Senior Clinical Research Coordinator

Job not on LinkedIn

🔥 18 hours ago

🔔 Pennsylvania – Remote

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⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 25%

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Logo of Jefferson

Jefferson

5001 - 10000 employees

🏥 Healthcare

📚 Education

Healthcare • Education

Jefferson is a healthcare organization comprising over 65,000 individuals dedicated to providing high-quality compassionate care and education in the greater Philadelphia region, Lehigh Valley, Northeastern Pennsylvania, and southern New Jersey. It operates 32 hospital campuses and is recognized as a leader in healthcare, focusing on innovative research and the education of future healthcare professionals through its 10 colleges and three schools that offer over 200 programs to more than 8,300 students. Additionally, Jefferson provides health coverage to 360,000 members through Jefferson Health Plans and Health Partners Plans, ensuring access to quality care for over 35 years.

📋 Description

• Oversee day-to-day activities of clinical trials in accordance with Good Clinical Research Practice (GCP) • Run portions of clinical trials from startup to closeout • Coordinate screening, recruiting, enrolling, and consenting • Conduct feasibility planning and data management • Manage biological specimens • Prepare for monitoring visits • Prepare regulatory and IRB documents • Ensure study procedures comply with protocols and applicable regulations • Assist with orientation and training of new staff • Develop workflows and training documents • Revise SOPs and guidance documents • Participate in work groups • Serve as primary regulatory contact for assigned protocols • Maintain regulatory binders/files and version control • Coordinate submissions to ancillary committees, including Radiation Safety • Communicate with IRB and sponsors regarding regulatory management • Collaborate with study teams and sponsors to finalize documents based on PRMC and/or IRB recommendations • Prepare and submit study amendments and continuing review applications • Prepare regulatory files for audits and monitoring visits

🎯 Requirements

• High School Diploma/GED • 5 years with High School Diploma/GED and SoCRA, or 6 years of clinical research experience • 2 years with Bachelor’s degree and 2 years of clinical research experience • 1 year with Master’s Degree and 1 year of clinical research experience • Knowledge of Good Clinical Research Practice (GCP) • Ability to lift and carry 40–50 lbs. • Frequent to continuous standing/walking • Ability to perform role-specific physical activities, including kneeling, bending, squatting, and CPR where required

🏖️ Benefits

• Medical insurance, including prescription coverage • Supplemental insurance • Dental insurance • Vision insurance • Life insurance and AD&D insurance • Short-term and long-term disability insurance • Flexible spending accounts • Retirement plans • Tuition assistance • Voluntary benefits with access to group insurance rates and discounts • Tuition discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service

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