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Clin Research Coordinator II - Center for Injury Research and Prevention (CIRP)

Philadelphia, PA, US, 19146

​Location: LOC_ROBERTS-Roberts Ctr Pediatric Research 

Req ID: 203553

Shift: Days

Employment Status: Regular - Full Time 

​About Us
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If you are ready to challenge yourself, be inspired and grow – no matter what your role – you just may be the kind of breakthrough maker who will thrive at CHOP.

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Job Summary

*Hybrid Schedule/Cover Letter Highly Preferred*

Dr. Allison Curry, PhD, MPH, Associate Professor of Pediatrics at the University of Pennsylvania School of Medicine and Director of Epidemiology and Biostatistics at the CHOP Center for Injury Research and Prevention (CIRP), is seeking a talented and strongly self-motivated individual to join her research team as a Clinical Research Coordinator II. Under the direct supervision of Dr. Curry and Project Manager Lauren O’Malley, MPH, the Coordinator II will lead coordination of the day-to-day activities of a large R01 project that includes the conduct of prospective studies to examine driving outcomes among adolescents with neurodevelopmental differences. The Coordinator may also coordinate or assist with various studies included in Dr. Curry’s program of research related to the high burden of and prevention of motor vehicle crashes and other unintentional injuries among children and adolescents.  

Responsibilities will include: leading the coordination of research activities, such as management of regulatory documents and coordination of protocol-related research procedures; leading the coordination of administrative activities, such as preparation of budgets/agreements, IRB protocols and meeting agendas; conducting data collection and management; conducting quantitative data analysis and reporting; assisting in the development of grant proposals and scientific manuscripts.; and directly supervising research assistants and student trainees.

Position contingent upon grant funding.

Job Responsibilities

The Coordinator will be responsible for the following research and administrative activities:
•    Lead the day-to-day organization, coordination, and implementation of an NIH-funded R01 grant and other public health and clinical research studies
•    Write, review, and track science communication products to funding and regulatory authorities (progress reports; IRB submission)
•    Prepare study documents, including protocols, operational manuals consent forms, recruitment materials, and data collection forms
•    Actively oversee the recruitment and enrollment of study participants 
•    Create and manage project-specific databases and surveys in REDCap 
•    Actively oversee data collection and management
•    Providing direct supervision of and coordinating the work of students and research assistants
•    Coordinate the development of scientific manuscripts and presentations
•    Comply with Institutional policies, standard operating procedures (SOPs) and guidelines

The Coordinator may also gain experience with the following: 
•    Identify potential funding/grant opportunities and work with CIRP’s Grant Coordinator to coordinate the preparation and submission of grant proposals
•    Coordinate preparation of budgets, data use agreements, study timelines, and meeting agendas and minutes
•    Conduct literature reviews and prepare literature summaries
•    Track staff outputs and identify opportunities for innovation, outreach, and new activities
•    Act as liaison for research subjects, investigator, research team, IRB, sponsor, and healthcare professionals
•    Data analysis

Job Responsibilities

Core responsibilities

  • Adhere to an IRB approved protocol
  • Participate in the informed consent process of study subjects
  • Support the safety of clinical research patients/research participants
  • Coordinate protocol related research procedures, study visits, and follow-up care
  • Screen, recruit and enroll patients/research participants
  • Maintain study source documents
  • Report adverse events
  • Understand good clinical practice (GCP) and regulatory compliance
  • Educate subjects and family on protocol, study intervention, etc.
  • Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
  • Must comply with federal, state, and sponsor policies

 

Related responsibilities

  • Manage essential regulatory documents
  • Register study on ClinicalTrial.gov
  • Complete case report forms (paper & electronic data capture) and address queries
  • Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
  • Facilitate pre-study, site qualification, study initiation, and monitoring visit
  • Facilitate study close out activities
  • Coordinate research/project team meetings
  • Collect, process and ship laboratory specimens
  • Schedule subject visits and procedures
  • Retain records/archive documents after study close out

 

Also may be responsible for any of the following:

  • Manage study finances including sponsor invoicing & resolving study subject billing issues
  • Develop advertisement materials
  • Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Document investigational product (drug/device) accountability
  • Self-monitor and self-audit responsibilities
  • Develop informed consent document
  • Maintain Clinical Trial.gov 
  • Develop Case Report Forms
  • Assignments to include more complex studies

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education: Bachelor’s Degree

 

Required Experience: Three (3) years of clinical research coordination experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: Five (5) years of clinical research coordination experience

Additional Technical Requirements

  • Excellent verbal and written communications skills
  • Excellent time management skills
  • Ability to collaborate with stakeholders at all levels

To carry out its mission, it is of critical importance for the Children’s Hospital of Philadelphia (CHOP) to keep our patients, families and workforce safe and healthy and to support the health of our global community. In keeping with this, CHOP has mandated all workforce members on site at any CHOP location for any portion of their time be vaccinated for COVID-19 as a condition of employment.  This mandate also applies to workforce members performing work for CHOP at non-CHOP locations. Additionally, all workforce members based in or regularly scheduled to work at any New Jersey location are mandated to be both vaccinated and boosted for COVID-19, with booster timing consistent with applicable guidelines. The CHOP COVID-19 vaccine mandate is in alignment with applicable local, state and federal mandates. CHOP also requires all workforce members who work in patient care buildings or who provide patient care to receive an annual influenza vaccine. Employees may request exemption consideration for CHOP vaccine requirements for valid religious and medical reasons.  Please note start dates may be delayed until candidates are fully immunized or valid exemption requests are reviewed. In addition, candidates other than those in positions with regularly scheduled hours in New Jersey, must attest to not using tobacco products.
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