structuretx

structuretx

Sr. Clinical Trial Assistant - Bay Area (CN & JS)

South San Francisco, California · Senior

Sponsorship not specified$110k-$120kDetected 20 days ago
JavaScriptExcelClinical TrialsFDA RegulatoryCommunicationOrganizational SkillsRegulatory Affairs

About the role

  • Facilitate with the preparation of agendas and takes comprehensive minutes for internal and external meetings.
  • Accountable for study level tracking as assigned, e.g. monitor visit tracking, sample tracking, study related supplies etc.
  • Assists in preparing materials for investigator meetings, monitor workshops, and study manual.

Responsibilities

  • Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
  • Sets-up and maintains/ closes out the Trial Master File (TMF/eTMF), perform QC as assigned and resolves discrepancies.
  • Maintain and update study metrics as necessary, including, but not limited to: Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, etc.
  • Communicates and coordinates with team members to ensure accurate and comprehensive completion of documents by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines.
  • Update and maintain public clinical trial listings/postings (e.g., www.clinicaltrials.gov, EUDract registry, etc.).

Requirements

  • Bachelor's degree in a relevant scientific discipline
  • 2+ years with biotechnology/pharmaceutical/clinical trial management experience.
  • Proficiency in Microsoft suite of products such as Word, Excel etc.
  • Travel Required: Up to 20%
  • Assist with data reconciliation, as required.
  • Education
  • Experience
  • 2+ years with biotechnology/pharmaceutical/clinical trial management experience. Global experience a plus.
  • Familiarity with document filing/management in an eTMF environment Excellent communication and interpersonal skills
  • Ability to efficiently perform multiple tasks and manage changing priorities.
  • Structure Therapeutics Inc. is an Equal-Opportunity Employer.
  • Structure 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 $110,000 - $120,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
  • At Structure, 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. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Nice to have

  • Global experience a plus.

Skills

  • Participate in the review of clinical data in the clinical database, data listings, and reports, as assigned.
  • Effective organizational skills and a high regard for attention to detail

Compensation

  • Structure 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 $110,000 - $120,000.
  • At Structure, base pay is only one part of your total compensation package.

Benefits

  • The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
  • Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Company info

  • Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
  • Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
  • Position Summary:
  • The Senior Clinical Trial Associate (SCTA) acts as a central contact for the designated clinical study team and in this key support role supports the team in the planning, implementation, and completion of clinical studies both outsourced or in-house, through interaction with investigative sites, vendors, and team members. The SCTA, under the direction and guidance of team members will work independently but knows when to involve and or collaborate with other functional members in the execution of role & responsibilities.
  • Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology.
  • The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
  • We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
  • Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors.
  • The company completed an initial public offering (IPO) in February 2023.
  • With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
  • The Senior Clinical Trial Associate (SCTA) acts as a central contact for the designated clinical study team and in this key support role supports the team in the planning, implementation, and completion of clinical studies both outsourced or in-house, through interaction with investigative sites, vendors, and team members.
  • The SCTA, under the direction and guidance of team members will work independently but knows when to involve and or collaborate with other functional members in the execution of role & responsibilities.
  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
  • At Structure, base pay is only one part of your total compensation package.
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