Clinical Research Specialist-Katz

Temple University's Lewis Katz School of Medicine's Clinical Research Coordinator Department is searching for a Clinical Research Specialist-Katz to join our team!

Become a part of the Temple family and you will have access to the following:
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 and so much more!
Click here to learn more about the benefits of working at Temple University.

Salary Grade: T24
Learn more about the "T" salary structure.

Salary Range: Up to $52,000.00 per year
A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source.

This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.

Job Details:
*This position will be on-site
*This position requires the following background checks: PII/Cash Handling
*This is a grant funded position

Position Summary:
The Clinical Research Specialist 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 career ladder.

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.

This is a grant-funded position and requires a background check. Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. Hybrid work options may be considered depending on study and departmental needs.

Required Education and Experience:
*Bachelor's degree in a life science or other health professions field and a minimum of two years of related experience.
*An equivalent combination of education and experience may be considered.

Responsibilities:
The Clinical Research Specialist supports study coordination activities under the direction of senior staff, following established protocols and procedures. The Specialist performs routine tasks to help ensure the accurate and compliant execution of clinical research projects and refers decisions requiring interpretation of policies or procedures to the Clinical Research Coordinator or other supervisors.

*Perform 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.
*Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.

Other duties and responsibilities:
*May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.
*Performs other duties as assigned.

Required Skills and Abilities:
*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.
*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

Preferred Skills and Abilities:
*Knowledge of IRB and human subject protection
*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.

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.

Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.

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