PURPOSE OF JOB:          

Partnering closely with internal and external cross-functional teams, the Clinical Trial Associate will provide clinical administrative coordination to the RAPT clinical project teams, under the direction of the Clinical Trial Manager/Project Team Lead. The Clinical Trial Associate will have the technical ability and drive necessary to support all areas of Clinical Operations activities in pursuit of Clinical Operations Department/Clinical Development goals and objectives.  The Clinical Trial Associate may perform the essential functions independently or provide oversight of third parties as assigned.

MAJOR DUTIES AND RESPONSIBILITIES:

The successful candidate will be responsible for performing or providing Clinical Operations oversight of in-house and outsourced activities in the following areas:

• Provide general coordination support to the Clinical Development Project teams and assistance to Clinical Trial Managers (CTM) and Project Team Leads
• To assist the Clinical Development teams in the completion of all required tasks to meet project goals and Clinical Operations Department objectives
• Participate in and support planning, conduct, management and completion of studies through interactions with sites, vendors, and internal/external team members
• Assist study team members performing site identification, qualification, selection, initiation, monitoring, management, and close out
• Assist with project tracking and project status updates
• Basic knowledge of ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems
• Establish, review, organize and maintain clinical study documentation (e.g., Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival
• Assist with development and management of internal tracking systems as assigned
• Assist with compiling and distributing periodic study summaries as assigned
• Review, file and track study documents collected by the field Clinical Research Associate (CRA), provide document review assistance, and initiate appropriate follow-up as needed
• Assist with managing the ordering/dispatch and tracking of trial materials (e.g. binders, notebooks, lab supplies) as appropriate
• Review Investigator/Site invoices for accuracy and reconcile against the case report forms (CRFs) and budget for payment submission
• Assist with tracking central and local IRB submissions and approval
• Assist with tracking of the collection of required documents during site start-up
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
• Route study documents to the appropriate personnel for validated digital signature
• Distribute, file and track safety reports as delegated by the CTM
• Provide support to the CTM and project team with meeting coordination, agenda preparation and generation of meeting minutes as assigned
• Assist with creating/maintaining required registration on
• Provide support to the clinical team as needed

To accomplish the above, the Clinical Trial Associate will be required to:

• Develop and maintain strong internal and external relationships with key stakeholders
• Effectively communicate with key stakeholders at all levels of the organization
• Quickly and accurately identify issues and escalate to team and assist with development and implement of effective solutions
• Prospectively identify risks and mitigation approaches, and escalate them as appropriate

EDUCATION REQUIREMENTS: 

• Bachelor’s degree or equivalent desired.  Additional clinical research experience may be substituted for educational requirements.      

EXPERIENCE REQUIREMENTS: 

• Up to approximately 2 years of clinical operations experience

• Proficiency with MS Word, Excel, PowerPoint. Outlook and Adobe Acrobat
• Excellent oral and written communication skills
• Strong organizational skills and ability to work on multiple projects often with tight timelines and with minimal supervision
• Detail-orientation with solid time management skills
• Ability and willingness to understand and adhere to job requirements
• Maintain corporate confidentiality at all times

OTHER QUALIFICATIONS:  

• Ability to work on-site at our South San Francisco office 3 days per week

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $106,000 (entry-level qualifications) to $144,900 (highly experienced).