Sr. Clinical Research Coordinator

Jefferson Health Plans•Philadelphia, PA

2d•Onsite

About The Position

The Senior Clinical Research Coordinator for Neurology works on observational and interventional research, spanning industry sponsored and investigator initiated clinical trials of novel treatments in multiple Neurology divisions. This is a patient facing position with responsibility for subject identification, consenting, data collection and entry, lab sample processing, and maintenance of study documentation according to federal regulations and good clinical practice guidelines.

Requirements

High School Diploma or equivalent with 6 years of clinical research experience
Bachelor's degree with 2 years of clinical research experience
Master's degree with 1 year of clinical research experience

Responsibilities

Oversees day-to-day clinical trial activities in accordance with Good Clinical Practice (GCP) guidelines.
Independently manages or assists with clinical trials from startup through closeout.
Coordinates protocol-related activities, including patient screening, recruitment, enrollment, and informed consent.
Conducts feasibility assessments and study planning activities.
Manages clinical trial data and biological specimens.
Prepares for sponsor monitoring visits and audits.
Prepares and maintains regulatory and Institutional Review Board (IRB) documentation.
Ensures study procedures are conducted in compliance with protocol requirements and applicable regulations.
Trains and supervises research staff on GCP and study-specific procedures.
Assists with onboarding and training of new team members.
Develops and revises workflows, training materials, SOPs, and guidance documents.
Participates in departmental workgroups and process improvement initiatives.
Prepares and submits materials to the IRB and other regulatory bodies in a timely manner.
Maintains subject enrollment and tracking logs.
Tracks study-related expenses and submits documentation for grant and study payments.
Performs quality control reviews to ensure data integrity and regulatory compliance.
Organizes and maintains study records and patient documentation.
Designs and manages electronic data capture databases, when applicable.
Provides clerical and technical support to ensure adherence to research protocols and data quality.