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.
Through the commitment of 1,000 staff, including nearly 300 faculty members, and supported by thousands of volunteer and financial donors, Karmanos strives to lead in transformative cancer care, research and education through courage, commitment and compassion. Our long-term partnership with the Wayne State University School of Medicine enhances the collaboration of critical research and academics related to cancer care.
Clinical Research Coordinator II Job Summary:
Provide study coordinator/data management/regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing excellent customer support and guidance in the clinical trials arena.
1. Assure all study requirements are met and documented and meet both internal and external regulations in accordance with protocol guidelines.
2. Maintain logs, including tracker submissions and update the CTO Oncore database in a timely manner according to CTO SOPs.
3. Design systems for coordinating, compiling and submission of data; design workflow processes and participate in quality assurance measures; coordinate site visits.
4. Manage all patient and/or protocol data as assigned and respond to queries in a timely fashion.
5. Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required.
6. Assist multidisciplinary team in research activities. Serve as a consultant to faculty and support staff.
7. Maintain study binders and filing according to protocol requirements and CTO policy.
8. Participate in the development of general goals of the CTO.
9. Assure protocol compliance as it relates to assignment.
10. Manage own deadlines to maintain data integrity
11. Adhere to all KCI & CTO policies and procedures.
Clinical Research Coordinator II Qualifications:
1. Bachelor’s degree required or equivalent combination of education and experience.
2. Medical and/or science experience/education preferred.
3. Clinical research certification preferred.
4. One or more years experience in clinical trials required. Or demonstrated mastery of competencies of a Clinical Research Coordinator II.
5. Demonstrated understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance.
6. Proficient with the Microsoft suite including Excel and Power point.
7. Demonstrated initiative and attention to detail.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Please apply at https://mclarenhlth.taleo.net/careersection/mclaren_external_career_section/jobdetail.ftl?job=21002474&tz=GMT-04%3A00&tzname