Clinical Research Coordinator

General Notes

The Department of Surgery and Perioperative Care seeks to advance innovation from discovery to outcomes. The Department brings together clinical specialties, encouraging multidisciplinary collaboration. Specialties represented within the Department include anesthesiology, emergency medicine, general surgery, orthopedic surgery, otolaryngology, plastic surgery, and urology. The Department seeks a Clinical Research Coordinator who will work effectively with faculty Principal Investigators (PI) to ensure successful participation in key mission-aligned research studies.

Read more about the Department , our research , and our culture .

Work will take place in an office setting in the Health Discovery Building (HDB); some work will take place in clinical areas of the Health Transformation Building (HTB) and/or Dell Seton Medical Center at UT (DSMC-UT). This position is eligible for a hybrid Flexible Work Arrangement (FWA) (on-campus and remote work). On-campus presence will be required as determined by PI/ Manager and specific study needs. FWA arrangements are subject to manager approval and may shift due to changes in business needs. The remote location must have a reliable internet connection to support working remotely.

Finalist is required to complete Ascension Seton Research Affiliate application and UT Health UT Dell Medical School Employee Health. Part of this involves proof of and/or completion of immunizations for our affiliates approval.

Applicant must be authorized to work in the United States, without employer sponsorship, on a full-time basis for any employer.

The Clinical Research Coordinator manages daytoday study operations under the direction of a Principal Investigator (PI), ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance across startup, conduct, and closeout 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.

ESSENTIAL JOB FUNCTIONS:

Coordinates study startup and feasibility

Conducts prestudy feasibility and assists with budget/coverage analysis inputs and study calendars.

Prepares startup packages, facilitates siteinitiation, and implements IRBapproved 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 prescreening tests.

Plans and conducts study visits

Schedules and executes protocolspecified assessments (e.g., vitals, ECGs, sample collection/processing) 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 reconsent 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 ICHGCP (E6) and U.S. regulations.

Oversees data quality and monitoring

Performs 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 communication

Liaises with sponsors/CRAs, clinics, and ancillary departments; prepares status updates.

Supports study budgets and research billing workflows with appropriate routing.

Conducts study closeout

Reconciles data, IP, and essential documents; archives records per retention requirements.

Facilitates final monitoring/closeout visits and records lessons learned.

Other Job Duties may apply as assigned

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 other duties as required.

KNOWLEDGE/SKILLS/ABILITIES

Managing and Measuring Work

Sets clear objectives, uses metrics to monitor progress, and holds self/others accountable for results.

Defines visit/metric KPIs (screenfail rate, query cycle time) for each protocol.

Implements trackers (e.g., screening logs, IP logs) and reviews weekly.

Escalates barriers early and reprioritizes tasks to hit enrollment and datalock timelines.

Functional/Technical Skills (Clinical Research Operations)

Possesses deep, handson expertise in ICHGCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.

Applies ICHGCP and FDA/IRB guidance to consent and AE reporting decisions.

Operates EDC/CTMS/EPIC research modules with high data accuracy.

Executes startup/closeout checklists without findings on monitoring

Interpersonal Savvy

• Relates 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 problemsolving with CRAs/monitors.
• Ability to communicate clearly, professionally, and effectively with peers, patients, and patient families by phone and in person, while handling sensitive and confidential information with discretion in delicate, formal, or urgent situations.
• Demonstrated ability to communicate effectively and professionally in written and verbal formats.

Decision Quality

• Makes timely, evidencebased decisions that balance participant safety, compliance, and operational flow.
• Determines reconsent 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 prestages labs/shipments.
• Sequences startup tasks (regulatory, training, order sets) to hit FPI dates.
• Buffers time for monitoring, query resolution, and safety updates.

Ethics and Values

• 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.
• Adapts to decentralized/remote monitoring processes.
• Implements revised ICHGCP (E6 R3) expectations into daily work.
• Ability to rapidly learn, adapt, and apply new information in a changing environment.
• Ability to rapidly learn, adapt, and apply new information in a changing environment.

Minimum Qualifications:

• Bachelors degree in health, life science, or related field; or equivalent combination of education and directly related clinical research experience.
• 3 years of clinical research coordination or closely related humansubjects research experience (screening/consent, visit coordination, data entry, IRB submissions).
• Ability to work comfortably in a clinical environment, including the operating room.
• Ability to adhere to established work schedules and maintain regular, reliable, and punctual attendance.
• Obtaining external partners' site-specific clinical privileges, such as immunizations, is required.
• Relevant education and experience may be substituted as appropriate.

Preferred Qualifications:

• Masters in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field.
• 1-2 years coordinating interventional trials (oncology, cardiology, neurology, or surgical), including specimen handling, IP accountability, and monitoring support.
• Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules.

LICENSES, REGISTRATIONS OR CERTIFICATION S

Required:

• Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules.

Preferred:

• Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules.

$53,464 + depending on qualifications

WORKING ENVIRONMENT/EQUIPMENT

Standard office equipment

Repetitive use of a keyboard

• Resume/CV

• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important 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.