GENERAL SUMMARY

The Project Manager - Center for Smart Use Technology to Assess Real - World Outcomes (C-STAR) will primarily be responsible for providing training and operational support to enhance the conduct of research at SRAlab. Principal duties will include creation of new policies and/or standard operating procedures that ensure compliance with industry best practices, and development and deployment of a clinical research training program for SRAlab’s clinical research staff. The Project Manager will additionally provide oversight and support to ensure clinical research performed at SRAlab is conducted in accordance with all established regulations and good clinical practice (GCP).

The Project Manager will interact with diverse research teams working on a wide variety of strategies to help people living with disabilities, and will thus have the opportunity to impact multiple clinical research projects involving therapeutics, medical devices, and physical therapy modalities.

THE PROJECT MANAGER - RESEARCH WILL:

1. Assist in development and implementation of new policies and procedures designed to enhance research operations and compliance with regulatory requirements.
2. Create and implement a training program intended to ensure compliance with internal SRAlab and regulatory policies that pertain to human clinical research.
3. Maintain a regular presence with SRAlab’s research groups to ensure all researchers are aware of and employing industry best practices with respect to human clinical research.
4. Assist clinical investigators with IRB submissions and other regulatory requirements to ensure accuracy and compliance.  
5. Prepare reports for SRAlab, Northwestern University, Clinicaltrials.gov and study sponsors (i.e. federal, foundation and pharmaceutical companies) when necessary.
6. Ensure project documents are complete and current and sent to the appropriate party.
7. Perform all other duties that may be assigned in the best interest of the Shirley Ryan AbilityLab.

KNOWLEDGE, SKILLS & ABILITIES REQUIRED

1. Bachelor’s Degree in a biological or physical science or related field.
2. Skill using a personal computer and word processing, spreadsheet, and database software applications.
3. Knowledge of current Good Clinical Practice (cGCP) and its application in clinical research.
4. Demonstrated experience with project planning in a complex, regulated environment.
5. Communication and interpersonal skills necessary to interact on a daily basis with internal/external customers.
6. Advanced organizational skills necessary to efficiently prioritize and complete a variety of tasks and provide leadership when required.
7. Ability to collaborate effectively in a team setting in order to maximize quality and efficiency of operations.
8. Prior experience as a clinical research coordinator is highly desired but not absolutely required.
9. Ability to understand clinical study protocols and assist study investigators with various tasks when necessary.

SRAlab is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Required Skills Required Experience