Job Information
University of Michigan Clinical Research Coord Lead in Ann Arbor, Michigan
Clinical Research Coord Lead
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Job Summary
The Neurology Clinical Trials Organization (NeCTO) is seeking an experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team. This position will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of neurological clinical research studies. This position willprovide study coordination for multiple clinical research studies of any complexity and functional supervision for one or more junior clinical research coordinators. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities. This position will report directly to the NeCTO Manager.
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*
BASIC FUNCTION AND RESPONSIBILITY
This position provides study coordination for multiple clinical research studies of any complexity and in multiple patient care settings (i.e. outpatient, inpatient, ICU, ED). This position will provide functional supervision for 1 or more junior study coordinators and will lead study team members in the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include design, develop, evaluate, lead, guide, mentor, and support.
CHARACTERISTIC DUTIES AND RESPONSIBILITIES: CRC-Lead
20% Clinical Coordinator
Develops tools, processes, and training to enhance the administration and execution of clinical trials.
Designs processes and tools to assess study execution and leads team on accurate implementation of protocol. This may include the development of manuals of operation and study workflows or other team critical process documents.
Develops processes, tools, and training to support the non-GCP-related activities associated with study execution.
Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures.
Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently.
20% Data Coordinator Responsibilities
Oversees data quality.
Performs at the highest level of data management and results reporting ensuring timeliness.
20% Regulatory Coordinator Responsibilities
Develops processes, tools, and training to enhance site compliance with regulatory requirements necessary for the safe and effective development of investigational products.
Ensures regulatory documentation is accurate, up to date, complete.
Monitors site compliance with subject safety reporting, escalates issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study.
30% Administrative Responsibilities
Leads a team of coordinators in support of clinical research.
Functional supervision of 1 or more clinical research staff professionals.
Demonstrates professionalism and applies well-developed leadership practices in all aspects of the role of the CRC.
Oversees study conducted by staff and guides quality assurance efforts.
Responsible for recommendations on workload assessments and distribution.
Develops processes, tools, and training to support the GCP-related activities associated with study execution.
Assists with Standard Operating Procedure development and implementation.
Ensures study documents are appropriately stored after study termination per NeCTO operations.
10% Training
Develops and conducts training for staff and others.
Provides mentorship as needed within the unit.
Attends and participates in all training assigned at this level including maintaining certification for ACRP or SoCRA.
Participates in internal quality control review of study processes and documents.
CHARACTERISTIC DUTIES AND RESPONSIBILITIES: CRC-Senior
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. CRC-Senior may report directly to the NeCTO Manager or a NeCTO Project Manager.
SUPERVISION EXCERCISED
CRC-Lead provides functional Supervision of one (1) or more staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, CRC Intermediate, or CRC Senior. CRC-Senior would not provide functional.
Required Qualifications*
CRC Lead:
CRC Governance Committee review and approval.
Bachelor's or Master'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 SoCRA or ACRP )
Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional 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.
CRC Senior:
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 SoCRA or ACRP )
Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
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.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Detail
Job Opening ID
252152
Working Title
Clinical Research Coord Lead
Job Title
Clinical Research Coord Lead
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Onsite
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Neurology Department
Posting Begin/End Date
8/08/2024 - 9/30/2024
Career Interest
Research
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