Clinical Research Coordinator

Clinical Research Coordinator

The Department of Surgery and Perioperative Care seeks a Clinical Research Coordinator who will work effectively with faculty Principal Investigators (PI) to ensure successful participation in key mission-aligned research studies.

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 Worklife Screening process, part of this involves proof of and/or completion of immunizations for our affiliate's 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 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.

ESSENTIAL JOB FUNCTIONS:

• Coordinates study start-up and feasibility
• Recruits, screens, and consents participants
• Plans and conducts study visits
• Ensures participant safety and reporting
• Manages regulatory and ethics documentation
• Oversees data quality and monitoring
• Coordinates site operations and stakeholder communication
• Conducts study close-out

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 (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.

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.
• 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.
• 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, evidence-based 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 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 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 ICH-GCP (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.

EDUCATION & EXPERIENCE Minimum Qualifications:

Bachelor's 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 human-subjects 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:

• Master's 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 CERTIFICATIONS

• Required: None
• Preferred: Current GCP training consistent with ICH-GCP E6 (R2/R3) and FDA/HHS regulations; institutional human subjects protection training.

Salary Range

$53,464 + depending on qualifications

WORKING ENVIRONMENT/EQUIPMENT

· Standard office equipment

· Repetitive use of a keyboard

Required Materials

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