Description
Position Summary
The Temporary Clinical Project Associate (CPA) provides essential operational support to Clinical Operations across study start-up, conduct, and close-out in a small, fast-paced sponsor environment. The CPA ensures documentation and systems accuracy, timely task completion, and inspection readiness while partnering closely with sites, vendors, and cross-functional teams. This position reports to the Senior Director of Clinical Operations or Associate Director of Clinical Project Management and Outsourcing.
This is a temporary position with the potential to transition into direct-hire in the future.
Responsibilities
- Assist in the tracking and oversight of start-up activities, including feasibility, site activation packages, submissions, and essential document status; maintain timelines and trackers to support on-time activation.
- Supports clinical document control activities and associated quality checks to ensure the Trial Master File (eTMF/TMF) is current and inspection-ready.
- Coordinate execution of, and provide administrative support for, vendor and clinical site contracts in accordance with study timelines.
- Review vendor invoices to ensure alignment with contract terms and study milestones; route for approvals and track to payment.
- Utilize strong analytical skills to assess issues and propose solutions; escalate risks with recommended mitigations.
- Coordinates and manages tasks with other sponsor functions to achieve site readiness and address operational blockers.
- Maintains accurate, current entries in eClinical systems (eTMF—ideally Veeva Vault, CTMS, EDC, IRT, eCOA) and reconciles across systems as needed.
- Prepares study metrics, dashboards, and routine status reports; supports governance read-outs with clear data summaries.
- Schedules and facilitates study meetings; drafts agendas, captures minutes and action items, and drives closure of deliverables.
- Supports creation, formatting, and version control of operational documents (plans, logs, trackers, site tools) in alignment with SOPs.
- Coordinates communication with sites and vendors; tracks issues, queries, and decisions to timely resolution.
- Supports clinical supply, PV, Biometrics, and Regulatory handoffs by maintaining accurate logs and ensuring document/system completeness.
- Supports risk management initiatives (issue/risk/decision logs) and contributes to CAPA follow-up activities.
- Supports audit/inspection activities as needed, including evidence collection and TMF spot checks.
- Supports clinical trial registry entry/updates, as required (e.g., ClinicalTrials.gov).
- May contribute to department infrastructure initiatives and continuous improvement of processes and tools.
Minimum Qualifications
- BA/BS in a relevant scientific discipline with 3+ years of clinical research experience at a site, CRO, or sponsor. Strong preference for hands-on site/CRC experience (e.g., informed consent, source, EDC, query management). A combination of relevant education and applicable job experience may be considered.
- Proficiency with Microsoft 365 (Outlook, Teams, SharePoint, PowerPoint, Excel including pivots and lookups); ability to create and maintain trackers and reports.
- Comfort with eClinical systems (eTMF—ideally Veeva Vault, CTMS, EDC such as Rave/Medidata, IRT, eCOA) and ability to learn new tools quickly.
- Working knowledge of ICH GCP and applicable regulations; strong Good Documentation Practices.
- Outstanding verbal and written skills with the ability to understand and present technical information effectively.
- Performs independently and professionally with sound judgment; applies learnings across multiple protocols, sites, and therapeutic areas.
- Possesses effective time management, organization, attention to detail, interpersonal, conflict management, and problem-solving skills.
- High sense of accountability and urgency; able to handle multiple tasks simultaneously in a changing, high-pressure environment.
- Works effectively in a matrix, cross-functional, global setting; able to establish and maintain culturally sensitive working relationships.
- Works with a high quality and compliance mindset.
Location
Fully Remote (Travel 10-15%)#LI-REMOTE
Clinical Project Associate hourly range: $35.00 to $42.00The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the years of relevant industry experience, education, and skills/abilities.The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/Disability/Vets Employer and an E-Verify Company