Clinical Research Study Lead - Developmental and Behavioral Pediatrics

Children's Hospital of Philadelphia•Philadelphia, PA

3d•$69,200 - $88,200•Onsite

About The Position

The Developmental Behavioral Research Network (DBPNet) is federally-funded by the Maternal and Child Health Bureau (MCHB). It is a partnership of 16 sites and its mission is to conduct collaborative, interdisciplinary research in developmental and behavioral pediatrics that advances clinical practice, supports research training, and optimizes the health and functional status of children, youth, and young adults with, or at risk for, developmental and behavioral concerns and disorders, including children with autism spectrum disorders and other developmental disabilities. The network has 3 active research nodes focused on ADHD, Autism Spectrum Disorder and Healthcare Innovation and Quality, as well as a Dissemination Committee focused on distributing network research findings to a broad audience including researchers, health professionals, policy makers, educators, families and Title V programs through peer reviewed publications, conference presentations, webinars, the website, and related activities. The Clinical Research Study Lead position is an integral part of the network, responsible for the day-to-day operations and providing administrative support to the research nodes and subcommittees. Responsibilities will include coordinating the review, development, and approval of Network research protocols, coordinating training of staff to implement study protocols and monitor adverse events, and coordinating IRB approval at sites and maintaining documentation that studies are conducted in accordance with good clinical practice and all federal regulations, policies and procedures. The role also involves developing and maintaining data acquisition systems compliant with HIPPA rules to collect intake, treatment, and/or outcome data for participants according to protocol-specific requirements, and monitoring progress of research studies and providing support to participating sites as necessary to ensure the successful completion of the scientific goals of research projects. Additionally, the position will coordinate and attend DBPNet meetings, awards, educational, or other activities as directed by the SC.

Requirements

Demonstrate strong knowledge of good clinical practices, ICH Guidelines, 21 CFR FDA Regulations, and research process.
Have a strong work ethic and be a team player
Be highly reliable and have excellent organizational and time management skills.
Demonstrate a commitment to social justice/diversity and inclusion research
Bachelor's Degree Required
At least two (2) years of relevant and complex research experience Required
Intermediate 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.
Excellent verbal and written communications skills
Excellent interpersonal skills
Excellent time management skills
Strong organizational skills
Strong project management skills
Strong analytical 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 influence others to accomplish tasks outside of the direct span of control

Nice To Haves

Master's Degree in a related field Preferred
At least three (3) years of relevant and complex research experience Preferred
Previous experience with leading clinical research projects Preferred
Previous leadership, management or supervisory experience Preferred

Responsibilities

Coordinate the review, development, and approval of Network research protocols.
Coordinate training of staff to implement study protocols and monitor adverse events.
Coordinate IRB approval at sites and maintain documentation that studies are conducted in accordance with good clinical practice and all federal regulations, policies and procedures.
Develop and maintain data acquisition systems compliant with HIPPA rules to collect intake, treatment, and/or outcome data for participants according to protocol-specific requirements.
Monitor progress of research studies and provide support to participating sites as necessary to ensure the successful completion of the scientific goals of research projects.
Coordinate and attend DBPNet meetings, awards, educational, or other activities as directed by the SC.
Operationalizes study activities and serves as the primary liaison across multiple areas to ensure study success.
Operates autonomously in support of executing the PI’s mission.
Supervises the implementation of and adherence to study protocols. Educates research and clinical staff on established policies, processes, and procedures.
May determine effective strategies for promoting/recruiting research participants and retaining participants in long-term studies.
Interacts directly with investigators.
Coordinates new protocol, consent forms for single or multiple studies.
Coordinates new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
Completes annual reports to Institutional Review Board, CTSA, FDA or other regulatory agencies. Submit Investigational New Drug applications to the FDA as applicable.
Audits operations, including laboratory procedures if applicable, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
May include supporting investigators and working on grants submission.
Oversees financial resources, as needed, creates internal and external budgets for research protocols under the supervision and approval of PI, assures financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
Provide guidance and support for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
May have supervisory/lead responsibilities.
Leads or chairs committees or task forces to address and resolve significant issues.
Engages in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
Analyzes trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
Budget development and management
Effort reporting including complex effort designation, across multiple studies
Contract review and coordination including working with Supply Chain
Report development and communication for sponsors
Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies.