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Clinical Research Coordinator II - Oncology 65003

Philadelphia, PA, US, 19104

Job Type: 

LOC_COLKET-Colket Translational Research Req ID: 72921

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

The Clinical Research Coordinator II (CRC II) within the Protocol Support Office (PSO) will provide centralized support to clinical investigators and study team members within the Center for Childhood Cancer Research (CCCR).  This position will coordinate and manage regulatory submissions, with a focus on start-up activities. This position will also provide support to oncology researchers (clinical and basic science) by serving as a liaison between investigators and the Office of Collaborative & Corporate Research Contracts and will perform other duties as assigned.

Must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.                                                                                                                                        

Job Responsibilities (Continued)

The CRC II is expected to perform the following responsibilities:

  • Submit new studies to the Pediatric Protocol Review Committee
  • Coordinate and manage regulatory submissions, with a focus on start-up activities, including but not limited to initial Institutional Review Board (IRB) submissions, informed consent development, responses to IRB stipulations, collection of essential documents, coordination of site initiation visits
  • Manage regulatory processes to maintain compliance with institutional SOPs, GCP guidelines, sponsor guidelines and current regulations
  • If appropriate, create electronic regulatory binders for new studies
  • Provide support to oncology researchers (clinical and basic science) by serving as a liaison between investigators and the Office of Collaborative & Corporate Research Contracts; help facilitate timely review and execution of Clinical Trial Agreements, Confidentiality Agreements, Material Transfer Agreements, Data Use Agreements, and other agreement requests as appropriate

Also may be responsible for providing support within the Protocol Support Office for any of the following activities:

  • Assist PSO team members with audit preparation and/or monitoring visits
  • Assist PSO team members with regulatory activities
  • Attend meetings as required/appropriate  
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)
Required Licenses, Certifications, Registrations
Required Education and Experience

Required Education: Bachelor’s Degree in related field


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

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: Five (5) years of relevant 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

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.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

CHOP Careers Contact 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

 

 

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