Job Code: USCO01
Position: Clinical Trials Specialist
Department: Clinical Operations
Reports to: Associate Director, Clinical Operations
Location: San Francisco (Bay Area), possibility for remote
Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research. With operations and expertise in China, the United States and Australia and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.
We are seeking a motivated, self-starter for a clinical trials specialist position in our company. You will be responsible for keeping track of clinical project budgets based on established work orders, managing vendor invoices from receipt through approval for payment, filing and maintenance of clinical trial documentation and helping to coordinate internal project meetings and communications and other duties, as needed.
The clinical trials specialist will report to the Associate Director of Clinical Operations. You will work closely with the project teams, therefore strong communications skills are a must. Your mission is to help the Clinical Operations Department meet quality standards and deliver clinical trial results on time and within budget.
- Review of CRO clinical site monitoring reports and follow up on any outstanding issues to resolution
- Perform period audits of the Trial Master Files to ensure completeness and audit-readiness
- Work with internal regulatory contact quarterly to review and update ClinicalTrial.gov study listings and internal Connect study and site tracker
- Assist project managers with administrative duties and processes.
- Track clinical trial budgets and project expenditures based on established work orders.
- Manage vendor invoices from receipt through approval for payment in the company’s Accounting/Finance system and working with Accounting to ensure invoice payments are paid on time
- Filing and maintenance of clinical trial documentation in Sharepoint and maintain compliance regulations.
- Assist with the set up internal project meetings and document meeting discussions, if needed, and prepare and distribute project materials.
- Collaborate on the preparation of project presentations.
- Foster positive relationships across departments and encourage frequent communication.
- Occasional local travel (within US) may be required.
- Willing to work occasional late evenings and early mornings and willing to attend occasional regional team meetings outside standard business hours.
- Two years of related experience
- Excellent interpersonal skills and ability to build and maintain positive working relationships to effectively interface at all levels across the organization.
- Excellent communicator with business acumen and the ability to consistently meet or exceed project deadlines.
- Excellent writing, organizational, problem solving, and analytical skills.
- Detail-oriented and comfortable executing on multiple projects independently and in collaboration with others
- Financial, accounting and contracts experience a plus
- Computer literate, experience with MS Office and Sharepoint a plus
- Self-directed, proactive, and able to work independently from a home-based office
- Bachelor’s degree required (in science, public health, project management or business is preferred)