Clinical Project Associate Jobs in Geneva, IL (NOW HIRING)

The Manager, Clinical Research role provides leadership, strategic management, and administration for clinical and translational research. Supervises and manages the research staff in the divisional unit. Serves as the key operational interface between the funding agencies, Stanley Manne Children's Research Institute (SMCRI), research team, and principal investigators. Works with a multidisciplinary team of physicians and staff to maintain an environment that encourages customer service and promotes employee satisfaction. Models and supports the principles of good clinical practice with the research team.

Essential Job Functions:

• Serves as a clinical research leader to research and clinical staff both internal & externally regarding study procedures and processes, monitoring team workflow, and advises on implementation of complex protocols and projects.
• Has expert knowledge of all functions a research coordinator performs and provides leadership management of education & execution of those responsibilities.
• Establishes strategic plans, policies, and procedures to assist the research program in fulfilling its research goals and objectives.
• Disseminates critical clinical and operational updates and information from the hospital and research institute to research teams in real-time.
• Assists principal investigators to identify new federal, foundation, and industry funding opportunities, prepare applications for funding, and manages existing grants and contracts. Implements and interprets research and financial policies and procedures in conjunction with the Research Business Operations (RBO) offices and Office of Clinical and Community Trials (OCCT).
• Provides oversight and accuracy of all charges to applicable grant/gift accounts including salary and miscellaneous expenses.
• Reviews and coordinates time and effort reporting for faculty and clinical research staff. Responsible for pre-award and post-award activities with principal investigators relating to sponsored research grant proposals and projects in conjunction with the Research Business Operations (RBO) offices.
• Works with the Research Business Operations (RBO) offices and Office of Clinical and Community Trials (OCCT) to facilitate contract negotiations and execution, to ensure proper accrual tracking, and to provide additional information as needed for timely financial reconciliation, management, and reporting.
• In conjunction with the SMCRI central offices; monitors study funds, reconciling faculty and staff salaries, subcontractor invoices, incoming sponsor payments, cost transfers and other allocable expenses ensuring financial compliance.
• Provides oversight and accuracy of all charges to applicable grant/gift accounts including salary and miscellaneous expenses.
• Reviews and coordinates time and effort reporting for faculty and clinical research staff.
• Works with other departments/disciplines/ancillary support services to coordinate all aspects of research projects. Ensure up-to-date document management and participant tracking in applicable Lurie systems (study intake, eRegulatory, eRA, CTMS, Epic, etc).
• Prepares and submits regulatory documents to the government and/or sponsor and provides oversight to other research staff responsible.
• Prepares for and leads audits and participates in discussion with regulatory authorities.
• Partners with the Office of Research Integrity and Compliance (ORIC) to ensure compliant research execution. Leads or participates in division research meetings and sponsor study meetings/teleconferences.
• Promotes the research program by participating in local and national meetings and works with faculty to report results via publications and presentations.
• Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth. The authority to hire, separate, promote, demote, write, and administer performance evaluations.

Knowledge, Skills and Abilities:

• Bachelor's degree and five or more years research experience required. Master's degree and/or relevant research certification preferred.
• Expert knowledge of FDA and GCP Guidelines.
• Excellent organizational skills with ability to manage simultaneous project plans and personnel.
• Strong analytical ability to understand and interpret financial data, solid quantitative and qualitative skills.
• Ability to communicate effectively in a leadership role with clinical, business and administrative staff. Ability to work with a team. Strong customer service skills.
• Exceptional verbal and written communications skills.