What are the responsibilities and job description for the Clinical Research Program Manager I - Tsui Informatics Laboratory position at Children's Hospital of Philadelphia?
We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve.
The Tsui Informatics Laboratory at the Children’s Hospital of Philadelphia (CHOP) is seeking a Research Program Manager to support the lab’s mission: to develop and deploy clinical decision support systems aimed to improve health care and address the needs of clinciians. The Research Program Manager will be responsible for overseeing all research studies and projects within the lab, by providing leadership and ensuring implementation of study activities and site management for CHOP and all other participating study sites.
In this role, the Program Manager will work closely with lab director, Dr. Tsui and oversees complex research projects. The Program Manager will also actively create and monitor project timelines and progress, obtain regulatory approvals, design project tracking systems, write governance policies, work with CHOP finance and contracts staff to oversee project budgets and contracts, and communicate effectively with all levels of project stakeholders (including PIs, sponsors, institutional project teams, and internal finance and administrative groups).
The successful candidate will have experience managing projects in a research environment (experience managing data-focused projects preferred), working with large teams of multiple stakeholders, juggling multiple competing priorities, and experience with grant management. Candidates should be able to work with a high level of independence and demonstrate an ability to manage their work proactively. The Program Manager may supervise junior staff as needed.
- Supervision, training, support, and management of staff (direct and/or indirect) to ensure compliance with study protocol, NIH and FDA policies.
- Work collaboratively and effectively with the individual study management teams, various core groups at CHOP’s Research Institute and other participating institutions.
- As part of Management Team, develop, review, and update program policies and procedures as needed.
- Responsible for preparation or overseeing preparation of necessary IRB and project reports.
- Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s).
- Assist with analysis of data and preparation of manuscripts, scientific presentations, and proposals as needed.
- Track regulatory compliance of CHOP and other sites.
- Oversee project budget preparations and billing plans and resolution of billing/budget issues.
- Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.
- Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program.
- Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research.
- Responsible for Regulatory compliance for clinical research program.
- Primary contact for trial for internal and external participants.
Required Experience: Five (5) years of clinical research experience
Preferred Experience:
- Seven (7) years of clinical research experience
- Three (3) years of research administration experience or managing a research group, including budget administration, financial planning, and grants management
- 1-2 years of lead, management or supervisory experience in a clinical research environment
- Experience in an academic institution strongly preferred.
- Medical informatics training or experience
- Excellent customer service and time management skills required. Must be able to work effectively with minimal direct oversight and manage multiple projects with varying deadlines for several individuals. Must be able to juggle multiple demands, work styles and needs.
- Must have strong organizational skills, be able to work accurately, pay strict attention to detail, and be amenable to doing varied work that requires an intellectual and professional approach.
- Successful performance in a high-intensity work environment.
- Excellent problem identification and problem-solving skills.
- Excellent written and interpersonal skills.
- Ability to handle confidential matters and materials.
- Evidence of leadership ability.
- Ability to work with sensitivity to cultural diversity and to assist staff in understanding this diversity.
EEO / VEVRAA Federal Contractor
