Clinical Research Program Manager I - 65014 7/22/2020
The Children's Hospital of Philadelphia
JOB DESCRIPTIONAPPLY LOC_ROBERTS-Roberts Ctr Pediatric Research Req ID: 82145
Employment Status: Regular - Full Time JOB SUMMARY
The Research Program Manager position in the Division of Nephrology will support Dr. Denburg s research program and the grant-funded Pediatric Center of Excellence in Nephrology (PCEN). The individual will be responsible for managing financial and regulatory aspects of Dr. Denburg s research program and will play a major role in the coordination and implementation of PCEN activities and initiatives. This role will support Dr. Denburg s mentoring program and be responsible for tracking mentee progress and providing research guidance and support to the mentees. The Program Manager will assist in the preparation of project deliverables including progress reports, final reports and papers for scientific publications.
Dr. Denburg s research focuses on complications of childhood kidney diseases, including chronic kidney disease (CKD), glomerular disease, and kidney stone disease, with a particular interest in bone health and altered mineral metabolism. The Mission of the CHOP Pediatric Center of Excellence in Nephrology (CHOP PCEN) is to increase efficiency and promote collaborative trials across groups of investigators conducting kidney disease research.
* 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.
* Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports.
* 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 clinical trial budget preparations and billing plans and resolution of billing/budget issues.
* 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.
* Primary contact for trial for internal and external participants.
JOB RESPONSIBILITIES (CONTINUED)
JOB RESPONSIBILITIES (CONTINUED)
REQUIRED LICENSES, CERTIFICATIONS, REGISTRATIONS
REQUIRED EDUCATION AND EXPERIENCE
Required Education: Bachelors in related field
Required Experience: 5-7 years experience in clinical research PREFERRED EDUCATION, EXPERIENCE & CERT/LIC
Preferred Education: Masters in related field
* 3 years of experience in research administration or managing a research group, including budget administration, financial planning, and grants management.
* Experience in an academic institution strongly preferred.
* 1-2 years of supervisory experience in a clinical research environment.
ADDITIONAL TECHNICAL REQUIREMENTS
* Excellent customer service and time management skills required. Must be able to work effectively with minimal direct oversight and manage multiple projects with varying deadlines for several individuals. Must be able to juggle multiple demands, work styles and needs.
* Must have strong organizational skills, be able to work accurately, pay strict attention to detail, and be amenable to doing varied work that requires an intellectual and professional approach.
* Successful performance in a high-intensity work environment.
* Excellent problem identification and problem solving skills.
* Excellent written and interpersonal skills.
* Ability to handle confidential matters and materials.
* Evidence of leadership ability.
* Ability to work with sensitivity to cultural diversity and to assist staff in understanding this diversity.
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children\'s Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children\'s Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.
Children\'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.
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