- 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.
- 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.
- 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.
- Interfaces with other cross functional groups to coordinate relevant and timely exchange of information / materials as assigned.
- Assist with data reconciliation, as required.
- Participate in the review of clinical data in the clinical database, data listings, and reports, as assigned.
- Update and maintain public clinical trial listings/postings (e.g., , EUDract registry, etc.).
- Assist with clinical trial insurance policies (includes obtaining and reviewing policies for new studies, tracking and renewing expiring insurance certificates, etc.).
- Prioritizes and plans work activities; Uses time efficiently to meet deadlines.
- May be assigned additional responsibilities based on study needs.
- Bachelor's degree in a relevant scientific discipline
- Minimum 2+ years of biotechnology/pharmaceutical/clinical trial management experience. Global experience a plus.
- Familiarity with document filing/management in an eTMF environment Excellent communication and interpersonal skills
- Effective organizational skills and a high regard for attention to detail
- Ability to efficiently perform multiple tasks and manage changing priorities.
- Proficiency in Microsoft suite of products such as Word, Excel etc.
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Sr. Clinical Trial Associate - South San Francisco, United States - Structure Therapeutics
Description
Job Description
Job DescriptionSalary: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 has completed an initial public offering (IPO) in February of 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 Trial Associate 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 Sr. CTA, 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. #hybrid
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
Experience
Travel - 20%
The target salary range for this full-time role is $90,000 - $120,000 + 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.
