What are the responsibilities and job description for the Clinical Research Coordinator position at Headlands Research?
Overview
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 20 clinical trial sites in the US and Canada with rapid plans for expansion.
The Role
Headlands Research Detroit is looking for a Clinical Research Coordinator to manage clinical research protocols. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines.
Responsibilities
- Comprehend study design of each protocol that is assigned
- Perform procedures in compliance with the study protocol
- Recruit and screen study subjects according to specific protocol requirements
- Collect and record study data in source documents via electronic system (CRIO)
- Manage study related activities
- Adherence to protocol requirements
- Review laboratory data
- Assess and document compliance
- Manage investigational product
- Assess, record, and report Adverse Events as outlined in the protocol
- Manage/train ancillary staff
Qualifications
Education:
- Experience and training in conducting clinical trials with knowledge of ICH GCP
OR
- Two years of college in a health-related program or LPN
OR
- Bachelor’s degree in a health or scientific related program
- A thorough understanding of regulatory requirements
- Excellent interpersonal and communication skills: Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
- Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
- Experience with CRIO (Clinical Trial Management System) is a plus
- Experience with administering vaccines is a plus
