Clinical Research Associate I

Supports Site Monitoring Activities Assists senior CRAs with preparation for qualification, initiation, monitoring, and close-out visits.Participates in remote/in-person visits in a shadowing or support capacity.Conducts supervised source data review (SDR) and basic source data verification (SDV), prioritizing accuracy.Drafts or updates visit documentation (e.g., follow-up notes) for senior review.Assists with Data Quality and Query Support Conducts chart reviews and basic checks for completeness, accuracy, and consistency under supervision. Tracks and helps resolve queries with site staff per guidance from senior CRAs or data management.Reviews essential data listings to identify missing data or discrepancies for escalation.Supports Essential Document Management (TMF/ISF)Assists in collecting, uploading, organizing, and tracking essential regulatory documents.Conducts supervised ISF/TMF quality checks for version control and completeness.Prepares document packets for monitoring visits and audits for senior review.Aids in Participant Safety and Compliance Verification Performs preliminary checks of consent documentation for version alignment under oversightReviews AE/SAE listings and documents for completeness and flags issues to senior CRAs. Confirms eligibility criteria alignment during chart review, escalating uncertaintiesContributes to Study Start-up and Training Activities Assists with feasibility and site assessment documentation.Prepares training materials and trackers for protocol, GCP, and site-level instructions.Schedules meetings and maintains study training logs.Maintains Study Trackers, Systems and Communication Updates CTMS, EDC task lists, issue logs, and monitoring visit calendars.Prepares routine status updates for senior CRAs or PMs.Communicates site needs, questions, and status updates in a timely manner.Supports Investigational Product (IP) DocumentationPrepares IP accountability forms and checklists for monitoring visits.Assists senior CRAs in reviewing pharmacy logs and storage records.Supports Audit and Inspection Readiness Assists with document retrieval and basic pre-audit file checks.Participates in CAPA action tracking managed by senior team members.Perform other related duties as assigned. MARGINAL OR PERIODIC FUNCTIONS:Assists with centralized data review activities for risk-based monitoring.Participates in co-monitoring visits and retraining activities as assigned. Provides support for SOP updates, toolkit revisions, or CAPA documentation as directed.Coordinates with vendors (IVRS/IWRS, central labs, eCOA) on minor document or data requests.Adheres to internal controls and reporting structure.Performs related duties as required.KNOWLEDGE/SKILLS/ABILITIESAttention to DetailProduces accurate work; catches errors early; maintains documentation precision.Detects data/document inconsistencies during supervised SDR/SDV.Ensures version control when preparing essential documents.Carefully follows checklists and monitoring task guides.Learning AgilityLearns quickly; open to feedback; applies new knowledge rapidly.Incorporates GCP and SOP feedback into work product.Adapts to evolving monitoring tools (EDC, CTMS).Asks clarifying questions early to avoid quality issues.Planning and OrganizingPlans tasks effectively; structures work; anticipates workload steps.Prepares monitoring visit files ahead of deadlines.Maintains up-to-date trackers for action items and study progress.Prioritizes high-risk data checks when instructed.Problem SolvingUses structured approaches to understand and escalate issues.Identifies root causes behind repeated documentation errors.Distinguishes urgent vs. non-urgent data issues.Brings potential risks to senior staff promptly.Following Instructions / SOP AdherenceStrictly adheres to processes; avoids unauthorized deviations.Follows monitoring plans and SOPs exactly as written.Documents tasks only within approved systems.Escalates uncertainty instead of making independent decisions.I terpersonal SavvyWorks effectively with site teams, CRAs, and study staff.Communicates respectfully with CRCs and PI staff.Receives feedback professionally.Adapts communication style to various stakeholders.Written CommunicationProduces clear, concise documentation aligned with GCP expectations.Drafts clear visit notes and status updates.Writes concise query explanations.Ensures accuracy before submitting documentation for review.EDUCATION and EXPERIENCEMINIMUM QUALIFICATIONS:Requires a Bachelor's Degree in life sciences, nursing, public health or a related field.Basic understanding of GCP/Human Subjects ProtectionDemonstrated ability to follow SOPs, maintain accuracy, and learn quickly.Relevant education and experience may be substituted as appropriatePREFERRED QUALIFICATIONS:Bachelor's Degree in life sciences, nursing, public health or a related field with at least 1 year of experience in clinical research support (CTA, CRC assistant, research intern). Experience with EDC/CTMS systems Familiarity with risk-based monitoring concepts.LICENSES, REGISTRATIONS OR CERTIFICATIONSREQUIRED: NonePREFERRED:GCP training (ICH E6) and institutional human subjects training upon hire.IATA certification if handling/shipping specimens (applies only if assigned).ACRP (CCRA, ACRP-CP) or SOCRA CCRP certification (not required at hire).Salary Range$40,623 + depending on qualificationsWORKING ENVIRONMENT/EQUIPMENT Standard office equipment Repetitive use of a keyboardRequired MaterialsResume/CV3 work references with their contact information; at least one reference should be from a supervisorLetter of interestImportantfor 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 thatALLRequired 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 questionspresented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.