Clinical Research Study Lead

Reference #: 1012853

SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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.At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.CHOP's Commitment to Diversity, Equity, and InclusionCHOP 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.A Brief Overview

This role functions autonomously in a clinical research setting and responsible for the management of specific research project(s) which may include multiple small to moderate scale clinical trials and studies.Able to perform majority of clinical research coordination activities and additional responsibilities as it relates to operationalizing the vision of the Principal Investigator.Orients & trains staff handling research activities associated with conducting studies. Identifies adequate coverage for study staff needs, potentially across multiple projects, which may vary in administrative complexity.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 coordina ion 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 PreferredExperience 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 PreferredSkills 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 controlTo 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.EEO / VEVRAA Federal Contractor | Tobacco StatementChildren's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.