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Sr Research Associate-Urology

Temple University

Philadelphia (Philadelphia County)

On-site

USD 50,000 - 80,000

Full time

14 days ago

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Job summary

An established industry player is seeking a Senior Research Associate to lead clinical trials in the Urology Department. This exciting role involves planning, implementing, and executing research activities while collaborating with clinical investigators. You will manage participant enrollment, oversee study protocols, and ensure compliance with ethical guidelines, making a significant impact in advancing medical knowledge. Join a dynamic team dedicated to improving patient outcomes and contributing to groundbreaking research in urology. This position offers a chance to work with experts in the field and develop your skills in a supportive environment.

Benefits

403 (B) Retirement
Generous time off
Parental Leave
Tuition Remission
Great Benefit package
Dynamic Workforce

Qualifications

  • 4 years of clinical research coordinator experience required.
  • Strong written and verbal communication skills needed.

Responsibilities

  • Coordinate study enrollment and oversee study protocols.
  • Maintain accurate records and ensure compliance with regulations.

Skills

Clinical Research Coordination
Data Entry (eDC)
IRB Submissions
Communication Skills
Office Software Proficiency (MS Office)

Education

Bachelor's Degree in Life Science

Tools

Redcap
Epic
Excel

Job description

Description

Grade: T26


The link below will give you information about the University's "T"


salary structure.


Learn more about the "T" salary structure.



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.



Summary:


The Senior Research Associate, in collaboration with the Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Trials in the Urology Department. They will work independently to drive day to day research activities.


Primary responsibilities include the coordination of study enrollment, oversight of study protocols, and submission of research activities per IRB regulations. Incumbent will establish and maintain databases of subjects, process informed consent paperwork, and ensure study payment is processed and received in a timely fashion, register subjects and study visits in OnCore; perform Epic research billing review; maintain an up to date regulatory binder; schedule and attend sponsor visits. Additional responsibilities include working independently to drive day to day research activities, supporting multiple active protocols simultaneously, and working with multiple investigators while adhering with HHS, FDA, IRB, Pennsylvania, and related regulations.



The Department of Urology at the Lewis Katz School of Medicine has national and international experts dealing with both benign and oncologic urology. We are fortunate to have fellowship trained urologists in truly all aspects of urology including; pediatrics, reconstruction, oncology, female pelvic medicine and reconstructive surgery, endourology, andrology/male infertility, gender affirming surgery and neurourology.



Essential Functions:


* Study Preliminary Evaluation: Evaluate new studies for feasibility and coordinate start up with sponsors and internal departments and sites.


* Participant Enrollment: Search available databases for potential participants, evaluate eligibility, complete informed consent documentation and recruit for participation


* Oversight of Study: Schedule and conduct study visits and participate in monitoring visits. Oversee study protocols are met at all levels of participant enrollment, visits and documentation. Ensure study payments are processed and received in a timely fashion.


* Documentation: Maintain accurate records by establishing and maintaining patient entries in databases of subjects in eDC. Submit all research activities per IRB regulations.


* Literature Review: Conduct literature reviews to support ongoing research efforts, summarizing relevant findings and methodologies. Assist with grant or manuscript preparation.


* Team Collaboration: Work collaboratively with researchers, graduate students, and external partners to facilitate communication and input in research design and implementation. Provide on boarding training and exit debriefing to medical students and trainees when they join our and leave our Research team. Attend quarterly research meetings with our faculty, trainees, and medical students.


* Ethics and Compliance: Ensure compliance with ethical guidelines and institutional policies concerning human subject research.


* Support Multiple Studies-Support multiple studies to support multiple active protocols simultaneously. Work with multiple investigators while adhering with FDA, IRB, Pennsylvania and related regulations.



Required Education & 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.



Benefits of working at Temple University include:


403 (B) Retirement


Great Benefit package


Generous time off


Parental Leave


Tuition Remission


Dynamic Workforce



Click here to learn more about the benefits of working at Temple University.



Required Skills & Abilities:


*Will be required to learn about urologic and various medical diseases and management of diseases to familiarize themselves on study goals and fulfill database management needs.


*Available to work evenings/weekends around time of deadlines or urgent submission needs.


*Prior experience with IRB submissions both local, central and multi-institutional


*Strong eDC data entry skills.


*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants..


*Ability to operate all standard office equipment/software including MS office.


*Ability to work independently or as a team with attention to detail and adherence to project deadlines.



Preferred:


*Prior experience working with surgical subspecialties and possibly urologists


*Prior experience working with Redcap databases


*Understanding of statistics and/or prior experience with statistical analysis software would be a big plus


*Excel spreadsheet experience



This position requires a background check.


This is a grant funded position.



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.


To obtain additional information about Temple University please visit our website at www.temple.edu.


Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here.


You may request a copy of the report by calling Temple University's Campus Safety Services at 215-204-7900.


Primary Location:Pennsylvania-Philadelphia-Health Sciences Campus (HSC)
Job:Staff
Schedule:Full-time
Shift:Day Job
Employee Status:Regular
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