Clinical Research Coordinator, Freeman Lab Full-time

Clinical Research Coordinator, Freeman Lab

The Clinical Research Coordinator manages day-to-day study operations under the direction of a Principal Investigator (PI), ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance across start-up, conduct, and close-out activities. Typical partnerships include investigators, research nurses, pharmacists, laboratory teams, radiology, billing/compliance, and sponsor/CRO monitors; the role commonly reports to a PI, Research Manager, or Clinical Research Operations lead.

This is a temporary position with an end date of one year from the start date, but may be renewable based upon availability of funding, work performance, and progress toward research goals.

Responsibilities:

Coordinates study start-up and feasibility

• Conducts pre-study feasibility and assists with budget/coverage analysis inputs and study calendars.
• Prepares start-up packages, facilitates site-initiation, and implements IRB-approved protocols/SOPs.
• Collaborates with pharmacy, lab, and radiology to establish workflows and order sets.

Recruits, screens, and consents participants

• Identifies candidates via chart review and referrals; applies inclusion/exclusion criteria.
• Obtains and documents informed consent consistent with FDA guidance and IRB requirements.
• Educates participants on study procedures, risks/benefits, and alternatives; coordinates pre-screening tests.

Plans and conducts study visits

• Schedules and executes protocol-specified assessments (e.g., vitals, ECGs, sample collection/processing) per competency and delegation.
• Documents source data contemporaneously (ALCOA/ALCOA+), and enters data into EDC/CTMS.
• Maintains investigational product (IP) accountability and coordinates shipments per sponsor SOPs.

Ensures participant safety and reporting

• Monitors participants for AEs/SAEs and reports per protocol, IRB, and FDA requirements.
• Implements re-consent and safety updates; escalates medical concerns to PI.
• Tracks protocol deviations and executes CAPAs to prevent recurrence.

Manages regulatory and ethics documentation

• Maintains regulatory binders/eTMF, version control for consents, and IRB correspondence.
• Submits amendments, safety letters (e.g., IND safety reports), and continuing reviews.
• Applies ICH-GCP (E6) and U.S. regulations.

Oversees data quality and monitoring

• Performs source data review/verification readiness; responds to sponsor/CRO queries.
• Supports onsite/remote monitoring and audits; implements quality checks.
• Maintains data confidentiality per HIPAA and institutional policies.

Coordinates site operations and stakeholder communication

• Liaises with sponsors/CRAs, clinics, and ancillary departments; prepares status updates.
• Supports study budgets and research billing workflows with appropriate routing.

Conducts study close-out

• Reconciles data, IP, and essential documents; archives records per retention requirements.
• Facilitates final monitoring/close-out visits and records lessons learned.

Marginal or Periodic Functions:

• Assists with protocol development, informed consent drafting, and recruitment materials.
• Participates in tumor boards, investigator meetings, and community outreach events related to studies.
• Trains new team members on study workflows, documentation standards, and GCP basics.
• Supports internal audits and readiness for regulatory inspections.
• Adheres to internal controls and reporting structure.
• Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIES

Managing and Measuring Work

• Sets clear objectives, uses metrics to monitor progress, and holds self/others accountable for results.
• Defines visit/metric KPIs (screen-fail rate, query cycle time) for each protocol.
• Implements trackers (e.g., screening logs, IP logs) and reviews weekly.
• Escalates barriers early and re-prioritizes tasks to hit enrollment and data-lock timelines.

Functional/Technical Skills (Clinical Research Operations)

• Possesses deep, hands-on expertise in ICH-GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.
• Applies ICH-GCP and FDA/IRB guidance to consent and AE reporting decisions.
• Operates EDC/CTMS/EPIC research modules with high data accuracy.
• Executes start-up/close-out checklists without findings on monitoring

Interpersonal Savvy

• Relates well at all levels; builds constructive relationships with participants, clinicians, and sponsors.
• Communicates complex study info in plain language to participants.
• Navigates clinic/OR/ancillary schedules to reduce participant burden.
• Facilitates collaborative problem-solving with CRAs/monitors.

Decision Quality

• Makes timely, evidence-based decisions that balance participant safety, compliance, and operational flow.
• Determines re-consent needs after amendments using regulatory criteria.
• Assesses AE/SAE reportability and initiates expedited reporting.
• Applies HIPAA pathways for data access (authorization/waiver/LDS).

Planning and Priority Setting

• Breaks work into actionable steps; anticipates dependencies and resources.
• Builds visit schedules aligned to windows and pre-stages labs/shipments.
• Sequences start-up tasks (regulatory, training, order sets) to hit FPI dates.
• Buffers time for monitoring, query resolution, and safety updates.

Ethics and Values

• Champions participant rights, data privacy, and integrity of the research record.
• Protects PHI via minimum necessary and proper authorizations/waivers.
• Avoids exculpatory language; ensures understandable consent.
• Documents contemporaneously (ALCOA+) and reports deviations.

Learning Agility

• Rapidly learns new indications, devices, and systems; translates learning into practice.
• Completes role-based training (ACRP/SOCRA/GCP) and shares updates.
• Adapts to decentralized/remote monitoring processes.
• Implements revised ICH-GCP (E6 R3) expectations into daily work.

Required Qualifications

• Bachelor's degree in a health, life science, or related field; or equivalent combination of education and directly related clinical research experience.
• 3 years of clinical research coordination or closely related human-subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).
• Relevant education and experience may be substituted as appropriate.

Preferred Qualifications

• Master's in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field.
• 1-2 years coordinating interventional trials (oncology, cardiology, neurology, or surgical), including specimen handling, IP accountability, and monitoring support.
• Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules.
• Current GCP training consistent with ICH-GCP E6 (R2/R3) and FDA/HHS regulations; institutional human subjects protection training.
• ACRP CCRC® (Certified Clinical Research Coordinator) – eligibility typically requires ~3,000 hours of verifiable clinical research experience.
• SOCRA C