Clinical Research Coordinator
About The Position
Apex Clinical Research Center, in partnership with Apex Skin, is a rapidly growing clinical research organization committed to advancing dermatologic and medical research through high-quality, compliant trial execution. We are seeking a Clinical Research Coordinator who will be responsible for coordinating industry-sponsored clinical trials, ensuring regulatory compliance, maintaining data integrity, and supporting the successful execution of study protocols. The Clinical Research Coordinator works closely with Principal Investigators, Sub-Investigators, sponsors, monitors, and research staff to conduct trials in accordance with IRB-approved protocols, Sponsor requirements, Good Clinical Practice (GCP), and established Standard Operating Procedures (SOPs).
Requirements
- High school diploma or equivalent required; Bachelor’s or Associate degree preferred
- Minimum of two years of experience coordinating industry-sponsored clinical trials
- At least one year of experience in a medical, hospital, or research setting
- Strong written and verbal communication skills
- Ability to frequently lift up to 15 pounds and occasionally transport up to 25 pounds
- One year of laboratory coordination experience
- Experience preparing and submitting IRB applications, including new studies and amendments
- Knowledge of regulatory compliance, GCP standards, and Sponsor expectations
- All patient-facing employees are required to provide proof of a TB test within the past 12 months and an annual flu vaccination as part of Apex’s employee health and safety protocols.
Nice To Haves
- RN certification or certification in Phlebotomy and/or IV infusions preferred
- The Hepatitis B vaccination series is strongly recommended for clinical staff due to potential occupational exposure risks.
Responsibilities
- Identify, screen, randomize, and enroll patients into IRB-approved clinical trial protocols
- Conduct all trial-related procedures in accordance with IRB-approved protocols, Sponsor requirements, SOPs, and Good Clinical Practice (GCP) guidelines
- Perform direct patient care activities including informed consent, physical assessments, blood draws, medication administration, and ECG procedures
- Ensure accurate and timely data entry into Sponsor Electronic Data Capture (EDC) systems and maintain clean, complete study data
- Oversee site initiation activities and support study startup, maintenance, and close-out processes
- Prepare and submit regulatory documentation required for study startup and ongoing trial maintenance
- Maintain and update IRB submissions, amendments, and continuing reviews, resolving regulatory issues promptly
- Create and maintain up-to-date source documentation (paper-based and/or electronic source) for each study
- Review audit findings with the Principal Investigator and Director of Clinical Operations and implement corrective actions as needed
- Identify, document, and report Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and violations accurately and in a timely manner
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
