Supervisor Clinical Research, Pediatrics

UT Southwestern Medical Center•Dallas, TX

15h

About The Position

Works under the direction of an Investigator(s) with limited supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Provides supervision to a team engaged in the execution of multiple, complex research protocols. Research Supervisor, PHOCUS Team Project Leadership · Oversee the planning, implementation, and management of Investigator Initiated Trials, ensuring alignment with defined scientific objectives and allocated effort, working directly with study Principal Investigators (PI) Contracts and Agreements Management Oversee the full lifecycle of all existing contractual agreements, including DUAs, CTAs, CDAs, and subawards, ensuring compliance with institutional, sponsor, and regulatory requirements. Maintain a centralized tracking system for contracts, including key milestones, renewal deadlines, and dependencies that may impact study timelines. Proactively initiate and execute new contracts with external vendors, participating sites, and collaborators for prospective interventional and observational trials. Maintain accurate financial reporting including IDR approval, PO verification, and any Peoplesoft approvals. Study Start-Up and Multisite Regulatory Oversight (single IRB Management) Lead study start-up and longitudinal regulatory management for multisite protocols operating under a single IRB (sIRB) model. Prepare and submit new protocol applications for local and multisite studies, serving as the primary regulatory point of contact for the study team. Coordinate completion of reliance agreements, waivers, and associated institutional requirements necessary for sIRB participation. Manage initial regulatory submissions for additional participating sites, including collection and review of site-specific documents, coordination with external regulatory teams, and tracking approval status. Oversee submission and ongoing management of amendments, continuing reviews, reportable events, and study closures at the lead site and across all participating sites. Track, document, and manage protocol deviations (minor and major), ensuring appropriate reporting, corrective actions, and communication with investigators and regulatory bodies. Project Coordination and Process Development Take initiative to independently identify, develop, and refine regulatory and operational workflows for multisite studies, particularly in areas where processes are evolving or not yet standardized. Anticipate regulatory and contractual challenges and proactively develop solutions to minimize delays. Create and maintain study-level tracking tools, regulatory binders, and dashboards to support high-volume, complex trial portfolios. Coordinate IND objectives and timelines. Coordinate study teams and manage research project timelines to ensure research trials are completed within the specified timeline. Manage data and safety monitoring board (DSMB) for applicable studies, including DSMB formation, maintenance, DSMB meeting schedules, and managing follow-up actions. Data Management · Validate and oversee the integrity of collected data; manage and monitor data entry processes to ensure accuracy and completeness · Perform data cleaning and quality control procedures; and run, oversee, and generate data reports from the electronic data capture system to support manuscripts, abstracts, and grant applications. · Conduct analyses as appropriate under the PI guidance and author clear, timely reports to communicate findings to investigators and other stakeholders. Study Visit Coordination and Conduct · When applicable, support and conduct study visits in accordance with approved protocols, including coordination of visit logistics and completion of study procedures. · Ensure adherence to protocol requirements, regulatory standards, and institutional policies during participant-facing activities, and coordinate closely with investigators and clinical teams to maintain high-quality study execution. Communication · Communicate professionally and effectively with local investigators, institutional regulatory offices, external collaborating sites, sponsors, and vendors. Serve as a reliable liaison between the study team and external partners, ensuring clarity around timelines, responsibilities, and regulatory expectations. Support investigators by translating regulatory requirements into clear, actionable steps that facilitate study conduct without compromising compliance. Required Skills and Attributes Exceptional organizational skills with the ability to manage multiple studies, deadlines, and collaborators simultaneously in a fast-paced academic research environment. Demonstrated attention to detail and accuracy, particularly in regulatory documentation, contracts, and compliance tracking. Strong initiative and problem-solving mindset, with comfort navigating ambiguity and independently learning new systems or regulations. Excellent written and verbal communication skills, with the ability to represent the research program professionally to internal and external partners. Ability to work collaboratively across disciplines while maintaining accountability for regulatory and programmatic deliverables. Experience: 2+ years of study coordination and project management experience A minimum of two current references will be required.

