- 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 to ensure high quality of data.
- 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; co-monitors as needed for training and quality assurance (QA) purposes.
- Contributes to the case report form (CRF) design process including content, 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.
- Bachelor's degree in a relevant scientific discipline
- Minimum 2-4+ 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 of products such as Word, Excel etc.
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Clinical Research Associate - South San Francisco, United States - Structure Therapeutics Inc
Description
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.
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 Clinical Research Associate (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.#hybrid.
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
TRAVEL
Up to 30%
The target salary range for this full-time role is $110, ,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training.
More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.
