Clinical Research Specialist

The company name is "The Perelman School of Medicine".; United States; Remote; USD 60,000 - 80,000; Part time

Job summary

An established industry player is seeking a part-time Regulatory Affairs Start-Up Specialist to support the initiation of clinical trials. This role involves managing regulatory documentation, collaborating with research teams, and ensuring compliance with FDA and institutional requirements. The ideal candidate will have a background in regulatory affairs and clinical trials, with the ability to work independently. Join a prestigious institution that values innovation and excellence in research, and contribute to impactful health solutions while enjoying a supportive work environment in the heart of Philadelphia.

Benefits

Comprehensive medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement plans

Qualifications

• 3-5 years of experience in regulatory affairs or clinical trials.
• Bachelor's degree required; equivalent education and experience accepted.

Responsibilities

• Facilitate regulatory aspects of clinical trials with minimal supervision.
• Prepare and process regulatory documentation for IRB, FDA, and other committees.

Skills

Regulatory Affairs

Clinical Trials Management

Documentation Management

Communication Skills

Education

Bachelor's Degree

Job description

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer, Penn has been ranked nationally on many occasions, with the most recent award from Forbes naming Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

Posted Job Title

Clinical Research Specialist

Job Profile Title

Temporary Employee - Non-Exempt

Job Description Summary

Temporary Employee - Non-Exempt

Job Description

Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision, the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Reporting to the Director of Clinical Research, the specialist will prepare and process, with minimal supervision, all initial oversight submissions for regulatory documentation through the IRB, FDA, and all applicable institutional regulatory review committees. In collaboration with clinical research teams and investigators, he/she will prepare and process all required regulatory documentation for NIH, pharmaceutical companies, contract research organizations (CROs), and the FDA, as well as organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as communicate the transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Start-Up Specialist is expected to oversee, with minimal supervision, the development of investigator-initiated research protocols, grant applications, the development and submission of FDA IND applications, and the development of study-specific forms and source document tools, as well as to provide direct regulatory/compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site trials.

Minimum Qualifications: Bachelors degree and 3-5 years of experience or an equivalent combination of education and experience required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$7.25 - $33.00 Hourly Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and the pay range assigned to the job profile.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state, or local law.

Special Requirements
A background check may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health and Life: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

Please note that benefit eligibility is determined/based on ACA guidelines.