Clinical Research Coordinator

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 internal audits and readiness for regulatory inspections.
• •Adheres to internal controls and reporting structure.
• •Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIES

Willing to work on weekends/after normal business hours

Managing and Measuring Work

• •Sets 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.
• •Possesses excellent time management and organizational skills, with excellent attention to detail

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 monitoring

Interpersonal Savvy

• •Relates well at all levels; builds constructive relationships with participants, clinicians, and sponsors.
• •Ability to work professionally and tactfully with an interdisciplinary team of clinicians, fellows, and other research associates
• •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.
• •Comfortable interacting with participants living with severe mental illness

Decision Quality

• •Makes 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 Setting

• •Breaks 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 Compliance

• •Champions 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 Agility

• •Rapidly 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.

EDUCATION & EXPERIENCE

MINIMUM QUALIFICATIONS:

Requires a Bachelor's Degree in health, psychology, neuroscience, life science, or a related field with at least 3 year(s) of experience in clinical research coordination or closely related human‑subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).

• •Relevant education and experience may be substituted as appropriate.
• •Phlebotomy and ECG competencies.

Relevant education and experience may be substituted as appropriate.

According to Executive Order No. GA-48 of the State of Texas: for all positions that research, work on, or have access to critical infrastructure as defined in Section 117.001(2), Business and Commerce Code, it is required that both candidates for employment and employees have the ability to maintain the security or integrity of the infrastructure.

PREFERRED QUALIFICATIONS:

Master's Degree in nursing, allied health, psychology, neuroscience, public