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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.

EDUCATION/EXPERIENCE REQUIRED:

+ Bachelor’s degree in a scientific field, Psychology, Sociology, Anthropology or related

field.

CERTIFICATIONS/LICENSURES REQUIRED:

+ SOCRA or ACRP and IATA certification preferred.

Additional Information

+ Organization: Henry Ford Medical Group

+ Department: Gastro Procedure - Main

+ Shift: Day Job

+ Union Code: Not Applicable

Additional Details

This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.

Overview

Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services – from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford’s care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation’s most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers .

Benefits

The health and overall well-being of our team members is our priority. That’s why we offer support in the various components of our team’s well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits.

Equal Employment Opportunity/Affirmative Action Employer

Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is

committed to the hiring, advancement and fair treatment of all individuals without regard to

race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height,

weight, marital status, family status, gender identity, sexual orientation, and genetic information,

or any other protected status in accordance with applicable federal and state laws.