Manager Clinical Trials; Hybrid; Radiology

Location

SAINT LOUIS, MO 63110

40

This position will be housed in the Department of Radiology, in the clinical research group of Dr. Richard Wahl. Mallinckrodt Institute of Radiology’s clinical theranostics program provides personalized medical management through targeted radiopharmaceutical diagnosis and therapy. The selected candidate will work collaboratively and directly with the Center for Clinical Theranostics Research (CCTR) managing radiopharmaceutical clinical trials led by Dr. Wahl. The relevant individual will also work on diagnostic imaging trials led by Dr.

Wahl, working with the Center for Clinical Imaging Research. The position is directly responsible for the supervision, oversight, training and education of research coordinators and may have direct interactions with commercial sponsors and, on occasion, patients. The position requires the ability to assess protocols for budgetary and logistical issues associated with the coordination and implementation of oncology radiopharmaceutical trials as well as regulatory issue.

Additional components of the position include regulatory submissions, finances, and leadership of clinical research staff.

Primary

Duties & Responsibilities:

Makes hiring and staffing decisions in the Functional Research Groups with input from the Administrative and Medical Directors of the Core. Orients and trains all staff in the Functional Research Groups, and assists in orienting new staff in the Regulatory and Protocol Development groups. Meets regularly with all staff, providing supervision and training. With the Administrative Director and Medical Director, strategically plans and implements plans for Functional Research Groups, including staffing (setting current and future a appropriate staff levels), education, adherence to federal regulations and standard operating procedures for ensuring quality data collection.

Provides feedback and performs annual performance evaluations for Research Coordinators with assistance from Senior Clinical Research Associates and the Administrative Director. Supports Senior Clinical Research Associate through initial performance improvement efforts and directs progressive performance management and disciplinary activities as required. Assesses new protocols for logistical and budgetary issues and creates a plan to address these. Creates budgets for new studies.

Assists with evaluating and entering studies into the database. Meets regularly with Administrative Director (at least weekly, but probably more often); represents Functional Research Groups at senior level meetings. Meets regularly with the oncologist to assess the progress and goals of the research program. Leads regular meetings with the study team and members of each clinical area to plan for the successful implementation of upcoming studies.

Oversees the daily research activities for Senior Research Coordinators including compliance with protocol criteria and adherence to federal regulations. Oversees daily protocol management activities of Senior Research Coordinators. Monitors collected data for accuracy of objective criteria. Facilitates accrual to high priority research studies. Oversees the quality assurance process for monitoring the collection of data for research, with assistance from the Quality Assurance and Safety Monitoring Committee (QASMC).

Performs other duties as assigned.

Job Location /

Working Conditions:

Normal office environment. Physical Effort:
Typically sitting at desk or table. Repetitive wrist, hand or finger movement (PC Typing). Equipment:
Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum…