CLINICAL RESEARCH ASSOCIATE II

The word “first” is inextricably linked with The Children's Hospital of Philadelphia. Since opening its doors in 1855 as the nation's first hospital devoted exclusively to the care of children, Children's Hospital has been the setting for many dramatic firsts, medical discoveries and breakthroughs that have formed the very foundations of pediatric medicine and benefited children throughout the world.Today, The Children’s Hospital of Philadelphia is a growing network of facilities and resources that provides exceptional healthcare to all children, for every possible need.Find out why we were ranked the #1 pediatric hospital in the nation by both Child Magazine and U.S. News & World Report. If you're looking to join a pediatric institution as your employer of choice, you need to look at the best in the nation.The Children's Hospital of Philadelphia is one of the leading pediatric hospitals and research facilities in the world. Our 150 years of innovation and service to our patients, their families and our community reflect an ongoing commitment to exceptional patient care, training new generations of pediatric healthcare providers and pioneering significant research initiatives.The race to find better care and cures for the illnesses and diseases that strike children is never ending. Children's Hospital is home to one of the nation's largest pediatric research programs, spanning virtually every area of pediatric medicine.Clinical and laboratory research activities are conducted through the hospital's Joseph Stokes Jr. Research Institute, under whose auspices more than 150 investigators and their staffs are pursuing hundreds of active research projects at any given time. Children's Hospital ranks among the top two pediatric hospitals nationwide in National Institutes of Health funding.JOB DESCRIPTION:CLINICAL RESEARCH ASSOCIATE II Conducts site initiation/qualification visits and monitors clinical trials to ensure protocol adherence and compliance with FDA regulations, study-specific operating procedures, ICH guidelines, and Good Clinical Practices (GCPs) including: confirmation of patient eligibility, protocol compliance, patient enrollment tracking, review of informed consent process/forms, maintaining project and visit timelines, conducting study initiation, monitoring and close-out site visits and preparing monitoring reports and site contact documentation, ensuring accurate transcription of data from source documentation to CRFs, and addressing data inconsistencies and clarification with the site staff and data management personnel.
Serves as primary resource for investigational sites and project team. Facilitates discussions and resolution of issues, including monitoring report findings.
Maintains close contact with clinical trial site personnel and assists site personnel in setting up, coordinating, and problem solving during the conduct of a clinical trial. Trains the site personnel regarding protocol requirements and adherence to GCPs and ICH guidelines
Track and obtain outstanding regulatory documents from sites. Ensures that regulatory files at the sites and study sponsor are current and in compliance with GCPs, including IRB approvals, informed consents, etc.
Ensures adequate dissemination of information to relevant study personnel relating to adverse events (serious and non-serious) status and follow-up.
Provides clinical supplies, including case report forms and laboratory supplies, to study sites as requested.Hope Lives Here. Our organization offers total compensation packages befitting a world class institution. Apply online by visiting www.chop.edu/careers, referencing req #06-9107. EOE.If you are a results-oriented individual with a passion for excellence, we invite you to learn more about the many opportunities and benefits The Children's Hospital of Philadelphia offers. Our employees enjoy a competitive compensation package that includes major medical, vision and dental benefits; tuition assistance; employer contribution retirement plan; work/life benefits; extensive training and staff development. And, of course, the opportunity to challenge themselves at a world-class institution.
REQUIREMENTS
Requirements: Minimum of 1-4 years of clinical research associate experience preferred. RN (4 year degree) and/or Bachelors Degree (in science area) required.
Demonstrated computer skills (MS Office).
Strong knowledge of GCPs, ICH guidelines, federal regulations, research process and scientific knowledge of all projects
Excellent oral and written communication skills
Previous clinical trials experience required
30% to 60% domestic travel