Requirements

Exceptional organizational skills with the ability to manage multiple studies, deadlines, and collaborators simultaneously in a fast-paced academic research environment.
Demonstrated attention to detail and accuracy, particularly in regulatory documentation, contracts, and compliance tracking.
Strong initiative and problem-solving mindset, with comfort navigating ambiguity and independently learning new systems or regulations.
Excellent written and verbal communication skills, with the ability to represent the research program professionally to internal and external partners.
Ability to work collaboratively across disciplines while maintaining accountability for regulatory and programmatic deliverables.
Experience: 2+ years of study coordination and project management experience
A minimum of two current references will be required.
Bachelor's Degree in medical or science related field.
5 years of clinical research experience.
May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

Nice To Haves

(BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
(CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
ACRP or SOCRA certification a plus.
Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.

Responsibilities

Oversee the planning, implementation, and management of Investigator Initiated Trials, ensuring alignment with defined scientific objectives and allocated effort, working directly with study Principal Investigators (PI)
Oversee the full lifecycle of all existing contractual agreements, including DUAs, CTAs, CDAs, and subawards, ensuring compliance with institutional, sponsor, and regulatory requirements.
Maintain a centralized tracking system for contracts, including key milestones, renewal deadlines, and dependencies that may impact study timelines.
Proactively initiate and execute new contracts with external vendors, participating sites, and collaborators for prospective interventional and observational trials.
Maintain accurate financial reporting including IDR approval, PO verification, and any Peoplesoft approvals.
Lead study start-up and longitudinal regulatory management for multisite protocols operating under a single IRB (sIRB) model.
Prepare and submit new protocol applications for local and multisite studies, serving as the primary regulatory point of contact for the study team.
Coordinate completion of reliance agreements, waivers, and associated institutional requirements necessary for sIRB participation.
Manage initial regulatory submissions for additional participating sites, including collection and review of site-specific documents, coordination with external regulatory teams, and tracking approval status.
Oversee submission and ongoing management of amendments, continuing reviews, reportable events, and study closures at the lead site and across all participating sites.
Track, document, and manage protocol deviations (minor and major), ensuring appropriate reporting, corrective actions, and communication with investigators and regulatory bodies.
Take initiative to independently identify, develop, and refine regulatory and operational workflows for multisite studies, particularly in areas where processes are evolving or not yet standardized.
Anticipate regulatory and contractual challenges and proactively develop solutions to minimize delays.
Create and maintain study-level tracking tools, regulatory binders, and dashboards to support high-volume, complex trial portfolios.
Coordinate IND objectives and timelines.
Coordinate study teams and manage research project timelines to ensure research trials are completed within the specified timeline.
Manage data and safety monitoring board (DSMB) for applicable studies, including DSMB formation, maintenance, DSMB meeting schedules, and managing follow-up actions.
Validate and oversee the integrity of collected data; manage and monitor data entry processes to ensure accuracy and completeness
Perform data cleaning and quality control procedures; and run, oversee, and generate data reports from the electronic data capture system to support manuscripts, abstracts, and grant applications.
Conduct analyses as appropriate under the PI guidance and author clear, timely reports to communicate findings to investigators and other stakeholders.
When applicable, support and conduct study visits in accordance with approved protocols, including coordination of visit logistics and completion of study procedures.
Ensure adherence to protocol requirements, regulatory standards, and institutional policies during participant-facing activities, and coordinate closely with investigators and clinical teams to maintain high-quality study execution.
Communicate professionally and effectively with local investigators, institutional regulatory offices, external collaborating sites, sponsors, and vendors.
Serve as a reliable liaison between the study team and external partners, ensuring clarity around timelines, responsibilities, and regulatory expectations.
Support investigators by translating regulatory requirements into clear, actionable steps that facilitate study conduct without compromising compliance.
Assists with the daily operations for the research unit, to include but not limited to staffing, protocol management, budgeting, and regulatory requirements.
May assist in development of study design, implementation, and administration for new studies ensuring compliance with HRPP/IRB requirements, Federal/State regulations, and grant and/or contract parameters.
Assists with monitoring and oversight of active clinical research protocols in accordance with internal policies, federal and state regulations, and University policies.
Oversees and coordinates data collection and assures accuracy and timely submission to sponsors and/or external
Oversees and coordinates the scheduling and efficient usage of research facilities.
Performs research billing activities (including linking patient calendars) and oversees the financial status of the research protocols for the team
Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards
Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing, or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
Performs other duties as assigned.

Benefits

PPO medical plan, available day one at no cost for full-time employee-only coverage
100%25 coverage for preventive healthcare-no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer

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