ClinicalRM is seeking a Compliance Officer to work at NMCP in Portsmouth, VA.
Audits research investigator activities on site.
Reviews IRB approved protocols and interviews investigators to assure compliance is met.
Reviews data collection forms, verifies entries by validating accurate source documentation, and reviews data security and protection of Protected Health Information (PHI) and Personally Identifiable Information (PII).
Inspects regulatory binders.
Observe recruiting procedures and materials used.
Observe consenting procedures, and review informed consent forms for completeness and security of signed forms is maintained.
Prepares audit reports and follow-up letters of the findings to the PI and CID.
May perform Investigational Drug Accountability. When research that involves an Investigational New Drug (IND), it must follow FDA rules. The FDA requires that the NMCP Pharmacy be in control of IND drugs. "Control" can mean the Pharmacy keeps the drugs or it can mean the Investigator keeps the drugs in a manner acceptable to the Pharmacy. The term Investigational Drug refers to these special IND drugs. The compliance officer may be required to check to see that both the investigator and the Pharmacy are accountable for these drugs.
May participate in the study development process by reviewing protocols, designing and/or reviewing Case Report Forms (CRFs), and developing study documents.
May participate in training programs for research investigators and research support personnel to maintain awareness of developments in the field of clinical research.
Will periodically review IRB procedures. May attend IRB meetings, review membership rosters, appointment letters, research ethics training, meeting minutes, compliance with IRB SOP. Reports will be provided to Head, Research Subject Protection Department (RSPD) and IRB Chairs.
Under the CID administrative duties, may audit research protocol files held by CID ensuring that files are complete, accurate and up to date.
May assist in preparing protocol folders for 2 nd level review for submission to BUMED.
When required, will oversee the query resolution processes.
Will review regulatory documents as required. Will facilitate effective communication between the PI and the Clinical Investigation Department.
Will assist in preparation and response to Federal regulatory audits.
Will attend training, conferences and other meetings as required.
Will work off-site as required.
Will mentor and teach new members of the research support staff, assist in the preparation of project communications and tools, and share ideas and suggestions with staff members.
In regards to Research Integrity, may assist NMCP Research Integrity program with administrative duties and ethics training compliance.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
Perform light duties and other related duties as required and assigned.
BS/BA is preferred in life sciences or a Registered Nurse.
A minimum of three years of monitoring experience.
Have a sound knowledge of medical terminology and clinical monitoring process, and possess in depth therapeutic and protocol knowledge.
Ability to communicate effectively, both orally and in writing.
Possess effective organizational and analytical skills.
Ability to work independently and in a team environment.
Proficient with Windows based computer systems including Microsoft Office.
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.