Clinical Research Coordinator II, Family and Community Medicine

UT Southwestern Medical Center • Dallas, TX

1d

About The Position

The Department of Family and Community Medicine at UT Southwestern Medical Center is seeking a Clinical Research Coordinator II to join their team. This role will support research led by Dr. Rebecca Eary and Dr. Amy Hughes, focusing on a randomized control trial to improve transitions from a pediatric survivorship program to an adult onco-primary care clinic. The study aims to determine if enhanced support and patient education from a nurse navigator improves attendance at an adult survivorship clinic visit. The position will also collaborate with investigators at UT Health Houston School of Public Health, including Dr. Aubree Shay. The ideal candidate will have research experience in primary care, cancer, cancer survivorship/onco-primary care, and/or clinical research. This is a 100% grant-funded position.

Requirements

• Bachelor's Degree in medical or science related field
• 2 years years 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.

Responsibilities

• Directly interacts with, and maintains records for, clinical research participants, remotely or in-person.
• Coordinates and schedules procedures as per research study.
• Recruits, screens, enrolls, consents, and follows research participants according to approved research protocols and applicable regulatory and institutional requirements.
• Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
• Maintains required subject documentation for each study protocol.
• Assists in developing and implementing research studies.
• Assists in developing website or other social media for marketing/recruiting for research studies.
• Reviews research study protocols to ensure feasibility requirements of the study.
• May assist in writing clinical research protocols.
• Coordinates and assists in regulatory and fiscal management and reporting duties.
• Coordinates regulatory documentation for research studies, including maintaining information and submitting reports and paperwork to internal and external institutions, and other University and hospital offices to ensure study requirements are met.
• Prepares protocols for Institutional Review Board (IRB) submission, and may submit amendments and continuing review documents.
• Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
• Identifies and documents protocol deviations, adverse events (AEs), serious adverse events (SAEs), and other reportable events and communicates and reports such events to the PI, IRB, study sponsor, and/or other applicable entities as required by the research protocol, institutional policies, or regulatory requirements.
• May assist the PI on the fiscal management of the trial including budget preparation.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• May assist with sponsor reporting, progress reports, study updates, and other sponsor-required documentation and deliverables.
• Conducts data collection activities.
• Maintains and coordinates data collection information required for studies, including developing case report forms or data collection tools.
• Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.
• Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• Is responsible for research data collection and utilizes REDCap, Epic electronic medical record (EMR), and/or other electronic databases and data management systems, as required by the assigned research study.
• Performs study team communication, training, and administrative tasks in aid of study coordination.
• Liaises between principal investigators, research team members, institutional offices, external collaborating institutions, sponsors, and other stakeholders to facilitate research activities and project coordination.
• May coordinate research activities across multiple departments, institutions, study sites, and external collaborating organizations.
• May supervise, train, orient, and provide guidance to learners, students, trainees, research coordinators, research assistants, and/or other study staff regarding research protocols, study procedures, data collection, and applicable regulatory requirements.
• May develop and maintain project timelines, study trackers, recruitment logs, data collection schedules, and other tools to monitor study progress and completion of project activities.
• May facilitate research team meetings, including coordinating meeting schedules, preparing agendas, documenting action items, and following up on assigned tasks.
• May assist with identifying and resolving operational issues, barriers to recruitment, data collection challenges, and other problems that may affect study progress or completion.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Provides in-service training to all study team members and communicates to involved groups.
• Performs other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level