The CTA will assist with clinical trial planning and execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
Location: Bothell (Seattle), WA or Remote anywhere is the US.
- Support the Clinical Operations teams in study start up, execution, and close out.
- Provide general administrative support to the clinical operations team and may function as a central contact for designated project communications, correspondence, and associated documentation.
- Create and/or maintains various clinical tools such as use of electronic CTMS systems or other electronic software/cloud systems to track data including, but not limited to study enrollment, study team contact lists, study team training, IRB applications, consent/re-consents at site, IP shipment tracking and laboratory sample tracking.
- Assist with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study related team trainings, or other presentations as assigned.
- Preparation of clinical operations meeting minutes.
- Collaborate with Clinical Trial Managers, Clinical Research Associates, and Contract Research Organizations (CRO) to support ongoing trial monitoring activities.
- Ensure Inspection Readiness by managing the set-up, maintenance, and quality control of the internal Trial Master Files (eTMF) and overseeing the CRO's management of Trial Master Files.
- Manages the Clinical Operational internal document filing system and documents.
- Contributes to the preparation of trial-related materials (Clinical Protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals, Diaries, CRFs).
- Assist project teams with study specific documentation and guidelines as appropriate.
- Assist in the coordination and tracking of IP supply, lab supplies, and clinical research specimen shipments.
- Assist with tracking of IP supply at depo and clinical sites and escalates any issues to management.
- Responsible for tracking the inventory of clinical research specimens.
- Assist with planning, preparation, and on-site support of investigators meetings.
- Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials.
- Coordinate logistics for clinical project meetings and preparation and distribution of meeting minutes.
- Ensure timely completion of study tasks and update trial trackers on an on-going basis.
- Generate and distribute study newsletters.
- Maintain version and quality control of study documentation and submit to TMF.
- Proactively identify, triage, and coordinate resolution of clinical study issues.
- Assist with ensuring Clinical Operations Team is up to date on ICH GCP regulations and revisions.
- Assist in quality control audits of clinical study documentation (e.g., Sites regulatory binder, source documentation, Monitoring visit reports, etc.).
- Assist in reviewing data entered in EDC by comparing to source documents, issuing, and resolving queries in EDC.
- Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
- Assist in coordination of Investigator payments or resolving discrepancies, if applicable.
- Assist in the tracking and distribution of safety reports.
- Coordinate document translation with assigned vendor, if required.
- Assist with the coordination of team member training tracking.
- Actively participate in process improvement.
- Other duties as assigned.
- Degree in Nursing (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine required
- CCRA/CCRP certification preferred
- Minimum of 2+ years' experience in clinical research or another regulated environment. Prior experience in small biotech environment, CRO and/or clinical vaccine research clinical site is highly desirable.
- Understanding of clinical trial site monitoring desired.
- Thorough understanding of ICH, and GCP regulations, guidelines, policies, and practices for conducting clinical trials.
- Knowledge of FDA 21 CFR Part 11 for Handling of Electronic Records.
- Strong working knowledge of medical/scientific terminology.
- Prior experience of clinical trial e-systems preferred (e.g., EDC (Electronic Data Capture), eSource, eISF (Investigative Site File), and/or CTMS systems preferred.
Knowledge, Competencies and Skills
- Excellent oral and written communication skills; ability to communicate effectively with co-workers and clinical site personnel.
- Proficiency in MS Office [Excel, Word, PowerPoint,] and Adobe Acrobat. Experience with project management software or cloud systems (i.e., Smartsheet or Airtable) a plus.
- Ability to work autonomously and multi-task in a fast-paced environment.
- Ability to act with integrity, professionalism, and maintain confidentiality.
- Strong attention to detail and accuracy.
- Ability to always maintain and exhibit discretion when handling confidential information.
- Able to travel as required by projects (approx. 10% time as needed: US and international).
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.