Clinical Affairs Associate/Senior Associate

Company: Nephrosant
Location: San Mateo
Posted on: March 20, 2023

Job Description:

Clinical Affairs Associate/Senior Associate Product Management - Product Management / NephroSant is a fast-paced diagnostic startup focused on applying the founding team's years of clinical research expertise to improve global kidney health. Our mission is to translate the deep scientific and pathological insights into best-in-class noninvasive tests to address the hidden epidemic of chronic kidney disease which affects more than 10% of the world's adult population. We are looking for a highly motivated Clinical Affairs Associate to support our clinical research program. This is a regular full-time position. The Clinical Affairs Associate, together with the Senior Director of Clinical Affairs, is directly responsible for coordinating the clinical operations function in alignment with NephroSant's goals and needs.With a focus on project efficiency and high-quality deliverables, this person will be responsible for operational aspects of one or more clinical research programs and play a significant role in overseeing vendor clinical trials staff and impacting the success of NephroSant's overall clinical research program. - A mix of biotech, clinical, academia and/or CRO experience is highly desirable. Responsibilities

• Participates in the implementation and direction of clinical studies as part of the Clinical Affairs team. -
• Collaborate with vendors and consultants to ensure successful clinical trial implementation and execution. -
• Participates in the design, preparation, writing and review of clinical documents including protocols, investigator brochures, case report forms, informed consents, and other specialized forms for clinical trials. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial. -
• Evaluates data from clinical sites to ensure completeness, accuracy, quality, and integrity in combination with consultants and vendors. -
• Collaborate with study team and/or consultants to ensure completeness & accuracyof the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc. -
• Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with applicable guidelines -
• Liaise with clinical site staff and Investigators, as appropriate, to ensure optimal Sponsor-site relationships. -
• Supports the development of Clinical Affairs' operation procedures -
• Develop study supply assumptions and ensure sites have adequate study supplies for clinical trials. -
• Management of site timelines, pre- study visits, site selection, site initiation, site management and closeout activities. -Qualifications
  • BS, RN, or MS in a relevant scientific discipline, or equivalent. -
  • Minimum 4 years (6+ years preferred) of progressive experience in human subjects clinical research with involvement in operational aspects of all stages of clinical research, including monitoring and execution. -
  • Knowledgeable and strong contributor to writing key clinical documents (protocols, reports, ICFs, etc.); Protocol, ICF, and related writing experience required. -
  • Thorough understanding of FDA regulations and Good Clinical Practices (GCPs) -
  • Outstanding oral and written communication skills -
  • Strong analytical and organization skills as well as demonstrated ability to solve problems with innovative solutions -
  • Ability to multi-task effectively, prioritize assignments from multiple sources and to adapt to changing program needs in real-time. -
  • Strong team player that has a customer service approach and is solution oriented. - What we offer: - - Competitive Compensation Package, Including Stock Options - - Medical, Dental and VisionBenefitsfor Employee and Dependents - - 401(k) Plan - - FSA Medical and Dependent Care Plan - - Flexible PTO Policy - - Employer-Paid Life, Personal Accident and Disability Insurance - - Employee Assistance Program - - Referral Program - - Pet Insurance - - Student Loan Refinance - - Learning and Development Programs - We are an Equal Opportunity Employer M/F/D/V/SO and a great place to work. - Thank you for considering this opportunity at NephroSant. If this role sounds exciting, we would like to hear from you! - We are unable to sponsor work visas at this time.

Keywords: Nephrosant, San Mateo , Clinical Affairs Associate/Senior Associate, Healthcare , San Mateo, California