Senior Clinical Research Coordinator

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Supervise the daily operations of clinical trials in line with Good Clinical Research Practice (GCP)

• Manage segments of clinical trials from initiation through to completion

• Oversee the processes of screening, recruiting, enrolling, and obtaining consent

• Carry out feasibility assessments and data management tasks

• Handle biological specimens effectively

• Prepare for monitoring visits thoroughly

• Compile regulatory and IRB documentation

• Ensure that study procedures adhere to protocols and relevant regulations

• Aid in the orientation and training of newly hired staff

• Create workflows and training materials

• Update SOPs and guidance documents as needed

• Take part in work groups

• Act as the primary regulatory liaison for designated protocols

• Maintain regulatory binders/files and ensure version control

• Coordinate submissions to ancillary committees, such as Radiation Safety

• Liaise with IRB and sponsors concerning regulatory management

• Collaborate with study teams and sponsors to finalize documents based on PRMC and/or IRB feedback

• Prepare and submit study amendments and applications for continuing review

• Organize regulatory files for audits and monitoring visits

⛳️ Requirements

• High School Diploma/GED

• 5 years of experience with a High School Diploma/GED and SoCRA certification, or 6 years of clinical research experience

• 2 years of experience with a Bachelor’s degree and 2 years of clinical research experience

• 1 year of experience with a Master’s Degree and 1 year of clinical research experience

• Familiarity with Good Clinical Research Practice (GCP)

• Capability to lift and carry weights between 40–50 lbs.

• Frequent to constant standing and walking required

• Ability to perform role-specific physical tasks, including kneeling, bending, squatting, and CPR when necessary

🏝️ Benefits

• Medical insurance, including prescription drug coverage

• Supplemental insurance options

• Dental insurance coverage

• Vision insurance benefits

• Life insurance and Accidental Death & Dismemberment (AD&D) insurance

• Short-term and long-term disability insurance

• Flexible spending accounts available

• Retirement plan options

• Tuition assistance provided

• Optional benefits with access to group insurance rates and discounts

• Tuition discounts at Thomas Jefferson University after one year of full-time employment or two years of part-time employment