Job Posting Title:
Clinical Research Coordinator ----
Hiring Department:
Department of Psychiatry ----
Position Open To:
All Applicants ----
Weekly Scheduled Hours:
40 ----
FLSA Status:
Exempt from FLSA ----
Earliest Start Date:
Immediately ----
Position Duration:
Expected to Continue Until Dec 31, 2027 ----
Location:
AUSTIN, TX ----
Job Details:
General Notes
Dell Medical School is seeking a Clinical Research Coordinator. This is a grant-funded position that has an end date of 12/31/27, renewable based upon availability of funding, work performance, and progress toward research goals. Flexible work hours (including weekend and/or after hours) to meet deadlines.
Purpose
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 equivalent. This role will serve in the Department of Psychiatry and Behavioral Sciences aiding in bipolar disorder research. Employee must be willing to work on weekends/after normal business hours to meet deadlines, when needed.
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, neuroimaging, neurocognitive assessments) 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 in a timely manner
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 investigator meetings, and community outreach events related to studies.
Trains new team members on study workflows, documentation standards, and GCP basics.
Supports…