Clinical Research Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Recruit, enroll, and follow up with study participants in clinical trials under the guidance of the Principal Investigator and Project Manager.

• Coordinate trial participation in accordance with protocols, SOPs, GCP/ICH guidelines, FDA regulations, and other relevant regulations.

• Execute and implement clinical trial activities from the initiation phase to closure.

• Participate in and lead investigator, project, and departmental meetings and training sessions as required.

• Act as a temporary Project Manager for smaller studies when necessary.

• Assess participant eligibility in collaboration with study investigators.

• Screen participants, provide trial information, facilitate informed consent, and enroll participants.

• Assist in the development, review, and distribution of clinical protocols, consent forms, study guidelines, and related documentation.

• Oversee patient care and medication-administration education; ensure accountability of investigational drugs.

• Review changes in participant conditions, adverse events, concomitant medications, protocol adherence, and responses to study drugs; document findings accordingly.

• Collect, document, enter, and report data accurately and promptly.

• Schedule and engage in monitoring and auditing activities.

• Maintain an understanding of assigned protocols and ensure compliance with Sponsor, FDA, and IRB regulations.

• Keep consent forms, case report forms, SAEs, source documents, and regulatory files organized.

• Manage clinical research logistics and project goals effectively.

• Engage in training and educate staff and vendors.

• Collaborate with Project Managers on trial procedures and vendor oversight.

• Offer solutions for process improvement and assist in their implementation.

• Uphold participant confidentiality and ensure a safe research environment in line with HIPAA and applicable regulations.

• Mentor and assist fellow Clinical Research Coordinators.

• For hybrid trials: serve as the site/Sponsor point of contact, develop project and communication strategies, and collaborate with study and multidisciplinary teams.

⛳️ Requirements

• Bachelor's degree (preferred) or a minimum of a two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills.

• Advanced degree preferred but not mandatory.

• At least 5 years of experience in pharmaceutical-sponsored clinical research, or equivalent education, training, and experience in the clinical research domain.

• ACRP (CCRC) or SoCRA (CCRP) certification is highly desired.

• Experience interacting with patients in a HIPAA-regulated setting.

• Familiarity with Good Clinical Practice (GCP) and relevant regulatory requirements.

• Preferred medical and scientific knowledge.

• Proficient in trial management and clinical research.

• In-depth knowledge of FDA regulations and GCP guidelines.

• Proficiency in MS Office and Google Suite applications.

• Expertise in proprietary software.

• Ability to communicate effectively in English, both verbally and in writing.

• Capacity to collaborate with cross-functional team members.

• Ability to operate effectively in a decentralized team environment.

• May require extended or unusual working hours based on research needs and business requirements.

🏝️ Benefits

• Opportunity to transition to Full Time after 6 months.

• Up to 20% travel as necessary for project team meetings, client presentations, and other professional conferences.