Clinical Research Coordinator
About The Position
The Clinical Research Coordinator works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured step increase program. We also recognize and reward professional development. Coordinators who successfully earn industry-recognized certifications, such as the Certified Clinical Research Professional (CCRP®) through SOCRA or the Certified Clinical Research Coordinator (CCRC®) through ACRP, may qualify for advancement sooner. At Temple University’s Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine.
Requirements
- Bachelor’s degree in a life science or other health professions field
- A minimum of three years of related experience
- An equivalent combination of education and experience may be considered.
- Demonstrated computer skills, and proficiency with MS Office Suite software programs.
- Aptitude in professionalism
- Excellent written and oral communications skills
- Ability to work evenings/weekends hours as needed.
- Knowledge of medical terminology
- Able to resolve problems/issues
- Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants
- Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously.
- Knowledge of IRB and human subject protection
- Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.
- Ability to travel to off-site locations that may not be accessible via public transportation.
- Strong time management skills
Nice To Haves
- Prior experience with IRB submissions.
- Prior experience processing and shipping biological samples.
- Prior phlebotomy certification or willing to learn.
- Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders.
- Prior Electronic Data Capture (eDC) data entry skills.
- Prior research experience in a healthcare setting.
- Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies.
Responsibilities
- Performs study coordination tasks independently, following established protocols and procedures. The coordinator makes decisions that require interpretation of policies, procedures, or instructions to ensure accurate and compliant execution of clinical research projects.
- Oversees the day-to-day activities of all assigned research projects and clinical trials.
- Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits.
- Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data.
- Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data.
- Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders.
- Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects.
- May submit IRB paperwork to ensure compliance with IRB regulations.
- Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews.
- Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received.
- May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments.
- Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.
- May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.
- Performs other duties as assigned
Benefits
- Full medical, dental, vision coverage
- Paid time off
- 11 Paid Holidays
- Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE
- A generous retirement plan
- employee referral program-TERP!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
