Headlands Research • Pikesville, MD 21208
Job #2810182274
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
Pharmasite, a Headlands Research site, 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
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