Clinical Research Study Lead - Program in Advanced Imaging Research (PAIR)

SHIFT:

Day (United States of America)

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A Brief Overview

The Program in Advanced Imaging Research (PAIR) conducts a wide range of studies related to neuroimaging of brain function and structure in young children through adults, with neurodevelopmental and/or genetic disorders, as well as typically developing individuals, across the lifespan.

We are seeking a full-time Clinical Research Study Lead to support the execution of research studies conducted by PAIR investigators and collaborators. The Study Lead will work closely with PAIR’s Research Administrative Manager and will collaborate with investigators, their research staff, clinical psychologists and staff, research regulatory and compliance staff, and Radiology Administration and technical staff to ensure success in the conduct of these research studies.

The Study Lead will also support public-facing interactions, such as recruiting or community support events.

The Study Lead may assist in study documentation, data QA and data analysis. They may also provide support with literature reviews, manuscript preparation, and grant or report submissions.

Successful applicants will be highly self-motivated, detail-focused, independent problem solvers, and fast learners with strong interpersonal skills who enjoy working in bustling clinical research environments. Applicants must have a strong background in the regulatory aspects of research conduct. Experience in RedCap and coding is highly desired. Interest in neuroimaging- MRI, MEG, EEG- and prior experience with autism spectrum disorder or other neurodevelopmental/genetic syndromes are pluses.

While most hours are during standard business hours, some occasional evening hours or weekend hours for recruiting events will be needed for this position. This position is primarily on-site, requiring minimum 90% in-person work.

What you will do

• 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.
• Management Group
• 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.
• Additional responsibilities may include
• 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.
• Education Qualifications
• Bachelor's Degree Required
• Master's Degree in a related field Preferred
• Experience Qualifications
• At least two (2) years of relevant and complex research experience Required
• 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
• Skills and Abilities
• 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
• 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 receive an annual influenza vaccine. Learn more.
• EEO / VEVRAA Federal Contractor | Tobacco Statement