Coordinator Clinical Research

McLaren Health Care; Flint (MI); On-site; USD 52,000 - 76,000; Full time

Job summary

McLaren Health Care is seeking a Clinical Research Coordinator to facilitate studies, assess eligibility, and guide patients and staff through protocol procedures.

You will coordinate data collection, ensure regulatory compliance, and support investigators in enrolling participants and submitting study data to sponsors as required.

Qualifications

• Requires high school diploma or equivalent.
• Two years’ experience in clinical research or five years in a health care role.

Responsibilities

• Evaluate eligibility of candidates for clinical trials.
• Assist with informed consent process ensuring patient understanding.

Skills

Clinical research knowledge

Informed consent process

Data collection & entry

Regulatory compliance

Education

Biology/psychology degree

Clinical research certification (SOCRA/ACRP)

Job description

The McLaren system includes 12 hospitals across the state, ambulatory surgery centers, imaging centers, a 730-member employed primary and specialty care physician network, commercial and Medicaid HMOs covering more than 242,000 Michigan lives, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network, and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, a National Cancer Institute-designated comprehensive cancer center. McLaren has 20,000 full-, part-time and contracted employees and more than 93,000 network providers throughout Michigan.

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 :

1. 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.

2. 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.

3. Registers and randomizes eligible patients.

4. Submits accurately completed data collection forms to the sponsor or CRO in a timely manner as dictated by the study protocol.

5. 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.

6. 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.

7. Assists the investigators and clinicians in identifying and enrolling eligible patients into clinical trials/ studies and assures compliance to protocol requirements.

8. 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

Additional Information

• Schedule: Full-time
• Daily Work Times: 8am - 4:30pm
• On Call: No

McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.

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McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status,national origin, disability, genetic information, height or weight, protected veteran or other classificationprotected by law.