Position: Clinical Research Manager
Location: St. Paul, Minnesota
Duration: 3 -12 month Contract to Hire
The Clinical Research Manager is responsible for managing daily operations for the Critical Care Research Center (CCRC) at a large hospital in downtown St. Paul. The Center oversees all research activities for the Emergency Medical Services department, the Emergency Department, the Burn Center, the Surgical Intensive Care Unit, the Adult and Pediatric Level 1 Trauma programs, and the Hospital Medicine program.
This individual will work collaboratively with the CCRC director and research staff to develop and implement new investigator-initiated and industry sponsored trials. This position will manage and supervise the daily work of nine CCRC clinical intern staff and six on-call enrollment specialists. A primary job function is to develop and maintain effective working relationships with clinical staff, as well as applicable regulatory bodies. This individual may assist in data analysis, scientific manuscript preparation, submission, and grant writing.
Major Job Duties
- Identifies and leads the implementation of potential clinical research projects within the Critical Care Research Center
- Reviews clinical trial protocols for implementation; assures applicable confidentiality agreements and other documents are appropriate collected and filed
- Manages all clinical trials activities conducted within the CCRC
- Manages entire CCRC project load, ensuring projects are meeting predefined timelines. Ensures all projects are conducted under Good Clinical Practices (GCP) and inline with applicable regulations and oversight entities and CCRC SOP documents
- Directly supervises and leads CCRC research staff
- Responsible for assisting with hiring process to include interviewing and providing input into hiring decision with CCRC director
- Assists CCRC Director with internal and external marketing efforts.
- Bachelor’s degree in health-related field; Master’s degree in public health, clinical research, or health administration preferred.
- Minimum of 3 years of clinical research experience.
- Knowledge of and ability to adhere to good clinical practices (GCP)
- Responsible for clinical site management duties, including oversight of site initiation activities, regulatory file management, patient recruitment, data acquisition and transfer, data analysis, manuscript preparation, and site closeout
- Serves as the primary liaison between sponsor research staff, institutional review boards, and internal patient care departments for study implementation and conduct
- Ability to develop and oversee multiple project plans, including clinical trials budget development
- Manages clinical research staff
- Knowledge of statistical methodology and experimental design; able to assist in the development of clinical investigational plans
- Proven process/project management experience; ability to objectively evaluate effectiveness of current practices; where appropriate, implement change within the organization.
- Clinical research professional certification preferred (ACRP or SoCRA)
- Certification/licensure as a health-care professional (EMT-B, EMT-P, emergency/critical care RN, or PA) strongly desired.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.