Overview:
The Research Study Coordinator is responsible for the execution and coordination of clinical trials within the clinic setting. This includes screening, enrollment, informed consent, subject follow-up, and ensuring protocol adherence across all study activities. The CRC works closely with investigators, clinical staff, and external sponsors to maintain compliance with FDA regulations, ICH-GCP guidelines, and institutional SOPs.

Responsibilities:

• Coordinate all aspects of assigned clinical studies from initiation to closeout.
• Lead recruitment, screening, enrollment, and patient retention of study participants per protocol.
• Administer informed consent process and ensure ongoing participant compliance.
• Collect, document, and maintain source data and case report forms accurately.
• Manage investigational product accountability and dispensing (if applicable).
• Monitor and document adverse events; escalate per protocol and regulatory requirements.
• Prepare and ship laboratory specimens in compliance with protocol and biosafety regulations.
• Liaise with sponsors, CROs, and study monitors for site visits and audits.
• Maintain regulatory documentation including IRB submissions, amendments, and deviation reports.
• Assist in preparing for audits and participate in sponsor or regulatory inspections.
• Support training and onboarding of new research team members (if applicable).
• Ensure study supplies, lab kits, and equipment are available and in working order.
• Adherence to compliance and completion of compliance training.
• All other related duties as assigned.

Qualifications:

• Associate’s degree in a health-related field required; Bachelor’s preferred.
• Minimum 1–2 years of clinical research experience preferred.
• Certification (SoCRA, ACRP) preferred or willing to obtain within 12 months.
• Phlebotomy experience preferred (if applicable by study protocol).
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial workflows.
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and EDC systems.
• Excellent communication and documentation skills.
• Demonstrated ability to prioritize tasks and manage time independently.
• Effective team collaborator; comfortable interacting with clinicians and patients.
• Detail-oriented and adaptable to fast-paced research environments.

Forefront will never request personal information, such as your social security number or banking information, via text or email. In addition, Forefront does not use external messaging applications such as WireApp or Skype to communicate with candidates. If you receive communication or requests of this nature, delete them.

• Coordinate all aspects of assigned clinical studies from initiation to closeout.
• Lead recruitment, screening, enrollment, and patient retention of study participants per protocol.
• Administer informed consent process and ensure ongoing participant compliance.
• Collect, document, and maintain source data and case report forms accurately.
• Manage investigational product accountability and dispensing (if applicable).
• Monitor and document adverse events; escalate per protocol and regulatory requirements.
• Prepare and ship laboratory specimens in compliance with protocol and biosafety regulations.
• Liaise with sponsors, CROs, and study monitors for site visits and audits.
• Maintain regulatory documentation including IRB submissions, amendments, and deviation reports.
• Assist in preparing for audits and participate in sponsor or regulatory inspections.
• Support training and onboarding of new research team members (if applicable).
• Ensure study supplies, lab kits, and equipment are available and in working order.
• Adherence to compliance and completion of compliance training.
• All other related duties as assigned