The posting
We are seeking a highly organized, detail-oriented Clinical Research Coordinator (CRC) to support the successful conduct of clinical research studies at our site.
The Clinical Research Coordinator will be responsible for coordinating day-to-day study activities from study start-up through closeout, ensuring that clinical trials are conducted safely, efficiently, and in accordance with the study protocol, Good Clinical Practice (GCP), applicable regulations, and site standard operating procedures. The ideal candidate is dependable, comfortable working directly with patients and investigators, able to manage multiple studies simultaneously, and takes ownership of study timelines, documentation, and follow-up.
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
- Institutional Review Board (IRB) requirements
- Sponsor/CRO requirements
- 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: The successful candidate should demonstrate:
- 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: Depending on study requirements, the position may involve:
- 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
Typical schedule is [Monday–Friday, 8am - 5pm], although flexibility may occasionally be required for protocol-specific visits, participant scheduling, monitoring visits, or study deadlines.
