Clinical Research Program Manager - Helbig Lab

Children's Hospital of Philadelphia•Philadelphia, PA

53d

About The Position

The Helbig Lab Clinical Research Program Manager will be an essential part of the Helbig lab clinical research team. This person will work directly with Dr. Helbig and other senior faculty of the lab in determining the operational needs and regulatory requirements for ongoing and future studies. This role will support the workload of the Clinical Research Coordinators and Clinical Research Assistants in partnership with the other lab leaders. This role will be responsible for helping to manage IRB and other regulatory body submissions, will support grant applications and ongoing management, and will help with development of projects within the Helbig lab with team support. This person will be a visible member of the team and will have a role across various activities that will help to enrich the research portfolio of the lab. This role functions autonomously in a research setting and responsible for overseeing all research studies for a particular program for multiple PIs. Provides leadership and ensures implementation of study activities and site management for CHOP and all other participating study sites. Will supervise staff. This position requires technical expertise and experience to operationalize, mentor, and guide team members through the entire study lifecycle, from conception through execution and termination. Ability to perform all clinical research coordination activities and additional oversight responsibilities as required.

Requirements

Bachelor's Degree Required
At least five (5) years of relevant & complex research experience Required
At least one (1) year of leadership, management or supervisory experience Required
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

Nice To Haves

Master's Degree in a related field Preferred
At least seven (7) years of relevant & complex research experience Preferred
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

Responsibilities

Supervision, training, support, and management of staff (direct and/or indirect) to ensure compliance with study protocol, NIH and FDA policies.
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.
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.