- Assure all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
- Maintain logs, including tracker submissions and update the CTO Oncore database in a timely manner according to CTO SOPs.
- Manage all patient and /or protocol data as assigned, respond to queries in a timely fashion.
- Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required.
- Assist multidisciplinary team in research activities. Serve as a consultant to faculty and support staff.
- Bachelor's degree and two or more years experience coordinating clinical trials: or equivalent combination of education/experience that includes at least four years in the clinical trials arena.
- Medical and/or science experience/education strongly preferred.
- Clinical research certification required prior to assuming Clinical Research Coordinator IlI role.
- Thorough understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance.
- Proficient with the Microsoft suite including Excel and Power point.
- 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.
- Skilled in communicating sensitive/difficult information and maintaining highly confidential information and situations.
- Demonstrated high level of interpersonal skills and analytical ability.
- Excellent writing and organizational skills
- Demonstrated leadership abilities required including mentoring and training.
- Demonstrated initiative and attention to detail including coordination of complex studies and increased workload.
- Successful completion of Level III promotion presentation to applicable CTO Management demonstrating the above qualifications and competencies.
- Schedule: Full-time
- Requisition ID:
- Daily Work Times: TBD
- On Call: No
- Weekends: No
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Clinical Research Coordinator III - Detroit, United States - McLaren Health Care
Description
Provide experienced study coordinator/data management/regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment as well as providing training and mentoring to team members as required. Manage supervisor responsibilities as required. This position is integral to the overall efficient operation of the CTO. Facilitate excellent customer service and guidance in the clinical trials arena.Responsibilities:
Additional Information
McLaren Health Care is an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.