Clinical Research Coordinator (level dependent on experience)

About the role

Coordinate the conduct of Phase I through Phase IV clinical research studies in accordance with Good Clinical Practices (GCPs), International Harmonization Guideline and Standard Operating Procedures (SOPs) beginning with pre-study planning through successful completion of all study visits.

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 to develop 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 participants, and refer to investigators or other professionals as needed.
• If applicable, administer study medications based on state licensure and 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 GCPs.
• Interact with Investigators or study sponsors as needed to assure the study participant receives appropriate medical evaluation and care.
• 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 seek 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.

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.
• Clinical Research Coordinator Certification (CCRC) is preferred.
• Associate or Bachelor’s Degree in Nursing is preferred.
• Advanced Cardiac Life Support (ACLS) is preferred.

Benefits

• Advance Your Career – Support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. Value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – Award-winning unparalleled culture felt by employees across 60 countries. Support work-life balance and time with family through generous health benefits, vacation packages, hybrid work-from-home opportunities, and paid parental leave. Encourage care for the world through the unique CTI Cares program.
• Make a Lasting Impact – Focus on moving medicine forward by working on treatments for chronically and critically ill patients who depend on life-changing therapies.