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Seeking Breakthrough Makers

Children’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 Inclusion

CHOP 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 job coordinates clinical research activities at The Children's Hospital of Philadelphia (CHOP) including CHOP's Care Network.

Leads a staff of clinical research coordinators and provides training, support, guidance, and leadership for the conduct of clinical research projects. May be expected to perform or provide guidance for direct patient care (clinical assessments) in relationship to study protocol demands. Provides orientation and ongoing education and training to staff and participates in quality improvement initiatives for CHOP. Participates in the evaluation of new protocols in order to determine needs for study staffing and implementation, development of protocols and budgets, submission of IRB applications, and development and maintenance of CRSO standard operating procedures.

Applies knowledge of regulations, guidance's, and Good Clinical Practices (GCP), including the protection of human research subjects with particular emphasis on pediatrics, reporting requirement for adverse events, elements of informed consent, and other local laws, policies, and procedures that govern the performance and conduct of clinical research activities.

What you will do

• Actively involved in the recruitment, hiring, orientation, ongoing training, and retention of staff. Supervise and guide a team of clinical research coordinators through established problem-solving process for setting up and maintaining clinical research projects. Monitor outcomes and suggest departmental changes to make training and management process more effective and/or efficient. Identify areas for improvement and make recommendations for re-allotment of resources, as needed.
• Performs ongoing performance management activities including the Im PACT evaluation. Ensures staff is appropriately trained to perform the tasks delegated to them, and ensures staff have appropriate required skills, e.g., CPR, to perform job responsibilities.
• Assist leadership in evaluating new study protocols and current staff workloads to assist in determining the distribution of new projects/workloads.
• Develop and maintain tools, processes, programs, and standard operating procedures (SOPs) designed to support the conduct of clinical research.
• Quality Assurance: Work with Principal Investigators to ensure Regulatory and Institutional Compliance for all study protocols supported by direct reports.
• Assure appropriate regulatory compliance, IRB approval and renewal, and appropriate training of all research personnel
• Ensure coordinators are adhering to best practices including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence
• Conduct quality assurance reviews/audits on supported projects to ensure protocol compliance, accuracy of data collection, adherence to regulations and applicable good clinical practice guidelines. Audit reports will be created and submitted to leadership
• PI satisfaction: Ensure team coordinators meet with and maintain weekly communication with all study PIs regarding study progress, status, enrollment and other pertinent issues, as necessary. Team Manager should attend these meetings as needed.
• Clinical Research Budgets and Billing Compliance: In collaboration with the Clinical Research Support Office (CRSO) and Clinical Trials Financial Management (CTFM), assist in the development of staffing budgets that appropriately cover costs of study implementation. Also monitors to ensure billing compliance through adherence to CHOP research billing processes.
• Trial Enrollment: Work with coordinators and PIs to strategize recruitment methods for studies to ensure accrual objectives are met.
• Quality Improvement Initiatives: Work with management team to identify, develop, and implement quality improvement initiatives.
• As a member of the management team, provide administrative leadership and oversight to coordinators, including guidance on GCP, protocol conduct, etc. and provide pertinent updates to leadership in a timely manner.
• Demonstrate an ability to lead and motivate team members with vision, integrity, and flexibility.
• Work with leadership to develop, organize, maintain, and manage the infrastructure and resources necessary for supporting quality clinical research.
• Participate in Research Institute-sponsored education and training activities as requested.
• Perform other duties as assigned.

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in Public Health or related field Preferred

Experience Qualifications

• At least five (5) years of clinical research and conducting/coordinating research study experience Required
• At least two (2) years of nursing experience Required
• At least one (1) year of leadership, management or supervisory experience Required
• At least seven (7) years of clinical research and conducting/coordinating research study experience Preferred
• At least three (3) years of nursing experience in a medical, surgical, oncologic or cardiologic area Preferred
• At least three (3) years of leadership, management or supervisory experience Preferred
• Previous experience with IND or IDE clinical trials Preferred
• Previous experience with clinical assessments Preferred
• Previous experience in pediatrics Preferred

Skills and Abilities

• Advanced knowledge of Good Clinical Practice [GCP] guidelines including protection of human subjects, definitions and reporting requirements for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials (Required proficiency)
• Advanced knowledge of hospital systems (Epic, Chart Maxx, etc) (Required proficiency)
• Advanced proficiency with office software (Microsoft Office) including word processing, spreadsheet, and presentation software (Word, Excel, Power Point) (Required proficiency)
• Excellent verbal and written communications skills (Required proficiency)
• Excellent interpersonal skills (Required proficiency)
• Strong time management skills (Required proficiency)
• Strong organizational skills (Required proficiency)
• Strong critical thinking / problem-solving skills (Required proficiency)
• Strong conflict resolution skills (Required proficiency)
• Strong leadership skills (Required proficiency)
• Ability to influence others to accomplish tasks outside of the direct span of control (Required proficiency)
• Ability to maintain confidentiality and professionalism (Required proficiency)
• Ability to collaborate with stakeholders at all levels (Required proficiency)
• Ability to be flexible and adaptable to change (Required proficiency)
• Willingness and ability to travel required. Periodic overnight travel may be required (Required proficiency)

Licenses and Certifications

• Clinical Research Professional (CRP) - Society of Clinical Research Associates (SOCRA) - within 12 months - Required or
• ACRP Certified Professional - Association of Clinical Research Professionals (ACRP) - within 12 months - Required or
• Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP) - within 12 months - Required
• Registered Nurse (Pennsylvania) - Pennsylvania State Licensing Board - - Preferred
• Registered Nurse (New Jersey) - New Jersey State Licensing Board - - Preferred

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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