Senior Research Administrator

Tenet Healthcare • Detroit, MI

6h

About The Position

Embark on a rewarding career with Detroit Medical Center Shared Services. If you are a compassionate healthcare professional eager to contribute to patient care, this is your opportunity where your skills make a difference every day. Join us in delivering exceptional healthcare with a personal touch.

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.

Requirements

• BS/BA Degree.
• Minimum of five years experience as a research coordinator or administrator.
• Four years of progressively more responsible project management experience in a health care research setting.

Responsibilities

• Reviewing, evaluating and auditing clinical research studies submitted for DMC Research Review.
• Conducting billing coverage analyses on clinical studies.
• Consulting with principal investigators and research coordinators on appropriate wording in patient consent forms, study agreements, and protocols to mitigate billing risk.
• Coordinating and designing processes to ensure compliance to protocol and quality data acquisition.
• Coordinating with DMC hospitals' registration, coding, accounting, finance, and billing to assure research revenue cycle is compliant.
• Preparing reports for VHS compliance and Internal Auditing.
• Providing support to investigators, physicians and fellows in compliant study protocol development, regulatory documentation, and protocol procedures.
• Providing DMC research charge information for investigators' study budgets in compliance with NIH guidelines.
• Working with investigators and industry sponsors to accurately capture all billable events to be covered by the sponsor.
• Collaborating with accounting and finance to assure accurate invoicing and billing.
• Overseeing study procedures and maintaining study documentation in accordance with established Good Clinical Practice (GCP) guidelines, Code of Federal Regulations (CFR) Title 21-regulations, and applicable statute(s).
• Assuring IRB approval is obtained prior to initiation of studies.
• Assuring the protection of the patient's rights and safety in collaboration with study investigator(s) and in a manner consistent with the Declaration of Helsinki and Health Insurance Portability and Accountability Act (HIPAA).
• Reporting adverse events according to IRB, Sponsor, and FDA guidelines.
• Collaborating with the IRB of record on overseeing research integrity and patient safety issues.
• Facilitating external monitoring and auditing of research activities.
• Interviewing, scheduling, orienting, and training research coordinators and ancillary staff.
• Reviewing clinical site agreements (contracts) and acting as liaison between involved parties.
• Ensuring that charges for study-related care and subject stipends are properly documented and charged to study guarantor accounts.
• Maintaining awareness of new regulatory issues and identifying new research activities.
• Providing support to supplementary projects that advance the goals of the department and the institution's mission, vision, and values.

Benefits

• Medical, dental, vision, and life insurance
• 401(k) retirement savings plan with employer match
• Generous paid time off (PTO)
• Career development and continuing education opportunities
• Health savings accounts, healthcare & dependent flexible spending accounts
• Employee Assistance program, Employee discount program
• Voluntary benefits include pet insurance, legal insurance, accident and critical illness insurance, long term care, elder & childcare, auto & home insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior