Clinical Research Project Manager

Job

376751

Location

Twin Cities

Job Family

Research

Full/Part Time

Full-Time

Regular/Temporary

Regular

Job Code

8354CP

Employee Class

Civil Service

About the Job

Position Overview

This role will manage studies led by the supervisor and PI, Dr. Sandra Japuntich. The primary purpose of this position is to manage a portfolio of human subjects research from concept to study closeout focused on tobacco cessation treatment development, effectiveness, and implementation. Duties are determined by protocol-specific requirements. These may include analyzing study feasibility, developing study specific materials, overseeing recruitment and enrollment of study subjects, overseeing study data collection, managing regulatory documents and required reporting, and supervising study staff.

The first task will be to serve as a project manager for a recently funded PCORI trial to test models to deliver tobacco use disorder treatment in community mental healthcare settings across 4 states. https://(Use the "Apply for this Job" box below).-care

Duties/Responsibilities
35%: Manages study protocol from concept to study closeout. Works collaboratively to analyze study feasibility, develop study specific materials, ensure that staff are trained on delegated tasks and responsibilities. Facilitates execution of protocol. Collaborates with research study staff (Investigators, Coordinators, etc.) to review the study protocol and develop the study budget to ensure that all relevant study costs have been included.

Ensures timely processing of all pre-award steps to avoid delays in starting trials. Compares protocol and contract documents for consistency. Acts as a liaison with the Sponsored Project Administration (SPA) department and academic department finance/administration to facilitate communications, ensure document submissions, and resolve any contract issues. Works to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants.

Works with post-award accountants to ensure accurate invoicing and contracting is completed.

35%: Executes the implementation of the study protocol. Duties are determined by protocol-specific requirements. These may include overseeing recruitment and enrollment of study subjects, ensuring compliance with the protocol and continuity of care for the research subject from screening to completion of the study. Safeguard that study data is complete, timely and accurate. This position involves supervision of 1-3 study staff members involved in study recruitment, and assessment of study outcomes.

20%: Operates as a liaison between Principal Investigator, University departments, outside sponsors, clinical partners and collaborators. Provides expertise in technical trouble shooting and safety issues. Serves as a resource for staff, vendors and study sponsors. Works to identify, develop, discuss, and implementing new procedures. Participate in the training of new staff.

5%: Formulates accurate data reporting and works with Principal Investigator to monitor the well-being and safety of the research participant. Responsible for interpretation of, application of, and compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols.

5%: Prepares timely submission of study/regulatory documents (IRB, clinical trials.gov, sponsor reporting). Evaluates adverse event data and advise making submission requests.

Required Qualifications

• BA/BS with at least 5 years of experience, an advanced degree plus at least 3 years of relevant experience, or a combination of education and relevant work experience to equal at least 9…