- Ensure 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 Oncore database in a timely manner, according to CTO SOPs
- Manage all patient and /or protocol data as assigned, and respond to queries in a timely fashion.
- Schedule and participate in monitoring visits and participate in MDT team program meetings; serve as a consultant/liaison for research activities.
- Develop solutions to complicated issues relating to KCI research processes and core support; then educate other CTO staff members.
- Bachelor's degree and at least four years' experience coordinating clinical trials: or equivalent combination of education/experience that includes five or more years coordinating clinical trials.
- Clinical Research Professional or Association of Clinical Research Professionals (ACRP) required for a minimum of 12 months prior to assuming CRC IV 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.
- Demonstrated initiative and attention to detail.
- Medical and/or science experience/education preferred.
- Schedule: Full-time
- Requisition ID:
- Daily Work Times: TBD
- On Call: No
- Weekends: No
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Clinical Research Coordinator IV - Detroit, United States - McLaren Health Care
Description
Position Summary:
Provide experienced Clinical Research Coordinator (CRC) support to the Clinical Trials Office (CTO) and Multidisciplinary Team (MDT) team.
Independently manage a variety of assignments (including complex, early phase and multifaceted studies) as well as provide training and mentoring to KCI research team members.
Function as primary support to service specific CRC Supervisor, providing coverage, as needed. This position is integral to the overall efficient operation of the CTO and activities related to research. Facilitate excellent customer service and guidance in the clinical trials arena.Essential Functions and Responsibilities:
Qualifications:
Required:
Preferred:
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.
