Job Specific Responsibilities
- Assist the Clinical Research team with protocol compliance by creating treatment calendars for patients, physicians, and treating department (i.e. MRI or infusion therapy): assisting in scheduling of proper tests and follow-up visits; maintains contact with patient/family and physician to provide continuity of care and follow-up.
- Assists clinical research team to identify and screen potential patients for protocol eligibility; consents patients into clinical trials
- Maintains regulatory files of all clinical research trials.
- Assists in audit preparation and meets with auditors, as appropriate.
- Assists in obtaining, preparing, and submitting reports, forms, applications and other regulatory documents to the IRB to obtain/maintain approval of clinical research trials.
- Assists in the maintenance of investigational drug management in conjunction with pharmacist.
- Assumes project coordinator role specific to individual research grants/projects under the supervision of the Research Supervisor.
- Completes CRFs (electronic/written) and submits within the time requirements of clinical trials
- Coordinates shipping of blood, tissue samples, or pathology slides as required by clinical trial.
- Creates and maintains clinical trial charts which contain copies of all forms and reports submitted for each study subject/participants
- Provides coordinator with needed protocol accrual data.
- Responds to data inquiries when requested.
- Responsible for assisting in developing materials for patient educational purposes as well as educating patients regarding various clinical trials.
- Responsible for reviewing and abstracting medical record clinical data to study Case Report Forms (CRF)
- Schedules patients for research protocol required visits.
- Assists clinical research team in identifying and submitting serious adverse event reports to the IRB/Sponsor in a timely manner.
- Adheres to regulations regarding clinical research with human subjects, including but not limited to FDA, 45 CFR 46, DHS, OHRP.
- Obtains and maintains current knowledge and upkeep of OCT vision machine operations, tests, and test records.
- Obtains and maintains current knowledge and upkeep of GAITRite walkway machine operations, tests, and test records.
- Acquires and maintains competency in performing Multiple Sclerosis Functional Composite, Symbol Digit Modality Test, proficient computer skills to include database management, spreadsheet proficiency, programming, scripting and graphics.
- Bachelor degree or equivalent in business administration, health care administration or related discipline required
- Clinical research experience at least one year or related experience in a medical setting
- Familiar with medical terminology, working knowledge of Microsoft Office (Word, Excel. SPSS a plus)
- Society of Clinical Research Associates (SOCRA) or Association Clinical Research Professional (ACRP) certification preferred
Monday - Friday, 8:00am - 4:30pm
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Equal Opportunity Employer
RWJBarnabas Health is the most comprehensive health care delivery system in New Jersey, with a service area covering five million people. The system includes eleven acute care hospitals Clara Maass Medical Center in Belleville, Community Medical Center in Toms River, Jersey City Medical Center in Jersey City, Monmouth Medical Center in Long Branch, Monmouth Medical Center Southern Campus in Lakewood, Newark Beth Israel Medical Center in Newark, RWJUH- New Brunswick, RWJUH- Somerset in Somerville, RWJUH- Hamilton, RWJUH- Rahway and Saint Barnabas Medical Center in Livingston; three acute care children s hospitals and a leading pediatric rehabilitation hospital (Children s Specialized Hospital), a freestanding 100-bed behavioral health center, trauma centers, a satellite emergency department, ambulatory care centers, geriatric centers, the state s largest behavioral health network, comprehensive home care and hospice programs, fitness and wellness centers, retail pharmacy services, a medical group, multi-site imaging centers and an accountable care organization.
Barnabas Health Medical Group is a multispecialty group practice comprised of highly trained and experienced world class primary and specialty care physicians. Barnabas Health Medical Group physicians provide compassionate and innovative cutting-edge care for people at every stage of life at easily accessible facilities conveniently located throughout New Jersey. Backed by the vast continuum of resources of RWJBarnabas Health, the largest not-for-profit integrated health care delivery system in New Jersey and one of the largest in the nation, our dedicated physicians and expertly trained supporting staff continuously strive for clinical excellence.
We offer a great work environment, competitive rates and excellent benefits, including:
- Medical/Dental/Vision plans
- 401 (k)
- Short & Long Term Disability
- Basic Life & Accidental Death Insurance
- Tuition Reimbursement
- Health Care/Dependent Care Flexible Spending Accounts
Equal Opportunity Employer
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