Job Description
These professionals manage clinical trial operations by coordinating enrollments and data handling, contributing to studies that test new respiratory treatments, potentially advancing care for patients with asthma, lung cancer, and severe conditions through rigorous data and compliance management. Coordinators support recruitment efforts in pulmonary clinics, using technology for chart reviews and screenings.
Temple University's Lewis Katz School of Medicine leads in pulmonary research with active trials on conditions like COPD and pulmonary fibrosis, providing resources for high-enrollment studies and collaborating on NIH, industry, and investigator initiatives. The program emphasizes innovative patient care through multidisciplinary teams and advanced facilities.
Coordinators oversee project activities, screen and enroll patients, obtain consent, schedule visits, perform assessments, and enter data. They organize binders, handle IRB submissions, provide clerical support, and assist with grant preparations. Tools include RedCap, OnCore CTMS, Epic Research, Florence eBinders, and MS Office. They recruit via chart reviews, speak to potential subjects, arrange visits, and track referrals, interacting with marketing teams and IT for outreach tools. Evenings/weekends may be required, with potential travel.
This full-time day shift position offers salary of $50,000 to $55,000, hybrid options possible, full medical, dental, vision coverage, paid time off with 11 holidays, tuition remission, and a retirement plan. Certification bonuses apply. Requires Bachelor's in life sciences, three years experience, computer proficiency, and preferred knowledge in IRB, biologics processing, phlebotomy, data entry, and healthcare research.
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
- 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
- Prior experience with IRB submissions (preferred)
- Prior experience processing and shipping biological samples (preferred)
- Prior phlebotomy certification or willing to learn (preferred)
- Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders (preferred)
- Prior Electronic Data Capture (eDC) data entry skills (preferred)
- Prior research experience in a healthcare setting (preferred)
- Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies (preferred)