Lead Clinical Research Coordinator – Simmons Cancer Center

WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you’ll discover a culture of teamwork, professionalism, and a rewarding career!

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:

Regulatory Functions:

• Manage new study submissions assigned as a Regulatory Assistant/Regulatory Associate.
• Manage study maintenance for all assigned clinical trials including study modifications, continuing reviews, internal/external interim monitoring visits, internal/external audits of assigned studies, FDA compliance and submissions for investigator-sponsored trials in which we are the IND holders, study closures, etc.
• Maintain essential regulatory documents and filing.
• Manage study termination process for assigned clinical trials.
• Consistently meet regulatory deadlines and goals for submissions.
• Complete and maintain RCR registration process for investigators as assigned.

Time to Activation Functions:

• Provide oversight of study status throughout the process from receipt of the study to activation.
• Manage clinical trial budget negotiations and approvals.
• Assist with feasibility budgets for investigator-initiated trials within the disease oriented team.
• Work with ancillary departments for completing clinical trial processes related to studies under SCCC CRO.

General Functions:

• Maintains working relationships with faculty and academic departments across UTSW to help oversee the conduct of hematology/oncology clinical trials as assigned.
• Work with DOT Managers to prioritize study submissions and manage regulatory monitoring visits and audits.
• Attend all meetings and trainings as they relate to the day-to-day duties of the job.
• Update all applicable databases/spreadsheets.

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• 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
• Learn more about these and other UTSW employee benefits!

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. 

JOB DUTIES

• 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.

SECURITY AND EEO STATEMENT
Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 113.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position.

EEO Statement
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.