Sr. Clinical Research Coordinator

Job Details

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.

Job Description

• 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.

Minimum Qualifications

• High School Diploma or equivalent with 6 years of clinical research experience OR
• Bachelors degree with 2 years of clinical research experience OR
• Masters degree with 1 year of clinical research experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

901 Walnut Street Philadelphia Pennsylvania United States of America

Nationally ranked Jefferson which is principally located in the greater Philadelphia region Lehigh Valley and Northeastern Pennsylvania and southern New Jersey is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65000 people strong dedicated to providing the highest-quality compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrows professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic clinical and applied research. Thomas Jefferson University home of Sidney Kimmel Medical College Jefferson College of Nursing and the Kanbar College of Design Engineering and Commerce dates back to 1824 and today comprises 10 colleges and three schools offering 200 undergraduate and graduate programs to more than 8300 students. Jefferson Health nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age race color religion creed sexual orientation gender gender identity marital status pregnancy national origin ancestry citizenship military status veteran status handicap or disability or any other protected group or status.

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues including medical (including prescription) supplemental insurance dental vision life and AD&D insurance short- and long-term disability flexible spending accounts retirement plans tuition assistance as well as voluntary benefits which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues including those who work less than part-time(including per diemcolleagues adjunct faculty and Jeff Temps) have access to medical (including prescription) insurance.

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