Clinical Research Technician

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How to Apply

BASIC FUNCTION AND RESPONSIBILITY

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

This position may independently provide study coordination for simple and moderately complex clinical research studies.  As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.  

Responsibilities*

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Experience as part of a team with all 8 competency domains is expected.

1.     Scientific Concepts and Research Design

2.     Ethical Participant Safety Considerations

3.     Investigational Products Development and Regulation

4.     Clinical Study Operations (GCPs)

5.     Study and Site Management

6.     Data Management and Informatics

7.     Leadership and Professionalism

8.     Communication and Teamwork

 

Essential**:

25%  Clinical Coordinator Responsibilities (ex. Performs moderately complex study procedures with accuracy; Triages simple subject concerns and issues appropriately; Assesses studies for execution and troubleshoots potential implementation issues; Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.)

  •         Performs moderately complex study procedures with accuracy.
  •         Triages simple subject concerns and issues appropriately.
  •         Assesses studies for execution and troubleshoots potential implementation issues.
  •         Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
  •         Completes simple to moderately complex data collection during study visits.
  •             May work with CTSUs to reconcile financial accounts for study participants.
  •         Assists with local quality control efforts.
  •         May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment

 

25%  Data Coordinator Responsibilities (ex.Completes simple to moderately complex data collection during study visits; Resolves simple data queries)

  •         Completes simple to moderately complex CRFs.
  •        Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
  •         May assist in CRF development for Investigator Initiated trials.

25%  Regulatory Coordinator Responsibilities (ex. Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)

  •         May complete new eResearch applications.
  •        May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
  •         May gather participant approval via informed consent.
  •        Prepares and participates in internal and external audits.
  •        Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
  •        Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

15%  Administrative Responsibilities (ex.Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)

  •          Demonstrates understanding of the clinical research objectives associated with the program.
  •        May communicate with study participants such as sending study correspondence via mail or email.
  •        May schedule subjects for research visits and FU appointments.
  •         May check study calendar for completion of study procedures.
  •        May manage study supply inventory.
  •        May utilize documents and systems to track recruitment and retention of participants.
  •        May complete and activate postings (advertisements, flyers, etc.) independently.
  •        May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)

10%  Training (ex.Participates in training opportunities on Good Clinical Practices (GCP))

  •        PEERRS, HIPAA, CITI GCP
  •        Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
  •        Willing to learn and use available technology and systems to accomplish job requirements.
  •        Understands the disease process per program.

Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.

RELATED DUTIES

None

SUPERVISION RECEIVED

This position receives direct supervision and reports directly to the Clinical Research Manager.

SUPERVISION EXCERCISED

None

Required Qualifications*

  • Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
  • One of the following:
    • Minimum 1 year of directly related experience in clinical research and clinical trials is necessary
    • An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
    • Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Desired Qualifications*

  • Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.
  • An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.