Clinical Research Study Manager - Philadelphia, United States - Children's Hospital of Philadelphia

Description

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

A Brief Overview

The division of GI, Hepatology and Nutrition is seeking a full time clinical research study manager for the Global ALagille Alliance Study (GALA). The GALA Study is a global initiative to create an international database of clinical, genetic, and laboratory data in children and young adults with Alagille syndrome (ALGS). This management role entails providing clinical research organizational support for the Principal Investigator, Dr. Binita Kamath.

Coordination responsibilities include, but are not limited to, managing the data coordinating center including coordinating data collection and data management activities, verifying the accuracy and validity of data collected. Additional responsibilities include assisting sites with obtaining ethical approval from their respective institutions and establishing data transfer agreements, if applicable.

Excellent communication, organizational, and time-management skills are important. Applicants should have experience working in a clinical setting.

This role functions autonomously in a research setting and responsible for the management of research projects which may include multiple moderate to large scale clinical trials or studies.

Able to perform all aspects of clinical research coordination activities and directly assigned responsibilities as it relates to operationalizing the vision of the Principal Investigator.

Orients and trains staff handling research administration activities associated with conducting complex studies. Identifies adequate coverage for study staff needs, across multiple projects, which 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.
• Supervise the implementation of and adherence to study protocols. Educate research and clinical staff on established policies, processes, and procedures.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Interacts directly with investigators.
• Coordinates new protocol, consent forms for single or multiple studies.
• Oversee and coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
• Complete annual reports to Institutional Review Board, CTSA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Monitor Institutional Review Board submissions, and respond to requests and questions.
• Provide leadership and expertise in identifying and completing research grants.
• 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.
• Provide oversight for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study team.
• Will directly supervise Project Manager I's and Clinical Research Coordinators assigned to the project.
• Management Group
• Lead or chair committees or task forces to address and resolve significant issues.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyze 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.
• Assist with analysis of data and preparation of manuscripts and scientific presentations.
• 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 Preferred

Experience Qualifications

• At least five (5) years of relevant and complex research experience Required
• At least one (1) year of leadership, management or supervisory experience Required
• At least one (1) year of experience leading relevant clinical research projects Required
• At least three (3) years of experience leading relevant clinical research projects Preferred

Skills and Abilities

• Advanced 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
• Excellent organizational skills
• Excellent 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 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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