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The Clinical Research Coordinator manages the planning and execution of clinical trials, ensuring strict adherence to ICH, GCP, and regulatory guidelines. Key duties include coordinating patient visits, maintaining regulatory documentation, and managing study data entry and verification.
Requirements summary
Candidates must possess strong organizational skills and proficiency in EDC and CTMS software. The role requires the ability to work independently in a multidisciplinary team while maintaining high attention to detail in data collection.
Time ManagementDocumentationInterpersonal CommunicationRegulatory CompliancePatient EducationMicrosoft Office SuiteData ManagementPatient CoordinationAdverse Event ReportingICH/GCP GuidelinesElectronic Data Capture (EDC)Clinical Trial Management Software (CTMS)
Job description
Overview
The Clinical Research Coordinator (CRC) is responsible for assisting in the planning, coordination, and execution of clinical trials with strict adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), study protocols, and company/regulatory guidelines.
The CRC supports investigators and research teams in ensuring patient safety, data integrity, and compliance throughout the clinical trial lifecycle—from initiation through close-out.
Key Responsibilities Patient Coordination & Support Assist with coordinating all aspects of patient involvement from study initiation through completion.
Schedule participant visits, procedures, and follow-ups according to protocol timelines.
Provide clear communication and education to participants regarding study expectations, informed consent, and potential risks/benefits.
Study Operations & Data Management Organize and maintain all clinical trial documentation and regulatory binders in compliance with sponsor, IRB, and FDA requirements.
Schedule and oversee collection of study data (labs, imaging, procedures, surveys, etc.).
Observe study subjects and document findings, including adverse events and deviations, per regulatory and protocol standards.
Assist in accurate entry, cleaning, and verification of data into electronic databases (EDC).
Contribute to data analysis, preparation of progress reports, and submission of findings for sponsor and regulatory review.
Protocol & Compliance Adherence Ensure clinical trials are conducted following ICH/GCP, FDA regulations, IRB policies, and sponsor requirements.
Monitor subject safety and report adverse events promptly.
Maintain awareness of trial amendments and implement required changes into workflow.
Participate in audits, monitoring visits, and inspections as required.
Administrative & Logistical Support Coordinate communication between investigators, research staff, sponsors, and study monitors.
Track and manage study supplies, laboratory kits, and equipment inventory.
Assist in organizing investigator meetings, staff training sessions, and study initiation visits.
Support report writing, preparation of study presentations, and other sponsor-required deliverables.
Benefits
Dental Insurance
Paid Time Off
Health Insurance
Vision Insurance
401(k)
Flexible Spending Account (FSA)
Professional development opportunities
Qualification Strong organizational and time management skills with ability to manage multiple trials simultaneously.
Attention to detail and accuracy in data collection and documentation.
Excellent interpersonal and communication skills to interact with patients, families, investigators, and regulatory bodies.
Proficiency in Microsoft Office Suite, EDC systems, and clinical trial management software (CTMS).
Ability to work independently while collaborating in a multidisciplinary team environment.
Work Environment Fully on-site position Collaborative healthcare office environment Regular use of computer systems and documentation review Schedule Full-time | Monday – Friday Minimum 40 hours per week Pay rate $25 per hour Benefits include: Health Insurance Dental Insurance Vision Insurance 401(k) Flexible Spending Account (FSA) Paid Time Off Professional development opportunities If you are passionate about improving healthcare quality and ensuring compliance standards are met, we encourage you to apply and become part of our team.
People with a criminal record are encouraged to apply Work Location: In person This description indicates, in general terms, the type and level of work performed and responsibilities held by the team member(s).
Duties described are not to be interpreted as being all-inclusive or specific to any individual team member.
No Third Party Agencies or Submissions Will Be Accepted.
Our company is committed to creating a diverse environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
DFWP Opportunities posted here do not create any implied or express employment contract between you and our company / our clients and can be changed at our discretion and / or the discretion of our clients.
Any and all information may change without notice.
We reserve the right to solely determine applicant suitability.
By your submission you agree to all terms herein.
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