Clinical Research Coordinator – FT
Evolution Research Group
full-time
Posted on:
Location Type: Office
Location: Houston • Texas • United States
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About the role
- Responsible for the overall coordination, organization, management, and efficient implementation of clinical trials
- Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director
- Maintain accurate, confidential files and documentation of study participants
- Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study
- Develop draft source documents and review the documents for accuracy and clarity prior to study start up
- Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate
- Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements
- Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment
- Communication of all protocol related issues/problems to the appropriate management staff
- Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director
- Attend the investigator meeting for each assigned protocol, as appropriate
- Ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required
- Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
- Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
- Maintain organized, accurate and complete study records including regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications
- Ensure timely and accurate CRF completion for each study subject
- Accurately report and track adverse events as defined by each study protocol
Requirements
- High School Diploma or its equivalent; College degree preferred
- Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator
- Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner
- Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff
- Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy
- Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Benefits
- medical and dental coverage
- a matching 401(k)
- paid time off to recharge
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementstudy protocol analysissource document developmentsubject recruitmentadverse event reportingCRF completionregulatory document maintenanceinformed consent managementstudy enrollment programsstudy record organization
Soft Skills
communicationcollaborationinitiativeindependent decision-makingproblem-solvingcourtesyadaptabilityattention to detailorganizational skillsinterpersonal skills
Certifications
Clinical Research Coordinator certification