Clinical Research Coordinator, Freeman Lab

:Coordinates study start-up and feasibilityConducts 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 participantsIdentifies 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 visitsSchedules 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 reportingMonitors 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 documentationMaintains 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 monitoringPerforms 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 communicationLiaises with sponsors/CRAs, clinics, and ancillary departments; prepares status updates.Supports study budgets and research billing workflows with appropriate routing.Conducts study close-outReconciles 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/ABILITIESManaging and Measuring WorkSets 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 monitoringInterpersonal SavvyRelates 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 QualityMakes 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 report ng.Applies HIPAA pathways for data access (authorization/waiver/LDS).Planning and Priority SettingBreaks 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 ValuesChampions 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 AgilityRapidly 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.