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Clinical Research Coordinator II

Philadelphia, PA, US, 19104

Job Type: 

WOOD CTR - Wood Building Req ID: 26759

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

Under minimal supervision, coordinates all clinical research activities within the scope of clinical research protocols.

Job Responsibilities

This role is responsible for a portfolio of data abstraction projects including data dictionary development, updating and adapting existing data abstraction documentation, development and maintenance of epidemiologic and operational manuals, and creation of innovative partnerships with clinicians and data management specialists to translate clinical data to patient-centered information. This team member will support innovation in clinical data acquisition for clinical areas of interest including categories of birth defects (e.g. Congenital Diaphragmatic Hernia (CDH), Myelomeningocele (MMC, the most severe form of spina bifida) and process improvement. The team member will work with clinical and research staff in all across the Center for Fetal Diagnosis and Treatment including interests in fetal and pediatric surgery, maternal-fetal medicine, fetal ultrasound, neonatology, pulmonology, cardiology and general pediatrics and psychology.

 

The ideal candidate will collaborate in a professional manner with all members of the healthcare team to promote the goals and objectives of the Division of General Thoracic and Fetal Surgery to realize the vision of the Center for Birth Defects Outcomes. This will require working with a wide variety of individuals across the hospital including clinicians, quality improvement, information systems and research staff. Confers regularly with MD and RN clinical care teams to reconcile conflicting information or locate missing data elements.

  • Self-monitor, report, and self-audit key quality assurance metrics for data validation and data acquisition
  • Support Quality Improvement (QI) and Monitor and Evaluation (M&E) efforts
  • Support manuscript preparation and development
  • Facilitates and/or coordinates project team meetings
  • Provides leadership and guidance to assistants engaged in primary source data acquisition
Job Responsibilities (Continued)

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 experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: One (1) year relevant clinical research coordination experience

Additional Technical Requirements
  • Foundational understanding of statistics, epidemiology and methodology
  • Understanding of MS Excel and statistical software such as Stata and R for data analysis, data cleaning, and reporting

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 or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

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 

Phone: 866-820-9288 

Email:TalentAcquisition@email.chop.edu

 

 

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