
Requirements
Must have 10+ years of direct clinical research experience, 6+ years of clinical research management, and Investigational Device Exemptions clinical experience. Management experience in clinical operations positions and global experience desirable. 30-50% travel, including international.
DHMC, located in Lebanon, NH is New Hampshire’s only integrated, academic, Level I trauma center. Home to the prestigious Ivy League Dartmouth College, the Lebanon/Hanover area is a vibrant, academic and professional community offering excellent schools, lively arts, and an unmatched quality of life in a beautiful, rural setting.
Responsibilities
The Manager will assist with the development and oversight of the administration and maintenance of regional clinical research operations for the Dartmouth-Hitchcock (D-H) Clinical Trials Office. Additionally, the Manager will promote and facilitate the conduct of clinical research at regional sites of D-H in compliance with regulations, institutional guidelines, and standard operating procedures. The Manager will also develop and maintain the regional CTO operation, serve as an institutional resource to provide high quality clinical trials performed at D-H regional sites and obtain valid data per GCP (Good Clinical Practice).
Requirements
Requirements include a Bachelor’s degree with a minimum of 5 years of experience in the field of clinical research with expertise in Federal, State and Local laws and regulations governing clinical research. A Master’s Degree and professional certification in clinical research is also preferred.
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