Job Description
Clinical Research Coordinators facilitate biomedical studies by organizing data collection, enrollment, and compliance for trials that test new treatments in humans, ultimately contributing to medical discoveries that enhance patient care for diverse populations. This work involves managing protocols to ensure ethical and regulatory adherence, supporting investigators in tracking study progress and improving health outcomes through structured research.
Temple University's Lewis Katz School of Medicine hosts a nationally recognized research community focused on patient care across multiple disciplines, offering resources like advanced facilities and collaborative teams. The school advances innovation in healthcare and provides education for future professionals, affiliated with Temple University Health System.
Coordinators independently execute study tasks following protocols, overseeing daily activities in assigned projects, screening and enrolling patients into trials at the Lewis Katz School of Medicine, obtaining informed consent, scheduling visits, and collecting data. They use MS Office Suite, RedCap, OnCore CTMS, Epic Research, and Florence eBinders for data entry and recording. Work involves interacting with investigators, sponsors, and research participants, often requiring evenings or weekends, and includes potential travel to non-public locations, with a challenge of maintaining high detail in dynamic environments.
The full-time day shift role offers a salary range of $50,000 to $55,000, hybrid work options possible, and full medical, dental, vision coverage, paid time off with 11 holidays, tuition remission, and a retirement plan. Certification pathways like CCRP or CCRC qualify for advancement. Requires a Bachelor's degree in a life science or health field, three years relevant experience, proficiency in MS Office, and preferred skills in IRB processes or phlebotomy.
Responsibilities
- 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
- Performs other duties as assigned
- May present project updates at clinical research meetings and/or assist with grant or manuscript preparation
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
- Ability 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