University of Pennsylvania
Clinical Research Specialist
University of Pennsylvania, Phila, Pennsylvania, United States, 19117
Clinical Research Specialist
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 Director of Clinical Research 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 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. Bachelors degree and 3-5 years of experience or an equivalent combination of education and experience required. Philadelphia, Pennsylvania Perelman School of Medicine $7.25 - $33.00 Hourly Rate 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. 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. Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. 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.
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 Director of Clinical Research 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 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. Bachelors degree and 3-5 years of experience or an equivalent combination of education and experience required. Philadelphia, Pennsylvania Perelman School of Medicine $7.25 - $33.00 Hourly Rate 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. 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. Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. 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.