Coordinator Clinical Research

mclarenhlth; Flint (MI); On-site; USD 52,000 - 76,000; Full time

Job summary

McLaren Health in Flint, MI is seeking a Clinical Research Coordinator to facilitate studies, evaluate eligibility, and coordinate protocol procedures with medical teams. The role includes assisting in informed consent, enrolling patients, and ensuring timely data submission to sponsors.

Preferred qualifications include a biology or related degree and SOCRA/ACRP certification, with 3+ years in clinical research highly valued. Equal opportunity employer.

Qualifications

• High School Diploma or equivalent.
• Two years’ experience in clinical research or five years in a health care role.
• Degree in biology, psychology, or related area preferred.
• Three or more years of experience in clinical research preferred.
• Clinical research certification through SOCRA or ACRP preferred.

Responsibilities

• Evaluate eligibility of candidates for clinical studies per protocol requirements.
• Assist investigator with informed consent ensuring adequate information.
• Register and randomize eligible patients.
• Submit completed data forms to sponsor or CRO as dictated by protocol.
• Coordinate tests and procedures per protocol with staff and physicians.
• Maintain regulatory submissions to IRB and regulatory specialists.
• Educate patients and families about protocols and changes in studies.

Education

High School Diploma or equivalent

Degree in biology or related field

Clinical research certification SOCRA/ACRP

Job description

Position Summary:

Responsible for facilitating research studies; providing knowledgeable information regarding each research protocol to the medical and nursing staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and maintain a system for effective data flow.

Essential Functions and Responsibilities:

• Evaluates eligibility of candidates for clinical research studies by reviewing protocol defined eligibility requirements and/or collecting pertinent data on potential candidates, verifying appropriateness of patients for entry to clinical trials, and assisting the other staff in determining eligibility of potential patients.
• Assists the investigator with the informed consent process and assures that the research team and the patient have adequate information to achieve the informed consent process.
• Registers and randomizes eligible patients.
• Submits accurately completed data collection forms to the sponsor or CRO in a timely manner as dictated by the study protocol.
• Coordinates tests and procedures as specified in the study protocol through accurate communication with the site / principal investigator, physicians, patients, nurses, and office/hospital staff.
• Maintains contact with regulatory specialist to ensure data submitted to the IRB of record is accurate and timely. Upon request, submits regulatory documents to regulatory specialist to include in the IRB submission or submission to sponsor or CRO.
• Assists the investigators and clinicians in identifying and enrolling eligible patients into clinical trials/ studies and assures compliance to protocol requirements.
• Educates patients and their families regarding research protocols and keeps them informed of procedures and changes in the studies in which they are participating.

Qualifications:

Required:

• High School Diploma or equivalent
• Two years’ experience in clinical research or five-years in a health care role (ex. paramedic, emergency medical technician, radiology technician)

Preferred:

• Degree in biology, psychology, or other clinical research -related area or equivalent education and experience
• Three or more years of experience in clinical research
• Clinical research certification through SOCRA or ACRP

Equal Opportunity Employer of Minorities/Females/Disabled/Veterans