Children's Hospital of Philadelphia
Clinical Research Program Manager - CAR/IDDRC
Philadelphia, PA
Nov 12, 2024
Full-time
Full Job Description

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Day (United States of America)

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Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

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CHOP's Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

About the Job
This role functions autonomously in a research setting and is responsible for managing 1) all administrative activities related to the NICHD-funded Intellectual and Developmental Disabilities Research Center (IDDRC) and 2) provide broad research administrative support for a wide range of grant-related activities for the Center for Autism Research (CAR). The IDDRC and CAR work closely with one another and share common leadership. The Clinical Research Program Manager will be integrated across both entities. The Clinical Research Program Manager will focus on serving as the lead administrator for the IDDRC and secondarily to supplement research administrative support to the Business and Administrative Director of CAR. The CHOP/Penn IDDRC is a collaborative research center that advances research into the causes and treatment of intellectual and developmental disabilities. IDDRC researchers focus on an expansive list of research topics including autism, attention-deficit/hyperactivity disorder, behavioral disorders, Cornelia de Lange Syndrome, epilepsy, Friedreich Ataxia, HIV-associated neurocognitive disorders, and leukodystrophies, to name a few. The work of the Center is adjusted when necessary to accommodate new discoveries. The Clinical Research Program Manager's responsibilities for the IDDRC include programmatic oversight, coordination and preparation of competitive renewal applications and annual progress reports with input from Directors of these programs, and monitoring budgetary spending across all Cores in collaboration with Leadership and the Research Business Administrator (RBA). The Center for Autism Research (CAR), a Research Institute Center of Emphasis, conducts a wide range of studies focused on cognitive, social, neuroimaging, and behavioral characterization of autism and related conditions. CAR maintains a robust grant portfolio that supports more than 100 IRB-approved research projects. Under the supervision of CAR's Business and Administrative Director, the Clinical Research Program Manager will help organize outgoing grant submissions for CAR's primary investigators, support the submission of annual progress reports for prime awards and subcontracts, and support CAR PIs in the accurate accounting of their Other Support documents. Successful applicants will have prior experience with federal and non-federal sponsored research grants and be intimately familiar with NIH grant and reporting guidelines. Prior experience with Workday for grants financial management is a plus. This position will require 1 day on-site each week. Additional on-site time may be required under special circumstances.

What you will do

  • Coordinate administrative activities of the Intellectual and Developmental Disabilities Research Center (IDDRC):
    Oversee financial resources, create internal and external budgets for the Center, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
    Maintain database of all IDDRC users
    Work with Core Directors and users to monitor core utilization and ensure citation of the IDDRC in publications
    In collaboration with Center leadership, develop and distribute users' satisfaction surveys
    Coordinate the activities related to the monthly IDDRC Seminar Series including inviting speakers, coordinating meeting schedules, reserving conference rooms, reserving hotel rooms, ordering from catering, processing reimbursements and honorariums
    Update the external website regularly to maintain a strong web presence
    Coordinate solicitation and review of applications for the New Program Development Award and the Alavi-Dabiri Postdoctoral Fellowship Award
    Schedule regular meetings of the IDDRC Directors, prepare agenda in consultation with the Directors and prepare minutes of the meetings
    Coordinate meetings with the Internal and External Advisory Boards, as needed
    Collaborate with the Community Outreach Manager for meetings with the Community Advisory Board, as needed
    Work with Leadership and Research Business Administration to prepare budgets and monitor expenditures with regular communication of status to Core Directors (approx. $1.4 million annually)
    Assure appropriate regulatory compliance (IRB, IACUC, Biohazards, conflict of interest) for individuals involved in the Center
    Work with Program Directors to prepare annual progress reports and coordinate submission of core progress reports
    Prepare all administrative aspects of the competitive renewals of the Center
    Facilitate integration of IDDRC activities with those of the LEND and other centers that focus on individuals with intellectual or developmental disabilities.
    Collaborate closely with the Program Directors and Training Coordinator of the Training Program in Neurodevelopmental Disabilities (NINDS-funded training grant) as needed for integration of related events and programming
    Participate in the monthly IDDRC network Directors calls (1st Wednesday at noon monthly). Report back to Directors when they are unable to attend
  • Support the Business and Administrative Director at the Center for Autism Research (CAR) with coordination of grant submissions and subcontracts, progress reports, and other grant-related reporting requirements:
    Read and understand grant proposal requirements and develop mutually agreeable plan with PI for proposal completion, including: systematically collecting components (e.g. biosketches, letters of support, facilities descriptions, personnel information); establishing timelines; creating/maintaining collaborative workspaces; and organizing meetings and conference calls.
    Act as a point person throughout the grant proposal preparation process to communicate information to and from Principal Investigator(s), research team members, sponsor (if applicable), sponsored projects officer and administrative director.
    For electronic submissions, upload all documents in correct format and ensure that all required elements are accurate and complete. Work closely with sponsored projects office to see proposal through to submission. For paper submissions, compile all components and oversee sign-off, copying, collating and mailing of all required documents.
    Maintain up-to-date templates of 'non-science' grant sections, including facilities and resource descriptions, protection of human subjects, project management/leadership plan, recruitment & retention, data and resource sharing, data security, organizational capabilities, budget justifications, etc. Work with investigators to write grant-specific biosketches.
    Compile above sections along with sections written by investigative team members (including sub-sites), ensure uniform document formatting, and oversee review and editing of entire document by team.
    Maintains PI Other Support; ensures biosketches are kept current in content and with formatting requirements in consultation with CAR Business and Administrative Director
    Obtains needed documents from subcontractors; prepares subcontract materials for incoming subawards
    Keep abreast of annual reporting requirements for sponsored awards; take a lead role with compiling required data and documents for the submission of all progress reports for prime awards and subcontracts
  • 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.
  • 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 and scientific presentations, as needed.
  • Track regulatory compliance of CHOP and other sites.
  • Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
  • 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.
  • Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle.
  • Supervision, training, support, and management of staff (indirect) to ensure compliance with study protocol, NIH and FDA policies.
  • Additional responsibilities may include
    • Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports.
    • Serve as the primary contact for trial for internal and external participants.


Education

  • Bachelor's Degree Required
  • Master's Degree in a related field Preferred


Experience

  • At least five (5) years of relevant & complex research experience Required
  • At least seven (7) years of relevant & complex research experience Preferred
  • At least one (1) year of leadership, management or supervisory experience Required
  • At least three (3) years of leadership, management or supervisory experience in a clinical research or academic environment Preferred
  • At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management Preferred

Skills and Abilities

  • Excellent verbal and written communications skills
  • Excellent interpersonal skills
  • Excellent customer service skills
  • Excellent time management skills
  • Strong critical thinking / problem-solving skills
  • Strong project management skills
  • Strong organizational skills
  • Strong analytical skills
  • Solid leadership skills
  • Ability to maintain confidentiality and professionalism
  • Ability to work independently with minimal supervision
  • Ability to convey complex or technical information in an easy-to-understand manner
  • Ability to collaborate with stakeholders at all levels
  • Ability to be flexible and adaptable to change


To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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Clinical Research Program Manager - CAR/IDDRC
Children's Hospital of Philadelphia
Philadelphia, PA
Nov 12, 2024
Full-time
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