Sr. Clinical Research Associate

Responsibilities

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

Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately

Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed

Oversees aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision

Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed

Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes

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

Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables

Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows

Participates in the development, distribution, review, and tracking of essential trial documents

Strives to ensure timelines and deliverables are met within budget

Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes

Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution

Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review

Liaises internally to forecast and monitor overall drug supply throughout the trial

Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality

Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions

Contributes to the SOP review process and/or other Clinical Operations Initiatives

Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits

Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done

Benefits

Annual performance incentive bonus

New hire equity

Ongoing performance-based equity

Medical, dental, and vision insurance

401k match

Unlimited PTO

A number of paid holidays including winter shutdown

Structure Therapeutics specializes in the discovery and development of drugs against a type of targets called GPCR.

South San Francisco, California, USA

https://structuretx.com/

Public Company

Total Funding

$1.77B

Key Investors

Biotechnology Value Fund

Qiming Venture Partners

2025-12-09

Post Ipo Equity· $747.5M

2024-06-05

Post Ipo Equity· $547.4M

2023-09-29

Post Ipo Equity· $300M

Leadership Team

Raymond Stevens

Chief Executive Officer

Jun Yoon

Chief Financial Officer

Recent News

MarketScreener

Structure Therapeutics Reports Up to 16.2% Weight Loss in Aleniglipron Trial

Qualifications

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. 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

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

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

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

Required skills

Clinical trial management, Drug development process, ICH guidelines, Clinical Practice (GCP), Standard Operating Procedures (SOPs), Medical terminology, Microsoft Office, Clinical monitoring, Protocol development, Case Report Form (CRF) design, Trial Master File (TMF) management, Prioritization

Preferred skills

Planning skills

Experience

4+ years