Clinical Research Coordinator I

We are seeking a full-time (1.0 FTE) clinical research coordinator for a two-year position beginning July 1, 2021. The clinical research coordinator will assist with all aspects of a research project that aims to reduce disparities in the identification and treatment of sleep disordered breathing (SDB), a prevalent sleep concern that is associated with significant health risks and disproportionately impacts youth of racial/ethnic minority backgrounds. This research project (“Sleep in Primary and Specialty Care Services [Sleep PASS]: Enhancing Primary Care Specialty Care Integration, Collaboration, Patient Outcomes, and Health Equity”) is supported by a Department of Pediatrics Chair’s Initiative and will be conducted in partnership with The Possibilities Project, an effort to optimize and redesign pediatric primary care services. During this research study, the clinical research coordinator and the research team will: develop and meet regularly with an Advisory Board of key clinician, family, and administrative stakeholders; create a clinical pathway that includes social work support, a nurse navigator, and a community/family partner to assist with referrals from primary care to specialty care for SDB assessment and treatment; and conduct an evaluation of this clinical pathway in the CHOP primary care network. The clinical research coordinator responsibilities include: organizing, scheduling, and record-keeping for Advisory Board meetings; literature review for sleep navigation design; IRB protocol development and submission; REDCap database creation and management; and subject recruitment, consent, data collection, and data management for the pilot evaluation.

Additional responsibilities include basic data analysis and preparation of manuscripts, grant submissions, and presentations based on the research project and its findings. Familiarity with REDCap, Qualtrics, or other electronic survey tools, experience with data analysis, and skills in using Excel, SPSS, or other statistical programs is desirable. The clinical research coordinator will join an interdisciplinary team that is led by Drs. Ariel A. Williamson, Alexander G. Fiks, and James Guevara, who are faculty members in CHOP’s Center for Pediatric Clinical Effectiveness.

Job Responsibilities

The coordinator is expected to perform all core responsibilities (as applicable):

• 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

Also may be responsible for any of the following:

• 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 visits

• 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

Preferred Education: BA/BS in a related field

Preferred Experience: 2+ year(s) relevant clinical research experience

Additional Technical Requirements:

Requires effective writing, organizational and communication skills, and ability to multitask; basic knowledge of Good Clinical Practices and the regulations necessary for the protection of human subjects and the conduct of clinical research; demonstration of consistent professional conduct and attention to detail; ability to work effectively on a team.

https://careers.chop.edu/job/Philadelphia-Clinical-Research-Coordinator-I-PA-19146/737735200/?locale=en_US