Senior Clinical Research Associate (In-House) Job at Vera Therapeutics
Title: Senior Clinical Research Associate (In-House)
Location: Brisbane, California or Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
We seek a highly skilled and motivated Senior Clinical Research Associate (In-house) to join a fast-paced and collaborative team. The Senior Clinical Research Associate will be responsible for the in-house day-to-day operational activities for the successful execution of a clinical trial(s).
Responsibilities:
- Leads or supports clinical operational components of global clinical trial management and site management during start-up, conduct and close out activities
- Works with internal and external team members to provide study assigned deliverables
- Provides study tracking (site status, subject status, etc.); generates, reviews, and distributes study management reports to the team at requested intervals
- Leads development of study specific plans and/or processes, and study materials (ICFs, study plans, Pharmacy Manuals, etc.)
- Provides support as the Sponsor oversight for the review of the TMF
- Leads specific tasks such as TMF review, monitoring report review or non-CRO vendor oversight or regional CRO oversight
- Coordinates Investigator Meetings (as applicable)
- Coordinates with meeting logistics (internal meeting agendas/minutes, review of CRO meeting minutes, etc.) as needed
- Supports or assists with tracking and management of vendor budgets
- Participates in development opportunities for the department (SOP review, initiatives, etc.)
- Mentors junior team members as needed
- Develops and maintains strong working relationships with study vendors as well as site staff
- Develops strong cross-functional relationships within the organization.
- Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines
- May travel up to 30%, as needed, to support clinical development programs
Qualifications:
- BS or higher in life sciences or health-related field.
- Minimum of 2 years in CRA role/clinical trial support role
- This position requires candidates to come into the Brisbane, CA office, at least once a week.
- Rare disease, inflammatory diseases and/or difficult enrolling study experience preferred
- Proven ability to operate in a fast-paced start-up environment.
- Ability to work independently as well as cross functionally and handle multiple priorities while paying attention to detail
- Proven flexibility and adaptability
- Working proficiency of GCP, ICH guidelines and FDA regulations.
- Proficiency with MS Office (e.g., Word, Excel, PowerPoint, Outlook, Project)
- Extremely organized with strong interpersonal skills with excellent oral and written communications
- Ability to travel up to 30%
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $135,000.00 - $162,000.00. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s qualifications, skills and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies:
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
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