About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Associate Director, Clinical Trial Operations is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical operations and monitoring, inspection readiness and IRB/EC submissions of Coderas clinical trials according to Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Associate Director, Clinical Trial Operations will interface with Site Directors and the study team to support operational aspects of study start-up and execution.

Essential Duties and Responsibilities

• Support the execution of Phase I-IV studies including study start-up, site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans
• Prepare and manage potential investigator site lists, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions
• Communicate with investigators and site staff on issues related to feasibility, essential document collection and local IRB/EC submissions.
• Support study start-up activities including the facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals and essential document approvals for IP release
• Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency
• Support study start-up by performing primary or secondary reviews of Essential Document Packages and completing Investigator background checks
• Assist with development and distribution of study materials (e.g. ISF binder), tools and documents
• Responsible for oversight of the central IRB/EC
  • Prepare and submit required study documents to central IRB/EC
  • Support central IRB/EC annual reviews and study updates
  • Communicate with central IRB/EC as needed
• Support site and local IRB/EC annual reports and updates, as needed
• Assist with the facilitation of the site contract and budget process
• Manage translation of necessary documents through translation vendor
• Support creation of and updates to study translation plan
• Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare).
• Facilitate and track vendor system access requests.
• Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy
• Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF)
• Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
• Assist with development and management of ancillary study site supplies such as ISF binders, patient facing materials, patient welcome kits or study related site materials
• Assist with oversight of study site training
• Support inspection preparedness and study/site audit and/or inspection activities, as needed
• Execute other duties as assigned

Qualifications

• Bachelors Degree with minimum 5 years of relevant clinical trial experience required
• Experience with feasibility and study start-up
• Experience and proven proficiency in CTMS and eTMF systems
• Experience with Veeva Systems preferred
• General knowledge of clinical site monitoring, feasibility and study start-up preferred
• Detail-oriented, organized, and committed to quality and consistency
• Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
• Excellent team-interaction skills and ability to work successfully in global team settings
• Ability to work in a dynamic environment with a high degree of flexibility
• Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment
• Must be proficient in Microsoft Word, Excel, and PowerPoint

Codera, LLC is an equal opportunity Employer. Codera, LLC is a an E-Verify employer.