Clinical Research Coordinator (CRC)

Key Responsibilities

Study Coordination

• Coordinate assigned clinical research studies from site initiation through study closeout.
• Review and maintain familiarity with study protocols, informed consent forms, manuals, schedules of assessments, and study-specific procedures.
• Prepare for and coordinate screening, enrollment, randomization, treatment, and follow-up visits.
• Ensure all study procedures are completed within protocol-required timeframes.
• Maintain accurate study calendars, visit schedules, task lists, and patient follow-up.

Participant Management

• Pre-screen potential participants against study inclusion and exclusion criteria.
• Coordinate participant screening and enrollment activities.
• Conduct or assist with the informed consent process under the direction of the Principal Investigator.
• Educate participants regarding study expectations, visit requirements, and study procedures.
• Maintain regular communication with study participants and help promote participant retention.
• Coordinate transportation, appointment reminders, and other participant logistics when applicable.
• Document participant interactions accurately and contemporaneously.

Clinical Study Visits

• Conduct protocol-required study visits within the coordinator's scope of practice and training.
• Obtain and document vital signs, medical history, concomitant medications, and other protocol-required information.
• Perform or coordinate ECGs, phlebotomy, specimen collection, processing, packaging, and shipment when applicable and appropriately trained.
• Administer questionnaires, scales, diaries, and other study assessments as required by the protocol.
• Coordinate study-related procedures with investigators, laboratories, pharmacies, imaging facilities, and outside medical providers.

Source Documentation & Data Entry

• Maintain complete, accurate, attributable, legible, contemporaneous, original, and accurate source documentation.
• Enter study data into Electronic Data Capture (EDC) systems accurately and within required timelines.
• Review source documents and electronic case report forms for completeness and consistency.
• Respond promptly to sponsor and CRO data queries.
• Maintain study-specific logs, including screening, enrollment, delegation, training, temperature, and investigational product logs as applicable.

Safety Reporting

• Identify and document adverse events and serious adverse events in accordance with study requirements.
• Promptly communicate safety information to the Principal Investigator.
• Assist with sponsor, CRO, IRB, and regulatory reporting of safety events within required timelines.
• Maintain appropriate documentation of adverse event follow-up.

Regulatory & Compliance

• Conduct studies in compliance with study protocols, ICH Good Clinical Practice (GCP), FDA regulations, IRB requirements, sponsor/CRO requirements, and site standard operating procedures.
• Assist with maintaining complete and audit-ready regulatory and study files.
• Ensure required training documentation and delegation records remain current.
• Report protocol deviations appropriately and assist with corrective and preventive actions when necessary.

Sponsor & Monitor Communication

• Serve as a primary operational contact for assigned studies.
• Communicate professionally with sponsors, CROs, monitors, investigators, laboratories, vendors, and other study partners.
• Prepare for and participate in site qualification visits, site initiation visits, interim monitoring visits, remote monitoring visits, closeout visits, sponsor audits, and regulatory inspections.
• Resolve monitoring findings and follow-up items within required timelines.

Investigational Product & Study Supplies

• Coordinate investigational product accountability and storage when delegated and appropriately trained.
• Maintain study supplies and ensure required materials are available for scheduled visits.
• Monitor expiration dates and storage requirements.
• Coordinate receipt, inventory, return, or destruction of study materials as applicable.

Recruitment Support

• Work closely with recruitment staff to identify potentially eligible participants.
• Review pre-screening information and determine whether candidates should proceed to formal screening.
• Contact potential participants and provide study information as appropriate.
• Help maintain screening and enrollment goals while ensuring that eligibility decisions remain based strictly on protocol requirements.

Qualifications

Required

• High school diploma or equivalent.
• Strong organizational and time-management skills.
• Excellent attention to detail.
• Strong verbal and written communication skills.
• Comfortable interacting with patients in a professional and compassionate manner.
• Ability to manage multiple priorities and studies simultaneously.
• Basic proficiency with computers, electronic medical records, and web-based systems.
• Ability to maintain confidentiality and handle protected health information appropriately.
• Ability to work independently while collaborating effectively with investigators and the research team.

Preferred

• Associate's or Bachelor's degree in healthcare, life sciences, nursing, public health, or a related field.
• Previous clinical research experience.
• Previous experience as a Clinical Research Coordinator, Research Assistant, Medical Assistant, or similar healthcare role.
• Experience using EDC, CTMS, eSource, ePRO, IWRS/IRT, or clinical trial management systems.
• Knowledge of FDA regulations and ICH-GCP.
• Current GCP certification.
• ACRP or SOCRA certification is a plus.
• Phlebotomy and ECG experience is a plus.

Skills & Competencies

• Exceptional attention to detail
• Accountability and reliability
• Strong follow-through
• Ability to prioritize competing deadlines
• Professional communication
• Patient-centered service
• Critical thinking and problem solving
• Ability to learn complex protocols quickly
• Strong documentation practices
• Comfort working in a fast-paced clinical research environment
• Ability to accept feedback and promptly correct deficiencies
• Commitment to regulatory compliance and research participant safety

Physical Requirements

• Extended periods of sitting and computer use
• Standing or walking during participant visits
• Handling laboratory specimens
• Lifting or moving study supplies
• Occasional early morning, evening, or weekend visits based on study schedules