Clinical Research Coordinator I, Lab Trivedi

UT Southwestern Medical Center•Dallas, TX

About The Position

Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.

Requirements

Bachelor's Degree or higher degree in medical or science related field
1 year of clinical research experience
Experience in both clinical and research study settings
Ability to work within an interdisciplinary team
Strong written and oral communication skills
Experience with Microsoft Office Suite
Strong organizational skills
Minimum of 2 years of experience working directly with participants/patients in clinical research studies.
Ability to perform phlebotomy
Experience working with human tissue (including plasma, serum, and urine) specimens.

Nice To Haves

Experience working in Redcap is preferred.
(BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements.
(CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements.
ACRP or SOCRA certification a plus

Responsibilities

Direct interaction with clinical research participants enrolled in RAD/D2K (and possibly to include other studies)
Coordination of study procedures, activities, and payments
Collection of longitudinal study data and ensuring quality control of clinical research data
Overseeing patient retention
Supporting IRB maintenance and drafting of manuscripts and/or funding proposals
May be involved in sample collecting and processing
Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person.
Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies
Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI.
When outside of protocol, presents evidence and provides options (within scope of protocol) to PI.
Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process
Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools
Assist in developing and implementing research studies to include writing clinical research protocols.
Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work
Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars).
May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department.
Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
Review research study protocols to ensure feasibility
Assist in developing website or other social media for marketing/recruiting of clinical research study
Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems
Maintain subject level documentation
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% 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
healthcare
PTO
paid holidays
on-site childcare
wage, merit increases