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*

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 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 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 qualifying experience prior to applying.

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.

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