Research Regulatory Consultant

* Field of Study:
Biological sciences, Administration, or related field
* OR Associate's Degree with 3 to 4 years clinical research experience
* Years of experience: 2 years of experience in hospital/clinical or administrative setting.
** SPECIALIZED KNOWLEDGE
** Field of Study:
Biological science, Administration or related field or an Field of Study: a related field, 3
-4 years of clinical research Experience and possess Certification as a clinical research coordinator (e. g., ACRP or SoCRA) or currently eligible to obtain the Certification. Medical terminology, proficiency in database, spreadsheet and word processing software. 4 years Experience in hospital/clinical setting, work

Experience with physician contact.
** DESIRED ATTRIBUTES
** Certified clinical research coordinator (e. g., ACRP, SoCRA) knowledge of federal regulations on human subject research, IRB regulations 1-2 years in research setting, experience with budgeting
** RESPONSIBILITIES AND DUTIES
** 30%
Project coordination works with research nurses and physicians to implement study procedures; consult with principal investigator in project decision-making; assigns work to project staff; orients and instructs investigators and staff on data collection and project record-keeping procedures... Ensures investigators have undergone RMH-required education on research regulations. Maintains and stores confidential data collection forms, proposals and final reports in accordance with the hospitals research policies...

Acts as a Liaison with the trial sponsor during the regulatory submission process, collects, organizes, logs, files and transmits all required site & investigator documents. Initiates new research protocol regulatory files in compliance with department SOPs and the Federal Code of Regulations. Acts as a resource to clinical research staff on research regulatory concerns. May be asked to internally audit projects to ensures studies are conducted in accordance with federal regulations related to human subjects research.

Prepares, maintains and updates computerized database pertaining to research patients. May assist in coordinating accounts payable/receivable for clinical trials involving pharmaceutical companies and consortiums. May act as liaison between accounting and finance.
20%
Project Planning facilitates multidisciplinary research team; assesses feasibility of research projects; designs data collection processes. Reviews project proposals for completeness and appropriate formatting. Conducts initial review and dissemination of research protocols, protocol revisions, protocol amendments and obtains opinions from others, when appropriate.
50%
Liaison with Institutional Review Board on ethical matters regarding hospital-sponsored human subjects research; responds to IRB correspondence and determination letters. Prepare proposals applications and submissions to the appropriate institutional review board... Responds to requests for information which originate from other hospital departments, investigators and outside sponsors concerning status of IRB approval.