Sr. Clinical Studies Associate

Who We Are

Kinnate is a rapidly growing, clinical stage precision oncology company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Kinnate’s mission is to expand the reach of targeted therapeutics by developing products for underserved populations.  With our lead RAF and FGFR programs currently conducting Phase 1 clinical trials, it is a very exciting time to join Kinnate!     In addition to the promising developments in our pipeline, Kinnate is financially strong with approximately $324.9 million of cash, cash equivalents and investments as of December 31, 2021, which is expected to fund current operations, including initiation of multiple registrational studies, into the second half of 2023. Based in San Francisco and San Diego, California, the Kinnate team is composed of drug discovery experts supported by a distinguished group of scientific advisors.

Kinnate is an employee-focused company providing a best-in-class benefits package which includes:  cash salaries and bonuses and equity awards for all employees; employee stock purchase program; unlimited paid time off; annual paid “refresher” days for all employees; annual massage days for all employees; highly subsidized health benefits packages with a wide variety of provider options and minimal to no out of pocket expenses for employees; monthly stipend for employees who elect no health coverage through Kinnate; life and accidental death and disability insurance; company contribution to 401k plan; flexible office and remote work options; free local gym memberships; healthy lifestyle reimbursement program; home office reimbursement program; and commuter and walking/biking benefits. 

For more information, please visit www.kinnate.com.

 

Your Impact at Kinnate

Reporting to the Director, Clinical Operations, the Sr. CSA will be an integral member of the team responsible for executing clinical trials. This role will support study operational activities under the direction of the clinical study lead(s) and will work closely with relevant cross-functional team members as part of their daily work. The ideal candidate will have excellent organizational and communication skills, be able to prioritize effectively and work independently on routine tasks, and be adaptable and comfortable working in a fast-paced environment. The Sr. CSA may be assigned to multiple clinical studies at any given time.

 

Key Responsibilities:

  • Provides support to the operational study team in all aspects of clinical trial execution to ensure that studies are completed on time, within budget, and in compliance with the clinical study protocol, company SOPs and applicable regulations governing clinical trials.
  • Participates in the review and maintenance of the clinical protocol, study plans and other core study documents.
  • Reviews site-level informed consent forms, study budgets, essential regulatory documents, monitoring visit reports, and case report form (CRF) data.
  • Maintains study dashboards, study document repository (Sharepoint), and clinical study trackers.
  • Maintains clinicaltrials.gov and other study registries.
  • Oversees activities related to TMF setup, maintenance, and document filing, and performs periodic review (QC) of the TMF.
  • Supports study lead(s) with oversight and management of CROs and other study vendors. Management responsibilities for certain study vendors may be assigned.
  • Supports study lead(s) with management of study timelines and key deliverables.
  • Supports study lead(s) with accruals reporting and financial tracking.
  • Identifies and communicates issues/risks, along with potential solutions and risk mitigation strategies.
  • Participates as a core member of the Study Management Team.
  • Participates in site visits (SEVs, SIVs, IMVs, COVs) or co-monitoring as required.
  • Works closely with relevant cross-functional team members to support clinical study activities.
  • Approximately 20% travel may be required, consistent with project needs.

 

Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.

 

The Right Stuff


·        Bachelor’s Degree or equivalent, preferably in a scientific discipline or health-related field

·        4+ years prior experience in a clinical operations role or related industry experience

·        Working knowledge of ICH/GCP guidelines and FDA regulations

·        Global oncology clinical trial experience is a plus

·        Demonstrated critical thinking, problem-solving, and negotiation skills

·        Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines

·        Strong interpersonal, communication, and presentation skills

·        Excellent proficiency in software applications required in day-to-day job function


NOTE: This position summary is not intended to be all-inclusive.  Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Kinnate is a science-driven company and we are proud to be responsible members of our communities. Subject to applicable law, we require all of our employees to be fully vaccinated and boosted against the COVID19 virus.

 

EEO & Employment Eligibility

Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.


Recruitment & Staffing Agencies: Kinnate Biopharma Inc. does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Kinnate or its employees is strictly prohibited unless contacted directly by Kinnate’s internal HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Kinnate, and Kinnate will not owe any referral or other fees with respect thereto.

 

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