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Regulatory Manager for Clinical Trials - UC San Diego Health

Hiring Unit:

UC San Diego Health

Description:

This position focuses on three critical need areas: (1) provide administrative and regulatory expertise and leadership to support the program development of the clinical arm of the UC San Diego Sanford Stem Cell Clinical Center (2) provide flexible and high-level support of faculty engaged in complex industry sponsored and PI initiated regenerative medicine clinical trials, and (3) provide guidance on regulatory strategies that improve clinical trial design and maximize patient safety while meeting the regulation and UC San Diego policies and procedures.

The Regulatory Manager uses advanced research compliance concepts, logical-thinking, advanced problem-solving and deductive skills to interpret highly complex and broad human research protections, National Institutes of Health (NIH), Food & Drug Administration (FDA), and other federal and state regulations, policies and guidelines. The incumbent regularly works on highly complex human research compliance issues where analysis requires an in-depth evaluation of variable and numerous factors.

The incumbent uses skills as a seasoned, experienced research compliance professional to promote best practices, interacting frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Qualifications:

  • Bachelor's Degree in related area; and/or equivalent experience/training.

  • Five (5+) or more years of experience with submissions to a regulatory group (e.g. HRPP, IRB, FDA) or related experience.

  • Thorough knowledge of FDA regulations, Institutional Biosafety Committee policy and NIH guidelines as they relate to Investigator Initiated Trials (IIT).

  • Demonstrated experience filing Investigational New Drug (IND) Applications to FDA. Extensive knowledge of the Code of Federal Regulations that pertain to new drug development.

  • Experience with regulatory issues in clinical research. Direct experience with FDA, NCI, and ICH regulations and guidelines for clinical studies and medical devices, including GCP’s and GMP’s.

  • Knowledge of compliance issues and proven experience in adherence counseling techniques. Knowledge of Federal and University policies on clinical trials an protection of human subjects.

  • Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. These regulations include but are not limited to 45 Code of Federal Regulations 46, 21 CFR 56, Health Insurance Portability and Accountability Act

  • Strong proficiency in public speaking, and writing. Proven ability to administer, facilitate, appropriately control committee and/or group meetings through leadership, active-listening, and high emotional intelligence.

  • Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology. Advanced knowledge in study design especially designs of trials that involve biologics and cellular therapies preferred.

  • Expertise in clinical trials, investigator-initiated studies, and grant-supported research or related areas. Thorough knowledge of the academic research and medical/scientific terminology and demonstrated ability to comprehend the research process and the various components.

  • Thorough knowledge to properly review research proposals, request necessary additional information from researchers prior to review of adverse events or possible violations of human subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to audit and ensure compliance with the approved protocols.

For more information, click here.

Postdoctoral Researcher - UC San Diego School of Medicine

Hiring Unit:

UC San Diego School of Medicine

Description:

A motivated and independent cancer biology postdoc scientist is sought to work on the identification of RNA and DNA modifications in hematological malignancies. The ideal candidate will have at a minimum, demonstrated molecular and cell biology expertise and experience with flow cytometry, Real-Time PCR, and in vivo mouse models. The successful candidate will design nucleic acid amplification primer and probes for detection of RNA and DNA modifications, clone/optimize lentiviral vectors, examine the developed assay in in vitro and in vivo leukemia models, and validate the function of these modifications using well-characterized clinical samples. The experience of flow cytometry, RT-qPCR, and handling BSL-2 (pathogen) is required.

Qualifications:

The successful applicant must work within an integrated multidisciplinary laboratory and be able to work with project scientists, technicians and students in the team. In addition, the candidate will be expected to report findings to PI and senior scientists.

Appointment Length/Period:

One year

Contact:

Dr. Qingfei Jiang
858-246-1477
q1jiang@ucsd.edu
Interested applicants should email a cover letter, CV, and contact information for three references to Dr. Qingfei Jiang.

For more information, click here.