Ground breaking science. Advancing medicine. Healing made personal.
The Clinical Research Coordinator II (CRC) at the Alzheimer’s Disease Research Center manages clinical studies sponsored by the NIH and industry that explore treatment for older adult patient with Alzheimer’s disease and other memory-related diseases. It is the CRC’s responsibility to assist Principal Investigator in program operations and start up, budget negotiation, oversee budget signatory administrative elements, oversee collection of data under PI supervision including performance of study visit tasks, manage all regulatory folders and FDA requirements, report to the IRB, and collaborate with outside vendors to ensure the safety of the patients and accuracy of data reporting. S/he is the main point of contact for all patients in the ADRC and must possess excellent communication and follow-up skills, respect patient privacy, and possess minimum office / professional skills to collect, record, and utilize data in these trials.
Duties and Responsibilities:
- Assist the Principal Investigator in the conduct of clinical trials and studies including preparing IRB/GCO submissions, regulatory filing, psychometric testing, collecting data and laboratory specimen, recruiting patients, reporting Adverse Events and Serious Adverse Events.
- Accountable for management of case report forms and subject and regulatory binders for industry / sponsor / IRB audits, administer neuropsychological battery of cognitive test for NIH-mandated initiative.
- Obtain informed consent under supervision of Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests, independently obtain informed consent for other clinical studies.
- Screen and coordinate; including documentation of the consent process, and scheduling of subjects and necessary personnel and administration of all patient visits.
- Chart data entry and query resolution as requested by Research Supervisor and PIs for various clinical trials and studies.
- Prepare and present research charts for consensus diagnosis and enter findings into National Uniform Data Systems.
- Assistance on ALL center studies and trials (i.e. knowledge of all studies in order to assist with referrals and coverage to various projects conducted within the center).
- Performs other related duties.
- BS or BA with 2 or more years experience
- 2 years in research environment preferred
- Computer and General Skills:
- Advanced MS Office (Word, Excel, Access, Outlook)
- Excellent written and oral communication skills
- Excellent teaching skills
- Exceptional attention to detail and accuracy
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