Job Details
Mantell Associates is currently seeking a highly experienced Senior Clinical Research Coordinator for a top-tier clinical research organization. This is an excellent opportunity for someone with surgical study experience who is passionate about advancing medical research and ready to take their career to the next level.
Senior Clinical Research Coordinator - Responsibilities:
- Responsible for managing all study-related procedures, distributing study medications, and providing instructions to research subjects
- Work closely with the Principal Investigator and Site Director to ensure accurate and confidential documentation of study participants, adhering to all regulatory standards and protocols
- Thoroughly review and understand study protocols with the Principal Investigator and Site Director prior to study commencement
- Lead and coordinate the activities of other coordinators and interface with CRA and company personnel assigned to the study
- Develop and review draft source documents for accuracy and clarity
- Establish and maintain subject recruitment mechanisms and ongoing communications with PCP and nursing staff
- Conduct all aspects of the clinical trial, including recruitment, screening, enrollment, and follow-up of subjects according to protocol requirements
- Ensure organizational management of caseloads and study files
- Manage study compliance with protocol requirements, sponsor guidelines, and regulatory standards
- Assist in obtaining informed consent from potential study volunteers and document all communications with sponsors, labs, IRB, and other regulatory organizations
- Maintain organized, accurate, and complete study records, ensuring timely and accurate CRF completion
- Report and track adverse events as per study protocols
- Perform study close-out procedures and appropriately store study records.
Senior Clinical Research Coordinator - Requirements:
- High School Diploma or equivalent; College degree preferred
- 5+ years of experience as a Clinical Research Coordinator
- Proficient in understanding regulatory requirements, GCP, and ICH guidelines
- Knowledgeable in medical terminology and able to communicate effectively with providers, co-workers, sponsors, and other stakeholders
- Demonstrate initiative and the ability to make decisions within study protocols and regulatory constraints
- Excellent communication skills (interpersonal, written, verbal)
- Basic computer skills including proficiency in Word, Excel, and industry-specific applications
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting organisation. For more information on this role, contact us at +1 (786) ### ####.