Karmanos Cancer Institute, headquartered in Detroit, understands that beating cancer means bringing together the best. Cancer is a complex disease that demands complex care. With 15 locations throughout Michigan and proudly a part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in the state. Cancer patients have increased access to advanced cancer care in communities throughout the state. This provides an extra level of comfort and peace of mind to patients and their families, knowing they can receive the best care locally.
Caring for approximately 12,000 new patients annually and conducting more than 800 cancer-specific scientific investigation programs and clinical trials, Karmanos is among the nation’s best cancer centers. Karmanos offers one of the largest clinical trials program in the nation, giving patients access to more than 250 promising new treatments often not found at other hospitals or health organizations.
Quality Assurance Specialist Job Summary:
Provides clinical trials auditing and monitoring and follows established processes to support compliance according to KCI Data and Safety Monitoring Plan and all applicable regulations. Provides support for all facets of clinical trials auditing and monitoring with special emphasis on institutional (investigator-initiated) and Cooperative Group sponsored trials. This position is integral to the overall compliance of clinical trial research and the protection of the rights and well-being of study participants.
1. Conducts a variety of compliance activities intended to facilitate and assure that clinical trials comply with the requirements of the protocol, the approving Institutional Review Board, Code of Federal Regulations, Good Clinical Practice, Food and Drug Administration (FDA), and KCI’s NCI approved Data and Safety Monitoring Plan.
2. Conducts auditing and monitoring activities in accordance with established CTO policies and procedures.
3. Activities may include: pre-study feasibility evaluations, ongoing monitoring of studies and study close-out, drug, device and correlative specimen compliance review.
4. Reviews the accuracy, completeness and timeliness of study related records, and case report forms with original source documents.
5. Reviews that study related processes relative to departmental guidelines and SOPs are in compliance.
6. Works cooperatively with clinical research staff and investigators to communicate findings that can lead to improved clinical trial performance and compliance.
7. Utilizes appropriate auditing and monitoring tools, and CTMS to record and report findings.
8. Participates in the development of general goals, process improvement plans, and training activities related to research compliance.
9. Maintain positive relationships with employees and representatives of various internal and external departments.
1. Bachelor’s degree and four plus years’ experience coordinating clinical trials: or equivalent combination of education/experience that includes at least five years in the clinical trials arena.
2. Medical and/or science experience/education strongly preferred.
3. Clinical research certification required for a minimum of one year.
4. Clinical trial auditing and monitoring experience preferred.
5. Exceptional interpersonal skills required and excellent verbal and written communication skills necessary to effectively deal with individuals both inside and outside the organization from diversified backgrounds.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Please apply at https://mclarenhlth.taleo.net/careersection/mclaren_external_career_section/jobdetail.ftl?job=21002476&tz=GMT-04%3A00&tzname=America%2FNew_York