Clinical Research Manager Neurology

Temple University's Neurology Department is searching for a Clinical Research Manager.

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 Range: $72,000-$90,000
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 position requires the following clearances: Personal Identifiable Information
* Grant-funded position

Position Summary
We are seeking a dynamic and experienced Clinical Research Manager to lead and coordinate clinical research initiatives and outreach within the MDA ALS Center of Hope at Temple University, Lewis Katz School of Medicine. The successful candidate will manage day-to-day operations of the clinical ALS research and community outreach programs, ensure compliance with regulatory requirements, work with research administration on budgets, and foster collaboration among the clinical research and basic research teams.

Required Education and Experience
* Bachelor's degree in a relevant field
* At least five years of related clinical research operations experience.
* An equivalent combination of education and experience may be considered.

Required Skills and Abilities
*Demonstrated computer skills and proficiency with MS Office Suite programs.
*Demonstrated knowledge of GCP and ICH and the application to the conduct of clinical trials.
*Demonstrated expertise with IRB protocols and processes.
*Thorough understanding of cross-functional clinical processes, including clinical supply and data management.
*Strong analytical and problem-solving skills, with the ability to generate successful approaches to addressing issues that arise in the implementation of each study.
*Demonstrated organization and prioritization skills and ability to handle multiple tasks with competing deadlines.
*Exceptional interpersonal and collaborative skills, with the ability to interact effectively with a diverse constituent population in a constructive and engaging manner.
*Excellent written and verbal communication skills.
*Demonstrated supervisory skills.
*Strong attention to detail.
*Ability to travel to offsite locations that may not be accessible via public transportation.
Preferred
*Masters degree in related field

Preferred
*Master's degree in related field

Essential duties
Program Management:
* Oversee the implementation, and evaluation of research projects and programs.
* Develop project timelines, milestones, and deliverables, ensuring goals are met on schedule.
* Monitor program performance, identifying and addressing risks or challenges.
* Interface with research administration throughout the research process from initiation to completion
* Assist with study enrollments as necessary
Grant and Budget Oversight:
* Interface with research administration to properly manage application submissions, and regulatory requirements.
* Review budgets, expenses and projected balances with Research Administration to evaluate efficient and appropriate use of resources.
Team Leadership:
* Mentor clinical research staff as well supervise and mentor the community outreach team
* Serve as lead coordinator on trials where necessary to facilitate and educate other coordinators and maintain continuity
* Facilitate communication and collaboration among the clinical research and outreach programs with external partners.
* Organize and lead team meetings reviewing progress and challenges
Compliance and Reporting:
* Establish and monitor Standard Operating Procedures (SOP's) to ensure Good Clinical Practice (GCP), regulatory guidelines and Best Practices (BP's) are rigorously followed.
* Ensure each study is conducted in accordance with the specific protocols as approved by sponsor, study team and all regulatory agencies.
* Ensure adherence to institutional policies, IRB regulations, and funding agency guidelines.
* Assist in the preparation of progress reports, manuscripts, and presentations as requested by Primary Investigator, Chairman, Administrator and faculty.
* Assure that records of all research activities are maintained
Collaboration and Outreach:
* Build and maintain partnerships with academic, clinical, community, and industry collaborators.
* Represent the program at conferences, seminars, and other professional events.
* Support the dissemination of research findings through publications and presentations.
This position requires a background check

Temple University:Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law.

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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