structuretx

structuretx

Sr. Clinical Research Associate (MP)

South San Francisco, California · Senior

Sponsorship not specified$135k-$150kDetected 20 days ago
GCPExcelClinical TrialsClinical ResearchResearchExperimental DesignCommunicationProblem SolvingPublic SpeakingMicrosoft Office

About the role

  • This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives.
  • Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.
  • Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.

Responsibilities

  • CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study.
  • Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level.
  • May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
  • Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.

Requirements

  • Bachelor's degree in a relevant scientific discipline
  • Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting.
  • Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
  • Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.
  • Proficiency in Microsoft suite or products such as Word, Excel etc.
  • Travel Required: Up to 20%
  • Education
  • Experience
  • Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus.
  • A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
  • Self-motivated and able to motivate others.
  • 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 $135,000 - $150,000. 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

  • Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills

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 $135,000 - $150,000.
  • 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 Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This role will report to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
  • 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.
  • Clinical Research Associate (Sr.

Visa & Work Authorization

  • Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting
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