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Clinical Research Coordinator I (Leukodystrophy Center)

Philadelphia, PA, US, 19104

Job Type: 

LOC_ABRAMSON-Abramson Building Req ID: 74975

Shift: Days

Employment Status: Regular - Full Time 

Job Summary

The Clinical Research Coordinator I (CRC I) will support the Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN), a federally-funded program that seeks to establish a collaborative research infrastructure across nine participating institutions, enabling collection and analysis of longitudinal natural history data, development of novel clinical outcome assessments, and identification of surrogate biomarkers – ultimately paving the way for transformative therapeutic trials across the leukodystrophies. Regular job responsibilities will include obtaining and documenting informed consent, collecting and entering clinical outcomes data, and coordinating the collection and storage of biological samples. The CRC I will report to the CHOP Leukodystrophy Center’s Program Director, Dr. Adeline Vanderver, MD.

 

The CRC I will work closely with research staff at a number of participating sites - which currently include Baylor College of Medicine (Dallas, TX), Children’s Healthcare of Atlanta (Atlanta, GA), Children’s Hospital of Colorado (Denver, CO), Children’s National Medical Center (Washington, D.C.), Kennedy Krieger Institute (Baltimore, MD), Massachusetts General Hospital (Boston, MA), Stanford Children’s Health (Palo Alto, CA), and the University of Utah (Salt Lake City, UT) – to remotely supervise data abstraction and entry for locally enrolled participants and provide general support to the local investigator and study team. In addition, the CRC I will provide routine support around recruitment, enrollment, scheduling, and sample collection for individuals followed both in-person and remotely at  the CHOP Leukodystrophy Center at any given time.

The GLIA-CTN is a high-volume, fast-paced program, and a successful candidate must be able to demonstrate an ability to multi-task proficiently; prior experience working or volunteering in a clinical research environment is strongly preferred. Outstanding written and oral communication skills are essential, as the position involves regular contact with physicians and clinical staff at participating institutions, and with patients and their families.

 

 

Job Summary (Continued)

This position is intended for individuals interested in a career in in the basic or health sciences, and a successful applicant must have a demonstrable passion for academic research, as well as a desire to make meaningful contributions to a growing body of knowledge.

 

Job Responsibilities:
- Work closely with study teams at the Children’s Hospital of Philadelphia (CHOP) and eight participating institutions to streamline participant recruitment, enrollment, and follow-up for the Myelin Disorders Biorepository Project (MDBP);
- Coordinate study activities with research collaborators at domestic and international MDBP study sites;
- Serve as a primary contact for patients and/or families participating in the MDBP, including consent interviews, coordination of record/sample collection, and scheduling of research study visits;
- Work with laboratory staff to monitor banked biological samples for future research use;
- Possess excellent written and oral communication skills;
- Possess excellent organizational skills, as well as the ability to multi-task and prioritize duties;
- Provide scheduling and administrative support to senior staff as needed;
- Participate in the development and dissemination of scientific manuscripts.

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
Required Education and Experience

Required Education: Associates Degree or active enrollment in a Bachelor’s Degree Program

 

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

Preferred Education, Experience & Cert/Lic

Preferred Education: Bachelor’s Degree in related field

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 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

 

 

CHOP EMPLOYEE? SEARCH FOR JOBS HERE.