Sr. Clinical Research Coord- Pool

The Temple University's Lewis Katz School of Medicine's Research Administration Department is searching for a Sr. Clinical Research Coordinator-Pool 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!

Salary Grade: T26
Learn more about the "T" salary structure.

Salary Range: Up to $75,000.00 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: Child Abuse Certification and Cash Handling

Position Summary:
The Senior Clinical Research Coordinator-Pool works under the direction of the Director, CRORA, 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 Senior 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.

Required Education and Experience:
*Bachelor's degree in life science or health professions field and four years of directly related clinical research coordinator experience.
*An equivalent combination of education and experience may be considered.

Responsibilities:
The Senior Clinical Research Coordinator independently manages complex study coordination tasks, providing guidance on protocol implementation and regulatory compliance. This role involves making high-level decisions that require a broad interpretation of policies, procedures, and regulatory requirements to optimize study outcomes and maintain the highest standards of quality and compliance.

*Leads and manages the day-to-day operations of all assigned research projects and clinical trials, ensuring study milestones and timelines are met.
*Independently screens, tracks, and enrolls patients in clinical trials and other research studies at the Lewis Katz School of Medicine at Temple University; coordinates and attends sponsor visits and site audits.
*Enrolls human subjects for clinical trials; obtains informed consent, schedules and conducts complex clinical assessments, and ensures accurate and timely data collection and entry.
*Organizes, maintains, and ensures accuracy of all documentation required for clinical trials and other research projects. May maintain up-to-date and audit-ready regulatory binders.
*Serves as a primary resource to the Principal Investigator regarding patient responses to treatment, medication administration, and adverse events; identifies and escalates complex issues.
*May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments.
*Assists the Principal Investigator with strategic planning for IRB submissions, annual reviews, and study close-outs; ensures ongoing regulatory compliance.
*Provides advanced technical and administrative support to ensure adherence to research protocols, enhance study quality, and optimize operational efficiency.
*Ensures compliance with FDA, IRB, Pennsylvania, and other applicable regulations, proactively identifying areas for process improvement and risk mitigation.
*May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.
*May provide informal and/or formal mentorship to other clinical research staff members.
*Performs other duties as assigned

Required Skills and Abilities:
*Proficient in MS Office Suite and clinical research databases; able to manage complex data and generate reports.
*Professional and effective in interactions with diverse stakeholders, including faculty, staff, sponsors, and participants.
*Excellent written and verbal communication skills for reports, regulatory submissions, and correspondence.
*Flexible to work evenings, weekends, or extended hours as needed.
*Strong knowledge of medical terminology, clinical research procedures, and IRB/human subject protections.
*Skilled at identifying and resolving complex problems independently.
*Highly organized, able to manage multiple projects in a dynamic environment.
*Works independently with attention to detail and adherence to protocols and deadlines.
*Available to travel to off-site locations as required.
*Strong time management skills and ability to prioritize competing tasks efficiently.

Preferred Skills and Abilities:
*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.

Additional Miscellaneous Information:
* There may be an opportunity for a hybrid work schedule depending on the department and study specific needs
* This position requires Child Abuse Certifications prior to the commencement of service

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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