Clinical Research Manager
1 month ago
Location
Ann & Robert H. Lurie Children's Hospital of Chicago
Job Description
Provides leadership, strategic management, and administration for the clinical and translational research program of the Clinical Research Support Service (CRSU): Gastroenterology, Hepatology & Nutrition -Nephrology. Supervises and manages the research staff in the division. Serves as the key operational interface between the funding agencies, research center, research team and principal investigators.
This position will be responsible for the management and oversight of pre-award and post award activities relating to sponsored research studies for the CRSU in conjunction with Office of Sponsored Programs. This includes preparing research budgets, contract negotiations and post award management. 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.
Position Description
Research Administration:
1. Assists principal investigators in preparing applications for funding and managing existing grants and contracts. Implements and interprets research and financial policies and procedures in conjunction with the Office of Sponsored Programs.
2. Works with faculty to identify new federal and foundation funding opportunities, provides insight on funding terms and conditions and submission requirements.
3. Ensures proper post award account creation in financial systems, including Workday, payroll, EPIC and purchasing based on specific grant or contract language.
4. In conjunction with the central office; monitors study funds, reconciling faculty and staff salaries, subcontractor invoices, incoming sponsor payments, cost transfers and other allocable expenses ensuring financial compliance.
5. Provides regular financial status updates including fiscal projections to PIs and director and processes spending plan adjustments at the direction of faculty to meet project objectives.
6. Reviews and coordinates time and effort reporting for faculty and clinical research staff.
7. Works with PIs to regularly monitor information and make changes as appropriate.
8. Works with the SMCRI offices to ensure proper invoices are generated in a timely fashion on all studies, offering training and guidance as appropriate.
9. Assists principal investigators with internal and external budget development for grant applications, including negotiation of budgets with sponsor.
10. Works with the Office of Sponsored Programs to facilitate contract negotiations and execution.
11. Provides oversight of patient charges to fund accounts; verifies accuracy of all charges to fund accounts including salary and miscellaneous expenses.
Management, Coordination, and Communication:
1. Works with other departments/disciplines to coordinate all aspects of research projects, including billing and reimbursement.
2. Serves as a liaison between the faculty and SMCRI, sponsors, CROs, Federal agencies.
3. Participates in division research meetings and sponsor study meetings/teleconferences.
4. Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth.
5. Works with clinical leaders and staff to educate and engage patients and families in clinical research.
6. Establishes strategic plans, policies, and procedures to assist the division and department in fulfilling its research goals and objectives.
7. Promotes the research activities within the division and participates in local and national meetings and works with the faculty to report results via publications and presentations.
Study Initiation and Conduct:
1. Oversees and provides guidance to other research staff in study procedures and processes and monitors team workflow.
2. Has expert knowledge of all functions a clinical research coordinator performs and provides leadership management of education & execution of those responsibilities.
3. Serves as a clinical research leader internal and external and advises other staff regarding complex protocols and projects.
4. Prepares and submits regulatory documents to the government and/or sponsor and provides oversight to other research staff responsible.
5. Prepares/submits budgets, budget justifications and other necessary documents with sponsors.
6. Assists with maintenance of investigator/sponsor files in accordance with FDA and Good clinical Practice (GCP) Guidelines.
Position Qualifications
1. Master's degree in a related field with 3-5 years of experience in clinical research, OR Bachelor's degree with 8-10 years of experience in clinical research financial management or research award administration.
2. Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) required.
3. Expert knowledge of FDA and GCP Guidelines.
4. Excellent organizational skills.
5. Strong analytical ability; ability to understand and interpret financial data; solid quantitative and qualitative skills.
6. Ability to communicate effectively in a leadership role with clinical, business and administrative staff. Ability to work with a team. Strong customer service skills.
7. Exceptional verbal and written communications skills.
Education
Master's Degree: Biomedical Science (Required)
Benefit Statement
For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:
Medical, dental and vision insurance
Employer paid group term life and disability
Employer contribution toward Health Savings Account
Flexible Spending Accounts
Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
403(b) with a 5% employer match
Various voluntary benefits:
- Supplemental Life, AD&D and Disability
- Critical Illness, Accident and Hospital Indemnity coverage
- Tuition assistance
- Student loan servicing and support
- Adoption benefits
- Backup Childcare and Eldercare
- Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
- Discount on services at Lurie Children's facilities
- Discount purchasing program
Lurie Children's and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.
Support email: candidatesupport@luriechildrens.org
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