Full Job Description
Job Summary
Under the direction of the System Executive Director, DMC Clinical Research Office has the primary responsibility of reviewing, evaluating and auditing clinical research studies submitted for DMC Research Review. Conducts billing coverage analyses on clinical studies and consults with principal investigators and research coordinators on the appropriate wording in patient consent forms, study agreements, and protocols in order to mitigate billing risk.
Coordinates and designs processes to ensure compliance to protocol and quality data acquisition, including but not limited to procedures for subject enrollment and registration for DMC clinical services. Coordinates with DMC hospitals' registration, coding, accounting, finance, billing to assure research revenue cycle is compliant. Prepares reports for VHS compliance and Internal Auditing. Provides support to investigators, physicians and fellows in compliant study protocol development, regulatory documentation, and protocol procedures.
Provides DMC research charge information for investigators' study budgets in compliance with NIH guidelines. Works with investigators and industry sponsors to accurately capture all billable events to be covered by the sponsor. Collaborates with accounting and finance to assure accurate invoicing and billing. Oversees study procedures and maintains study documentation in accordance with established Good Clinical Practice (GCP) guidelines, Code of Federal Regulations (CFR) Title 21-regulations, and applicable statute(s).
Assures IRB approval is obtained prior to initiation of studies. In collaboration with study investigator(s) and in a manner consistent with the Declaration of Helsinki and Health Insurance Portability and Accountability Act (HIPAA), assures the protection of the patient's rights and safety. Reports adverse events according to IRB, Sponsor, and FDA guidelines. Collaborates with the IRB of record on overseeing research integrity and patient safety issues. May facilitate external monitoring and auditing of research activities.
As assigned, interviews, schedules, orients, and trains research coordinators and ancillary staff. Reviews clinical site agreements (contracts) and acts as liaison between involved parties. Ensure that charges for study-related care and subject stipends are properly documented and charged to study guarantor accounts. Responsible for maintaining awareness of new regulatory issues and identifies new research activities. Provides support to supplementary projects that advance the goals of the department and the institution's mission, vision, and values.
Qualifications:
1. BS/BA Degree.
2. Minimum of five years experience as a research coordinator or administrator.
3. Four years of progressively more responsible project management experience in a health care research setting.
