Clinical Research Coordinator
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What you'll do
- Coordinate all aspects of assigned clinical trials from site initiation to study close-out
- Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards
- Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs
- Manage subject recruitment, informed consent, and retention strategies
- Ensure timely data entry and resolution of EDC queries
- Report and follow up on all adverse events, serious adverse events, and deviations
- Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders
- Prepare for and participate in monitoring visits, audits, and inspections
- Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems
- Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)
- Attend investigator meetings and provide cross-functional support as needed
- Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control
What they're looking for
- Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP
- Previous experience as a Clinical Research Coordinator required
- Familiarity with electronic data capture (EDC), IVRS, and other trial platforms
- Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures
- Proficiency in medical terminology and clinical documentation practices
- Strong interpersonal, verbal, and written communication skills
- Organized, detail-oriented, and capable of managing multiple priorities
- Proficient in Microsoft Office and other clinical research systems
Nice to have
- Industry-sponsored trial experience strongly preferred (vaccine study experience a plus)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.
📍 Location: Detroit, MI | 🏥 Site Name: Headlands Research - Detroit | 🕒 Full-Time | 🧪 Clinical Research
Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials.
Headlands Research – Metro Detroit is a leading clinical research site dedicated to advancing medical innovation and expanding access to clinical trials. Strategically located in the Detroit metro area, we serve a large and diverse population while conducting multi-therapeutic and general medicine studies. We are committed to ensuring all participants have access to cutting-edge therapies, helping to shape a healthier future for the communities it serves.
We’re seeking a Clinical Research Coordinator for our clinical research site located in Detroit, MI.
Want to be a part of a growing company that’s making a difference in our world? Look no further than Headland Research! You’ll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees:
Type: Regular Full-time Employee
Schedule: Mondays through Fridays, 8:00am - 5:00pm
[[Pay Range: $26-28/hr *Dependent upon relevant experience, certification, and education.
Location: Onsite in Southfield, MI (no capabilities for remote or hybrid work)
Reports to: Clinical Research Manager]]
Benefits: Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.
💼 What We Offer
- Competitive pay + annual performance incentives
- Medical, dental, and vision insurance
- 401(k) plan with company match
- Paid time off (PTO) and company holidays
- A mission-driven culture focused on advancing medicine and improving patient outcomes
🚀 Why Join Us?
You’ll be part of a growing, mission-driven organization that values its people. At our core, we’re committed to bringing innovative medical treatments to patients faster—while creating an environment where employees thrive. If you’re passionate about clinical research and ready to make a difference, we’d love to hear from you.
Responsibilities:
- Coordinate all aspects of assigned clinical trials from site initiation to study close-out
- Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards
- Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs
- Manage subject recruitment, informed consent, and retention strategies
- Ensure timely data entry and resolution of EDC queries
- Report and follow up on all adverse events, serious adverse events, and deviations
- Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders
- Prepare for and participate in monitoring visits, audits, and inspections
- Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems
- Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)
- Attend investigator meetings and provide cross-functional support as needed
- Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control
Requirements:
- Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP
- Previous experience as a Clinical Research Coordinator required
- Industry-sponsored trial experience strongly preferred (vaccine study experience a plus)
- Familiarity with electronic data capture (EDC), IVRS, and other trial platforms
- Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures
- Proficiency in medical terminology and clinical documentation practices
- Strong interpersonal, verbal, and written communication skills
- Organized, detail-oriented, and capable of managing multiple priorities
- Proficient in Microsoft Office and other clinical research systems
Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind.
Headlands Research is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Need Assistance?
Headlands Research is committed to providing access and reasonable accommodation in its employment for individuals with disabilities. To request disability accommodation in the application process, contact recruiting@headlandsresearch.com for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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