Clinical Project Associate
Clinical Project AssociateAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:As a member of the Allakos team you will have the opportunity to supports the Allako Clinical Operations team by providing clinical project assistance and documentation support for all clinical studies. The position requires a highly-motivated 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 clinical trial objectives, regulatory submissions, inspections and corporate goals. This position reports to the Clinical Project Administrator. This position is remote based with light travel required.
- Clinical Site Billing
- Maintain clinical study site budget master files across multiple studies
- Assist Project Administrators with monthly site activity statements
- Site Metrics/Study Management
- Maintain in-house CTMS functions with real-time study trackers across multiple studies ensuring all information is accurate including site contact details, enrollment metrics, site visits, etc.
- Work with CRAs to ensure monitoring plan is adhered to, including submission of monitoring reports within stated deadlines
- Site startup activities
- Assist Clinical Project Administrator with initial feasibility questionnaires, CDAs, and budgets for potential clinical research sites
- Electronic Data Capture System
- Manage access to EDC systems across multiple studies to ensure appropriate users have access
- Verify EDC users on monthly basis across multiple studies
- Study Site Payment systems
- Manage access to payment systems across multiple studies to ensure appropriate users have access
- Work with vendor to maintain updated payment schedules
- Monitor site enrollment to ensure site has adequate supplies
- Expeditiously address errors as they occur
- Assist with organization of investigator meetings & department meetings as needed
- Generate clinical purchase order requests with finance
- Manage and maintain eTMF document uploads
- Assist with expense reports for upper management
- Participate in weekly team meetings via conference call
- Work with other clinical team members as needed on various tasks
Qualifications and Expertise:Bachelor’s degree preferably in Life Sciences or an equivalent combination of education and applicable job experience may be considered. Prior experience in clinical operations or the healthcare field is a bonus.
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency in MS Office applications
- Self-sufficient and able to work with minimal oversight.
- Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to earn and foster cooperation with and of others.
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
- Willingness and ability to travel as required.