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Clin Research Coordinator II - Center for Bone Health

Philadelphia, PA, US, 19146

Location: LOC_ROBERTS-Roberts Ctr Pediatric Research 

Req ID: 134100

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

The successful candidate will join the research team of Dr. David Weber in the Center for Bone Health (Division of Endocrinology and Diabetes) at The Children’s Hospital of Philadelphia. Dr. Weber’s research focuses on improving the clinical care of children with impaired bone health from genetic conditions or secondary to severe childhood disease. He is building a research team that will work on multiple bone health related projects including investigator initiated prospective observational studies in children with primary (such as osteogenesis imperfecta) and secondary osteoporosis (such as Duchenne muscular dystrophy or diabetes), industry sponsored observational and clinical trials in children with rare bone diseases, quality improvement projects within the Center for Bone Health, and epidemiologic studies utilizing local and multi-center clinical records databases.

 

The ideal candidate will have a Master’s Degree in Public Health, Epidemiology, Biostatistics or a related field. Prior research experience and in patient-oriented research is required. The applicant is expected to work comfortably as part of a research team and will work on multiple research studies at any given time. The successful applicant should have strong communication, writing, organizational, and analytical skills. Job responsibilities will include participation in grant writing, protocol development, study implementation, subject recruitment, conduct of study visits, study management, budget management, data analysis, and potentially contribution to manuscript writing.

 

Dr. Weber works closely with other physicians and researchers within the Center for Bone Health, Metabolism, Nutrition, and Physical Development Research Affinity Group, and The Center for Pediatric Clinical Effectiveness. The candidate will be integrated within these research networks which will allow for robust senior, peer, and near-peer mentoring  and provide opportunities for career advancement.

 

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

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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