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.
Job 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.
- 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., www.clinicaltrials.gov, 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.
Qualifications:
Education
- Bachelor's degree in a relevant scientific discipline
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
- 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.
Travel Required: Up to 20%
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.
