Clinical Research Coord Lead

2 weeks ago

Ann Arbor, United States University Of Michigan Full time

How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

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 will provide 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.

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.

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 (1) 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 SoCRA

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