Summary

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

Responsibilities*

CHARACTERISTIC DUTIES AND RESPONSIBILITIES Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs. * 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 Essential

**: 20% Clinical Coordinator Responsibilities (ex.  Assist with screening participants for study eligibility & enroll with accuracy in various databases; May complete simple study reimbursement with partners; May provide lab results, not interpretation, to participants)  Perform moderately complex study procedures with accuracy.  Triage simple study concerns and issues appropriately. Understand protocol structure and how to interpret study requirements to assess study compliance and ensure quality control.  Complete simple to moderately complex data collection tasks and understand and follow proper documentation techniques.  Help with participant remuneration.  Attend and participate in all follow up team meetings

. 20% Data Coordinator Responsibilities (ex.  May assist research coordinator in conduct of SIV; attends SIV; Enters data to complete forms (CRFs) on paper or in EDC)  Enter data carefully and accurately.  Help with data cleaning tasks.  Resolve simple to moderately complex data queries. 

20% Regulatory Coordinator Responsibilities (ex.  May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.); Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines.) Help to prepare IRB and other progress reports. May gather participant approval via informed consent. Demonstrate the ability to manage increasing levels of protocol complexity or volume efficiently. Demonstrate the ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information of Events (ORIOs), and understands how to report appropriately.

30% Administrative Responsibilities (ex.  Provide other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.) Demonstrate an understanding of the clinical research objectives associated with the program.  Communicate clearly and professionally with study participants by phone, text, email, and mail.  Schedule subjects for follow up interviews.  Help manage study supply inventory.  Use documents and systems to track recruitment and retention of participants. Conduct risk assessments with participants as needed.  Conduct follow up interviews and follow research protocols for scheduling participant follow-up sessions.  May work with regulatory support to maintain regulatory binder. 

10% Training (ex. May receiving task specific training to perform additional research duties as assigned.)  PEERRS, HIPAA, CITI GCP Willing to learn and use available technology and systems to accomplish job requirements.  Attend and participate in all assigned training classes

RELATED DUTIES Ethics and Participant Safety  Demonstrates proficiency in eResearch duties as assigned.  Uses proper documentation techniques as outlined in the ICH-GCP guidelines.  May gather participant approval via a simple consent May assess participant understanding of the research during the consent process and can therefore consent to the study Demonstrates ability to identify AEs and SAEs, ORIOS, and assists with reporting. May submit continuing reviews, amendments, and post correspondence in eResearch  Demonstrates familiarity with essential documents as described in the ICH-GCP guidelines.  Demonstrates the ability to understand the completion and submission of eResearch and OnCore applications. Can explain the basic requirements of an Informed Consent and the importance of such a document regarding the safety and ethical treatment of participants. Identifies key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical trials.  Understands importance of participant confidentiality and complies with HIPAA and U of M regulations Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants Operations  Suggests modifications to improve efficiency of workload and/or workflow.  May assist research team in the conduct of site initiation meetings. May conduct site selection/qualification visits for potentially incoming clinical trials. May communicate with MCRU or other staff completing specimen management to collect data (e.g., pick up/retrieve CRFs from staff, track packages, etc.) Ensures integrity of specimen management (collection, processing, packaging/shipping, storing, labeling, tracking, etc.) Is familiar with basic clinical lab equipment such as a centrifuge, freezers (various), pipettes, and standard laboratory safety requirements and guidelines.  May prepare study procedure kits, shippers, CRFs, and requisition forms. Other Perform other related duties as assigned.

SUPERVISION RECEIVED This position receives direct supervision and should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator. SUPERVISION EXCERCISED None

Required Qualifications*

High school diploma or GED is necessary.

Desired Qualifications*

Associate 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 desirabl

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

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