JOB SUMMARY

The Simmons Cancer Center is seeking a Clinical Research Coordinator Lead to join their clinical research team. In this role, you will not have patient contact, rather, you will perform regulatory administration duties, such as regulatory submissions, budget drafting and negotiations, and regulatory study maintenance. If you enjoy a challenging, fast-paced environment and value working in a collaborative setting where you are valued as a team member, this is the position for you. As our ideal candidate, you have experience with clinical trials, in particular oncology research and clinical trial budget experience.
The Lead Clinical Research Coordinator will be responsible for a multitude of functions, including the listed job duties below:

EXPERIENCE AND EDUCATION

Required
Education
Bachelor’s Degree in medical or science related field
Experience
4 years of clinical research experience with Bachelor’s Degree
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.
May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
Preferred
Licenses and Certifications
BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
CPR AED may be required based on research study protocols or affiliate location requirements.
ACRP of SOCRA certification a plus.

Maintains required subject documentation for each study protocol.
Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
Maintains and coordinates data collection information required for each study that may also include developing CRF’s (case report form) or data collection tools.
Assists in developing and implementing research studies, may include writing clinical research protocols.
Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
May provide supervision to other members of the research team as necessary.
May perform research billing activities, as needed, based on size of department (including linking patient calendars
Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
Coordinates data management and collection for national (larger/more complex) research studies.
Serves as lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
Provides in-service training to all study team members and communicates to involved groups.
Reviews research study protocols to ensure feasibility requirements of the study.
Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
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.