Clinical Research Coordinator (level dependent on experience)
About The Position
The Clinical Research Coordinator is responsible for coordinating the conduct of Phase I through Phase IV clinical research studies. This role ensures all studies adhere to Good Clinical Practices (GCPs), International Harmonization Guidelines, and Standard Operating Procedures (SOPs), from pre-study planning through the successful completion of all study visits. Key aspects include maintaining protocol knowledge, recruiting subjects, managing study documentation, ensuring compliance during visits, maintaining subject safety, interacting with investigators and sponsors, and attending necessary meetings. The coordinator is expected to actively seek development opportunities and comply with all company policies and applicable laws.
Requirements
- 1+ year of experience as a clinical research coordinator or in a similar position within the medical or mental health field
- Bachelor’s degree in life sciences or equivalent combination of related experience and education in the medical or mental health field
Nice To Haves
- Clinical Research Coordinator Certification (CCRC) is preferred
- Associate or Bachelor’s Degree in Nursing is preferred
- Advanced Cardiac Life Support (ACLS) is preferred
Responsibilities
- Maintain a good level of knowledge and understanding of assigned protocols, including all protocol requirements for study visits, obtaining informed consent, study visit schedules, tests, procedures, laboratory information, and drug accountability requirements
- Recruit subject volunteers for studies; Work with the Recruitment Department with developing study-related materials and interview questionnaires
- Create source templates for study documentation, complete case report forms, and other study specific documents seeking assistance from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader or Clinical Site Director, as needed
- Ensure consistency and effective communication during study visits and assure all procedures are conducted in compliance with the clinical protocol; Maintain subject safety, assess feedback from study participant and refer to investigators or other professionals as needed; If applicable, administer study medications based on state licensure, account for medications used
- Coordinate and conduct study visits; Assure all procedures are conducted in compliance with the clinical protocol and in accordance with all applicable regulations and in compliance with GCPs
- Interact with Investigators or study sponsors as needed to assure the study participant receives appropriate medical evaluation and care when needed
- Interact with the sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process
- Attend sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
- Conduct clinical research in compliance with all applicable regulations; Request assistance and technical advice from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader, or Clinical Site Director, as needed
- Actively seeks out development opportunities
- Behave cooperatively and constructively; Follow all company policies, state, local, federal, and other applicable laws and guidelines; Comply with all job-specific requirements
Benefits
- Support career progression through a structured mentoring program and leadership courses
- Ongoing education and training through tuition reimbursement and a dedicated training department
- Award-winning unparalleled culture
- Support for work-life balance and time with family through generous health benefits and vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- CTI Cares program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
