Clinical Research Coordinator
Location
Plymouth, MA | United States
Job description
At Headlands Research, we are building a best in class clinical trial network. 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 clinical trial sites in the US and Canada with rapid plans for expansion.
This is a full-time position based at our location in Plymouth, MA.
You can read more about us at
The Role
The Clinical Research Coodinator will assist the Principal Investigator (PI) in implementing clinical research studies at the site as assigned.
- Manage all study related activities in accordance with protocol requirements.
- Ability to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
- Responsible for assisting in the recruitment of study participants. Assesses potential study patients and eligibility for inclusion in a particular protocol based on protocol requirements.
- Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.
- Completes follow-up with study participants in prescribed settings as required.
- Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
- Coordinating resolution of all data queries.
- Complies with all institutional policies and government regulations pertaining to human subject protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the PI, the study sponsor and Institutional Review Board (IRB).
- Responsible for assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
- Performs basic laboratory activities as needed.
- Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
- Arranges necessary tests and procedures in accordance with protocol requirements.
- Performs necessary tests as needed and as appropriate to level of training.
- Organizes and participates in monitoring visits with the study sponsor to review completeness and accuracy of study documentation.
- Maintains inventory of all study supplies.
- Experience with CRIO (Clinical Trial Management System) is a plus.
- Other duties as assigned.
JOB KNOWLEDGE AND SKILLS:
- High degree of organizational talents
- Requires meticulous attention to detail
- Excellent computer skills
- Ability to prioritize quickly and appropriately
- Excellent communication and interpersonal skills
- Care in organization and systematic record-keeping
- Previous experience in clinical trials
EDUCATION:
EXPERIENCE:
- A minimum of 2 years experience in research related activities as a Clinical Research Coordinator.
- An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements.
WORKING CONDITIONS/PHYSICAL DEMANDS:
- Typical clinical and administrative office setting.
- Must be able to perform all essential functions of this position with reasonable accommodation if disabled.
- May access PHI/HIPAA identifiers as part of daily tasks.
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