Clinical Research Coord Senior

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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. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities. The position will report directly to the NeCTO Manager as the administrative supervisor. The position may have functional supervision from a NeCTO Project 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 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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

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

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 orACRP )
• 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.
  

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.

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.