Clinical Documentation Assistant – Job #1011
Supports the Allakos Clinical Operations team by providing clinical project assistance and documentation support for all clinical studies. The position requires a highly-motivated, detail-oriented individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring excellence in a fast-paced, start-up biotech environment. Overall responsibilities will include support of Clinical Operations systems and processes from study start-up through study closure in support of trial objectives, regulatory submissions, inspections and corporate goals. This position reports to the Clinical Documentation Manager. This position could be based in Redwood City, or Texas. If employee lives in Texas, travel to California will be required for approximately 1 week every 6-8 weeks.
- Trial Master File Administration
- Set up study sites in Veeva Vault eTMF
- Assign document collection and training tasks to eTMF users
- Create study milestones and Expected Document Lists
- Complete User Acceptance Testing for system updates
- Regulatory Documentation
- Collaborate with research sites to collect required essential documents
- Coordinate with Clinical Research Associates to collect unanticipated documentation from sites (e.g. correspondence, notes to file, memos, etc.)
- Collect Central Trial Documents from the study project managers and other trial team members.
- Collect documents from central IRB online portals
- Ensure quality of all documentation
- Upload study documents into eTMF
- Reconcile documents at end-of-study
- Study Metrics
- Generate and distribute pending document reports to trial team
- Track training for clinical study team
- Participate in monthly on-site meetings with clinical team at Headquarters in Redwood City, CA
- Work with other clinical team members as needed on various tasks
Qualifications & Expertise:
Bachelor’s degree preferably in Life Sciences or business; an equivalent combination of education and applicable job experience may be considered. Prior experience in clinical research is a bonus.
- Excellent verbal and written communication skills as well as interpersonal and organizational skills.
- Proficiency in MS Office applications.
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to firstname.lastname@example.org and reference Job #1011
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.