Clinical Research Coordinator I

Headlands Research•Maplewood, MN

7d•Onsite

About The Position

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. Clinical Research Coordinator (CRC) 📍 Location: Maplewood, MN | 🏥 Site Name: Headlands Research - Twin Cities| 🕒 [[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. We’re seeking a Clinical Research Coordinator (CRC) for our clinical research site located in Maplewood, MN. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry. Type: Regular Full-time Employee Schedule: Mondays through Fridays, 8:00am - 4:30pm Location: Onsite in Maplewood, MN (no capabilities for remote or hybrid work) Reports to: Site Director

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
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

Nice To Haves

vaccine study experience a plus

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