Clinical Research Coordinator
Job Details
The Clinical Research Coordinator for Neurosurgery 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
- Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).
- Manages portions of clinical trials from startup to closeout, including:
- Protocol coordination (screening, recruiting, enrolling, consenting)
- Feasibility planning and data management
- Biological specimen management
- Preparation for monitoring visits
- Regulatory and/or IRB document preparation
- Ensures all study procedures are conducted according to the protocol and applicable regulations.
- Assists in orienting and training new staff members.
- Contributes to the development and revision of workflows, training materials, and SOPs/guidance documents.
- Participates in departmental and project-related work groups.
- Trains and supervises research staff on proper clinical trial procedures per GCP.
- Prepares and submits all IRB and regulatory materials in compliance with timelines and requirements.
- Maintains accurate subject logs and tracks study expenses; coordinates with the Grant Administrator for visit payments.
- Performs regular quality control checks to ensure data accuracy and compliance.
- Organizes and maintains complete documentation of all patient data.
- Designs and manages electronic data capture databases, as applicable.
- Provides clerical and technical support to ensure adherence to research protocols and data quality.
Education and Requirements:
High School Diploma or equivalent and 6 years of clinical research experience, or
Bachelor's degree and 2 years of clinical research experience, or
Master's degree and 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
909 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 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's 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 8,300 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 diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
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