Clinical Research Manager, Simmons Cancer Center

UT Southwestern Medical Center • Dallas, TX

9d

About The Position

The Clinical Research Manager is responsible for the overall Neuro-Oncology Disease Oriented Team (DOT) research functions and includes working closely with DOT leaders to manage pipeline of studies, organizing monthly DOT meetings and assisting in the development of investigator-initiated trials. Additionally, manages coordination of staff, which includes hiring, initial training and onboarding, continuing education and development as well as performance management. This role also provides oversight of study start up activities, which includes managing the progress of new trials through regulatory approval, contract and budgeting as well as ancillary reviews. Additional responsibilities include general study management activities such as monitoring accrual, facilitating continuing review, maintain relationships with sponsor, pharmacy, ancillary and clinic staff and playing an active role in quality assurance by participating in internal audits and implementation of corrective actions as required. This role also requires the incumbent to maintain ability to function as a study coordinator when required.

Requirements

• Bachelor's Degree in science, social science, business, health-related (including nursing) field or
• Master's Degree in science, social science, business, or health-related (including nursing) field or
• PhD or equivalent in science, social science, business, or health-related (including nursing) field
• 6 years of related experience to include management experience with Bachelor's Degree or
• 4 years of related experience to include management experience with Master's Degree or
• 3 years of related experience to include management experience with PhD.
• (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.

Nice To Haves

• 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.
• Previous Neuro-Oncology Coordinating experience
• Previous Study start up experience

Responsibilities

• Reviews proposed new research studies and determines projects to implement; negotiates budget and contract issues; initiates regulatory activities; oversees preparation of necessary project summaries, consent forms, etc. for IRB; oversees compliance with all regulatory requirements.
• Oversees on-going research studies and quality assurance measures, developing criteria where necessary; negotiates favorable agreements with laboratories and collaborators on campus; monitors profitability of research studies; renegotiates contracts, supplements, etc. as needed.
• Directs financial oversight and management of clinical research unit; ensures invoicing is accurate and sponsor payments are received; ensures appropriateness of expenditures from various funding sources available to clinical research unit.
• Participates in selection process of clinical research unit staff; provides training to research, financial, laboratory, and administrative staff; evaluates staff performance and implements measures necessary to maintain quality performance and results; participates in training, development, and/or disciplinary measures; assesses policies and procedures to ensure optimal operation of clinical research unit.
• Identifies potential sponsors for clinical research unit; develops and oversees marketing strategies.
• Initiates and maintains collaborative relationships between clinical research unit and basic science facilities.
• Designs, executes, and maintains effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
• Ensures compliance with applicable laws, regulations, policies, and procedures.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees