CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator)
4 Year Degree
Collaborates with management to identify sites for audits. Schedules and performs audit visits.
Maintains current knowledge of FDA guidelines/OPRP guidelines, regulatory requirements, ICH guidelines, GCP guidelines, and issues relating to research.
Maintains current knowledge of BRANY IRB and QA SOP’s.
Obtains and maintains certification - SOCRA or ACRP(CCRC or CCRA)
Ensures investigative sites are conducting study in accordance with FDA, ICH, GCP and BRANY SOP’s/guidelines. Prepares reports and follows up on corrective action.
Assists sites in preparation for sponsor audits or Federal Inspections as needed.
Conducts site evaluation calls to ensure qualifications of the investigator, staffing and facility.
As an Independent Monitor (IM), oversees the review of regulatory documents, verification of subject eligibility and drug or device dispensing.
Reviews protocol with investigative site(s) and instructs study staff in protocol specific procedures.
Communicates regularly with site regarding study progress and provides support as needed.
Reviews CRF’s for completion and verifies validity with appropriate source documentation.
Utilize custom BRANY software.
Utilize Microsoft Word, Excel, Outlook, and Internet Explorer.
Train and develop new or inexperienced BRANY staff.
Assist Department in other activities as needed. (*)
Use communication skills to establish and maintain good working relationships with site liaisons, investigators, and sponsors.
Use writing skills to effectively communicate via email and written correspondence.
Work independently, take initiative and troubleshoots daily routine problems as they occur. Develop or recommend a plan of corrective action for complex non-routine issues.
Work as a team member on special nonrecurring and ongoing projects. (*)
Travel to research sites is required.
Experience, skills, credential/licenses:
Knowledge of FDA, OHRP, ICH and GCP regulations and guidelines regarding Human Subjects research
ACRP/SOCRA Certification preferred
Organized and detail oriented
Minimum of two years clinical compliance auditing experience or other research related experience
Microsoft Office at the intermediate level or above
Strong writing and communication skills
Telecommuting is allowed.
The Biomedical Research Alliance of New York (BRANY) is a national organization providing support services to sponsors and investigators involved in research in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials. Staffed by multi-disciplinary experts, BRANY is an expedited "end-to-end solution" for clinical trials.
BRANY was founded in 1998 by nationally-ranked academic medical centers, which today includes: NYU School of Medicine, Montefiore Medical Center, Mount Sinai School of Medicine, and North Shore-Long Island Jewish Health System.