Clinical Trial Associate/Sr. Clinical Trial Associate

About Mineralys Therapeutics

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is initially developing for the treatment of patients with uncontrolled hypertension. Mineralys Therapeutics is based in Radnor, PA, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter.

The Role

The Clinical Trial Associate/Sr. Clinical Trial Associate (CTA/Sr CTA) performs tasks related to operational strategy in support of study management from start-up through closeout. The CTA/Sr CTA is responsible for assisting and providing support to the members of the Clinical Operations team (Clinical Trial Managers, Clinical Research Associates, and Medical Monitors). This position requires prior experience or training in clinical research and GCP/ICH guidelines. Under general supervision, this person assists with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned.

What you will do:

• Contribute to the creation and/or review of, and distribute and track Study Reference Materials e.g., Study protocol, Study Reference Manual, Pharmacy Manual, Monitoring Plan, TMF Plan, Informed Consent Form, site and study training materials.
• Manage the oversight of sample collection and analysis (e.g., lab samples, PK samples)
• Provide support for day-to-day study activities in accordance with established protocols under the general guidance of the assigned Clinical Trial Manager
• Help manage external vendors by setting up meetings, taking minutes, proactively communicating, and responding to requests.
• Contribute to building a culture of team, site, and patient centricity
• Specification process and UAT.
• Demonstrates working knowledge of clinical research conduct, laws, regulations, and standards, and complies with applicable SOP's and policies
• Assist with distribution, collection and tracking of regulatory documents (e.g., confidentiality disclosures, IRB approvals, and financial disclosures) to/from study sites.
• Coordinate IP-handling processes including initiating shipments and returns, tracking inventory at sites and assisting with IP reconciliation.
• Support in the review of CRFs, including participating in the EDC and RTSM
• Maintain study site information, track IP, ancillary product inventory, track clinical study-related documents, and subject follow-up schedule and visit status, as required
• Support the Clinical Operations team in the successful execution of assigned clinical trials from protocol concept through to clinical trial report, in compliance with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
• Support the planning of Investigator Meetings and/or Site and CRA trainings as required
• Provide input on and distribute recruitment and other research subject facing study materials.
• Support in the review and tracking of invoices from vendors/consultants as per contract
• Under direction of the Clinical Operations team, perform clinical trial activities for ongoing and new clinical trials (local or global) including, status report and metric generation, maintenance of: Investigational Product (IP) and regulatory document tracking systems, and files required regulatory documents, and the Trial Master Files (TMFs)
• Under the direction of the Clinical Trial Manager review and track Site selection/Visit reports: Qualification Visits, Initiation Visit Reports, and Interim Monitoring Visit Reports
• Assist with preparation of reports (management reports, regulatory reports, etc.), as required.
• Assist with archiving study documents for completed clinical trials

What you will bring:

• Experience collaborating successfully across multiple teams and levels
• Strong written and verbal communication skills
• 2 – 5+ years’ experience within the Pharmaceutical-biotech industry
• Regulatory requirements
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other
• Experience working in a team across multiple functional areas (e.g., work
• Bachelor’s level degree in life sciences, pharmacy or nursing preferred
• Experience in Phase 2 or Phase 3 studies and global studies is an asset
• Must be flexible, adaptable, proactive, and work well under pressure
• Quality Assurance, Data Management, Safety, Medical, Project Management