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Clinical Research Coord Lead

4 months ago

Ann Arbor, United States University of Michigan Full time

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

Contribute to the development of process and tools within all 8 competency domains is expected:

Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork

20% - Clinical Coordinator Responsibilities

Contributes to the development of processes and tools to support the non-GCP and GCP-related activities associated with study execution Performs complex study procedures with accuracy Develops processes and tools to address subject concerns efficiently Capable of conducting all startup, active implementation, and closeout activities

20% - Data Coordinator Responsibilities

Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA) Develops processes, tools, and training to capture data in accordance with ALCOA-C principles Demonstrates the ability to create and manage databases

20% - Regulatory Coordinator Responsibilities

Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study Oversees regulatory documentation for quality assurance Contributes to the development of processes and tools to enhance site compliance with the requirements necessary for the safe and effective development of investigational products

30% - Administrative Responsibilities

Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved Runs regular study meetings Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy; Develop standard operating procedures, work-aids and other guidance

10% - Training

ex. - Provides mentorship of other clinical research staff; maintains certification

SUPERVISION RECEIVED

CRC-Lead position will report directly to the NeCTO Manager. 

SUPERVISION EXCERCISED

CRC-Lead provides functional Supervision of one or more staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, CRC Intermediate, or CRC Senior. CRC-Senior could provide functional supervision (likely in limited capacity such as training) of staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, or CRC Intermediate.

Required Qualifications*

CRC Governance Committee review and approval. Bachelor's degree in Health Science or an equivalent combination of related education and experience. Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from qualifying experience prior to applying. Professional demeanor and excellent interpersonal and communication skills. Experience with Microsoft Office products (i.e. Microsoft Word, Excel, and Power Point) Confident and highly motivated with excellent multi-tasking ability and record-keeping skills. Outstanding organizational skills with meticulous attention to detail. Strong ability to work independently, exercising good judgement, with minimal supervision. Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner. Strong problem-solving skills. Ability to adhere to established timelines to accomplish tasks. Demonstrated ability to learn and use new skills quickly and effectively. Able to maintain data confidentiality and participant/subject/patient privacy. Excellent attendance record and strong work ethic. Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations.

Desired Qualifications*

Licensed RN or equivalent medical training or equivalent experience Direct interactions with patients/family in an inpatient care setting or outpatient clinic.  At least 2 years research experience with federally-sponsored and/or industry-sponsored clinical studies. Strong experience using e-Research Regulatory Management system, OnCore Clinical Trial Management System, and MiChart. Experience with Electronic Data Entry/Capture (EDC). A working knowledge of medical terminology and assessment of laboratory values. ACRP or SOCRA certified. ICH-GCP certified through CITI, HIPAA, and PEERRS training complete and up-to-date. Experience in database development and management (including developing surveys) using REDCap.
 

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.