Clinical Research Coordinator, Freeman Lab

Job Posting Title:Clinical Research Coordinator, Freeman Lab-Hiring Department:Department of Neurology-Position Open To:All Applicants-Weekly Scheduled Hours:40-FLSA Status:Exempt from FLSA-Earliest Start Date:Immediately-Position Duration:Expected to Continue Until May 01, 2027-Location:AUSTIN, TX-Job Details:PurposeThe Clinical Research Coordinator independently 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.ResponsibilitiesCoordinates 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 independently executes protocol-specified assessments (e.g., vitals, ECGs, sample collection/processing) per competency and delegation.Documents source data contemporaneously (ALCOA/ALCOA+), and ensures timely and accurate entry 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 communicationCoordinates and drives site operations across multiple studies with a high degree of accountability.Liaises 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 FunctionsAssists 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 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.Takes ownership of study timelines and deliverables with minimal oversight.Functional / Technical Skills (Clinical Research Operations)Possesses 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 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 reporting.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.Required QualificationsBachelor’s degree in a health, life science, or related field; or equivalent combination of education and directly related clinical research experience.Three (3) years of clinical research coordination or closely related human-subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).Demonstrated ability to manage multiple studies simultaneously with strong organization, accountability, and attention to detail.Relevant education and experience may be substituted as appropriate.Preferred QualificationsMaster’s in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field.Experience coordinating interventional clinical trials (oncology, cardiology, neurology, or surgical), including specimen handling, IP accountability, and monitoring support.Experience with EDC/CTMS and Epic research modules.Current GCP training consistent with ICH-GCP E6 (R2/R3) and FDA/HHS regulations.ACRP CCRC or SOCRA CCRP certification (or eligibility).Phlebotomy and ECG competencies, if required by study protocols.Salary Range$53,454 + depending on qualificationsWorking ConditionsPrimarily onsite role based in Austin, Texas.Typical clinical and office environment with frequent interaction in patient care and research settings.Work may involve coordination across clinics, laboratories, and hospital environments.Frequent use of a computer and electronic systems for documentation and data entry.May require schedule flexibility to support study visits and participant availability.Required MaterialsResume/CV3 work references with their contact information; at least one reference should be from a supervisorLetter of interestImportant for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.-Employment Eligibility:Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.-Retirement Plan Eligibility:The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.-Background Checks:A criminal history background check will be required for finalist(s) under consideration for this position.-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, or veteran status in employment, educational programs and activities, and admissions.-Pay Transparency:The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.-Employment Eligibility Verification:If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.-E-Verify:The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:E-Verify Poster (English and Spanish) [PDF]Right to Work Poster (English) [PDF]Right to Work Poster (Spanish) [PDF]-Compliance:Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701. #J-18808-Ljbffr