Sr Regulatory Program Coord

Temple University

Philadelphia, Pennsylvania

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JOB DETAILS

SALARY

$500–$500 Per Week

SKILLS

Adverse Events, Analysis Skills, Background Investigation, Biotech and Pharmaceutical, CPR Certification, Clinical Research, Communication Skills, Computer Skills, Critical Care, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Health Department, IDE (Integrated Development Environment), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Internal Audit, Interpersonal Skills, Medicine, Microsoft Office, Multitasking, Negotiation Skills, Organizational Skills, Phase I Clinical Trials, Phase IV Clinical Trials, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Coordination, Radiation Safety, Regulations, Regulatory Compliance, Respiratory Medicine, Respiratory Therapy, Team Player, Thoracic Surgery, Time Management, Willing to Travel, Writing Skills

LOCATION

Philadelphia, Pennsylvania

POSTED

30+ days ago

Temple University's Lewis Katz School of Medicine's Pulmonary/Critical Care/Sleep Med Department is searching for a Senior Regulatory Program Coordinator!

Benefits:
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: T26
Learn more about the "T" Salary Structure here.

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.

Job Details:
*This position will be on-site.
*This is a grant funded position.
*This position requires a background check prior to commencement of service.
*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 Summary:
Sr. Regulatory Program Coordinator under the supervision of the Sr. Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department.

REQUIRED AND PREFERRED

Required Education & Experience:
Bachelor's degree and at least five years of experience in research and/or regulatory compliance in a research or clinical setting. An equivalent combination of education and experience may be considered.

Required Skills & Abilities:
*Detail oriented
*Excellent interpersonal and communications skills, including the ability to interact with as diverse constituent population
*Strong analytical and problem-solving skills
*Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously
*Ability to travel, including by air or by car to attend study training meetings as required by study project
*Demonstrated computer skills, and proficiency with MS Office Suite software programs.
*Excellent written and verbal communication skills
*Patient facing experience
*Ability to work independently and in a team environment
*Ability to travel to off-site locations that may not be accessible via public transportation
*Ability to work evenings/weekends hours as needed

Preferred:
*Familiarity with the medical and pharmaceutical industries, and related terminology and practices
*Knowledge of FDA regulations and their practical implementation
*CPR
*IATA training
*Human Subjects training
*Research Certification

ADDITIONAL INFORMATION

Essential Duties:
*Responsible for timely submission of IRB applications, Changes in Protocols, Continuing Review and Adverse Event Reports to the IRB and other committees as applicable including Biosafety Committee, Department of Health submission, or Medical Radiation Safety Committee.
*Responsible for supporting submissions to FDA including IND's, IDE's and Compassionate Use requests.
Materials include but are not limited to applications, consent forms, and protocols.
*Review all forms and applications for validity, readability and consistency between documents.
*Review and negotiate consent forms for IRB standard language, readability and content to ensure simplicity and understanding by any person.
*Conduct thorough review of materials submitted to ensure proper formatting and overall content and appearance.
*Maintain all correspondence from committees (e.g., IRB, SRC, P&T, PRC, DSMB, Audit committees, etc.)
*Participate in sponsor monitoring visits, sponsor audits, internal audits and FDA inspections as assigned.
*Maintain clear and timely communications with the research coordinators, investigators and sponsors regarding progress, issues and requirements.
*Disseminate information on any regulatory changes, trends and precedent setting occurrences pertaining to new requirements.
*Communicate with supervisor progress made on projects,

Sr Regulatory Program Coord

Temple University

Philadelphia, Pennsylvania

About the Company

Temple University

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