Clinical Research Coordinator, Freeman Lab

Clinical Research Coordinator, Freeman Lab Location: Austin, TX Hours: Full‑time, 40 hours per week Overview 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. The position reports to a PI, Research Manager, or Clinical Research Operations lead and is temporary for one year with possible renewal. Responsibilities Coordinating study start‑up and feasibility: Conduct pre‑study feasibility and assist with budget/coverage analysis inputs and study calendars. Prepare start‑up packages, facilitate site‑initiation, and implement IRB‑approved protocols/SOPs. Collaborate with pharmacy, lab, and radiology to establish workflows and order sets. Recruiting, screening, and consenting participants: Identify candidates via chart review and referrals; apply inclusion/exclusion criteria. Obtain and document informed consent consistently with FDA guidance and IRB requirements. Educate participants on study procedures, risks/benefits, and alternatives; coordinate pre‑screening tests. Planning and conducting study visits: Schedule and execute protocol‑specified assessments such as vitals, ECGs, and sample collection/processing. Document source data contemporaneously (ALCOA/ALCOA+) and enter data into EDC/CTMS. Maintain investigational product accountability and coordinate shipments per sponsor SOPs. Ensuring participant safety and reporting: Monitor participants for adverse events (AE/SAE) and report per protocol, IRB, and FDA requirements. Implement re‑consent and safety updates; elevate medical concerns to the PI. Track protocol deviations and execute corrective and preventive actions to prevent recurrence. Managing regulatory and ethics documentation: Maintain regulatory binders/eTMF, version control for consents, and IRB correspondence. Submit amendments, safety letters, and continuing reviews. Apply ICH‑GCP (E6) and U.S. regulations. Overseeing data quality and monitoring: Perform source data review/verification readiness; respond to sponsor/CRO queries. Support onsite or remote monitoring and audits; implement quality checks. Maintain data confidentiality per HIPAA and institutional policies. Coordinating site operations and stakeholder communication: Liaise with sponsors/CRAs, clinics, and ancillary departments; prepare status updates. Support study budgets and research billing workflows with appropriate routing. Conducting study close‑out: Reconcile data, investigational product, and essential documents; archive records per retention requirements. Facilitate final monitoring/close‑out visits and record lessons learned. Marginal or periodic functions: Assist with protocol development, informed consent drafting, and recruitment materials. Participate in tumor boards, investigator meetings, and community outreach events related to studies. Train new team members on study workflows, documentation standards, and GCP basics. Support internal audits and readiness for regulatory inspections. Adhere to internal controls and reporting structure. Required Qualifications Bachelor’s degree in a health, life science, or related field; or equivalent combination of education and directly related clinical research experience. Three years of clinical research coordination or closely related human‑subjects research experience (screening/consent, visit coordination, data entry, IRB submissions). Preferred Qualifications Master’s degree in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field. One to two years coordinating interventional trials (oncology, cardiology, neurology, or surgical) with specimen handling, investigational product 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 verified clinical research experience. SOCRA CCRP® – eligibility via experience/education pathways (e.g., two years full‑time CRP experience). BLS/CPR if required by protocol or affiliate location. Salary $53,454 plus adjustment based on qualifications. Equal Opportunity Employer The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, veteran status, or any other characteristic in employment, educational programs, and activities, and admissions. Employment Eligibility Verification If hired, you will be required to complete the federal Employment Eligibility Verification I‑9 form and present acceptable documents to prove identity and authorization to work in the United States no later than the third day of employment. #J-18808-Ljbffr