Research Study Coordinator I - 40 hrs/wk - Days - Detroit

GENERAL SUMMARY:
Under minimal supervision, coordinates research projects within guides of regulatory
compliance and/or Code of Federal Regulation. Provides technical support to Principal
Investigators. Duties include but not limited to, interacting with both internal and external
customers at all levels and oversight of recruitment and coordinating day-to-day
operations of the study. Direct contact with potential and enrolled study participants
expected. Provides other support as required.

PRINCIPLE DUTIES AND RESPONSIBILITIES:
Project Coordination
1. Reviews and comprehends the protocol. Familiar with using project specific
databases, including but not limited to recruitment, specimens, supplies, etc.

2. Coordinates and provide tours of various areas with Henry Ford Health and its
satellites. Demonstrates Henry Ford Health's ability to comply with Good Clinical
Practice, Code of Federal Regulations and/or similar regulations.

3. Establishes and organizes study files, including but not limited to regulatory binders, study specific source documentation and other materials.

4. Attends investigator oversight meetings.

5. Provides training and oversite to project team members

Regulatory & Compliance
1. Understands research protocols and regulatory standards to ensure procedural and
data completion and accuracy.

2. Prepares parts of regulatory submissions and contributes to development of consent
forms under supervision of Principal and/or other project leads.

3. Documents all data and activities, following standard operating procedures and
quality control.

4. Monitors and reports adverse events, protocol deviations as well as other privacy
and safety incidents under the supervision of Principal Investigator and/or other
project lead.

5. Maintains project documents and regulatory binders under guidance of Principal
Investigator and/or other project

Recruitment & Oversight
1. Under guidance of PI and/or other project leads, assists in recruiting research
participants as needed and retaining participants in research studies/projects.

2. Coordinates and interacts with participants or potential participants along the
continuum of the study (enrollment, engagement, recruitment, data/sample collection, retention). Coordinates recruitment team schedules under guidance of guidance of
PI and/or other project leads.

3. Implements study protocol in recruitment space/clinics in collaboration with clinic
staff and under guidance of PI and/or other project leads. Develops recruitment
strategies. Assists in setting up recruitment space/clinics in collaboration with clinic
staff.

4. May draft sections of processes and support specimen collection by research staff.
Interacts with the study investigator regularly, ensuring patient safety and adherence
to proper study conduct.

5. Serves as primary contact with research participants, sponsors, and regulatory
agencies. Manages and tracks distribution of study related incentives.

Conduct of Research
1. Reviews and develops a familiarity with the protocol, study proceedings and
timelines, inclusion, and exclusion criteria, etc. Disseminates and ensures the
understanding of information to all other study staff involved with the study.

2. Under PI supervision, enrolls the patient into the clinical trial and communicates
treatment assignment to clinical team.

3. Provides methodological and technical support to principal investigators. Coordinates research projects and implements quality measures to assure
compliance. Educates investigator and clinicians regarding study requirements and
oversees compliance.

4. Coordinates efforts from various departments to ensure central submission of
radiology, pathology, and cardiology materials, supporting clinical research studies.

5. Acts as patient advocate for central review of precision medicine materials, ensuring
timeliness and responsiveness of the central lab reports that determine initiation of
the specific course of treatment for the patient.