Study Start-Up Specialist
Your tasks and responsibilities
The primary responsibilities of this role, Study Start-Up Specialist, are to:
- Contributes to the Feasibility process by collaborating with CRA level III (Sr. CRA) to proactively establish lists of new clinical sites to prepare for upcoming pipeline. Track new potential investigators in collaboration with CRA level III (Sr. CRA).
- Proactively initiate any start-up activities as appropriate e.g. CDA, gather site specific information, and assist in driving potential master investigator agreements in conjunction with the Contract and Budgets group, etc. in order to prepare for any upcoming trials.
- Provides business intelligence (on site
start-up capability) and recommendation on site selection during
local feasibility and study kick off meetings including providing
recommendation on study/site start-up timelines.
Collaboration with External and Internal Stakeholders:
- Establishes relationships and collaborates with government agencies or other such agencies on an ongoing basis regarding ethics processes.
- Provides feedback to ethics agencies on an ongoing basis to facilitate further improvement in the provincial based centralized ethics process for institutions;
- Facilitates working relationships and expedites national central IRB process for any non- institution sites
- Keeps current with the provincial requirements for central ethics and policies governing study start-up
- Collaborates, motivates, drives and ensures that all internal stakeholders (Regulatory, contracts and budgets, CLMs, legal) and site staff are working towards agreed timelines for study-start up activities and to resolve any start-up related issues
- Acts as Start-up lead to strategically assess sites within and across provinces to gauge site’s ability and priority for start-up.
- Advises and aligns local study team accordingly to ensure expeditious start of all sites within the trial across multiple trials
- Collaborates and problem solves with
internal stakeholders (Regulatory, Legal, Contracts and Budgets,
Procurement, PV) and sites to ensure all documents are completed
and are in compliance with ICH/GCP/legal requirements/Health Canada
and Bayer SOPs. This
- Completion of Country Informed Consent Form (ICF) per ICH guidelines/research ethics requirements
- Central or site Ethics Committee approval: managing online submission and approval process
- Clinical Trial Application (CTA) process
- Contracts & budgets; Confidentiality agreements
- Ensure all areas of study start-up on the critical path are successfully addressed for each trial e.g. ethics review/approval, CTA and contracts and budgets
- Collects and reviews content of green light documents and collaborates with Clinical Trial Support Coordinators (CTSC) to ensure documents are tracked and filed in the eTMF
- Updates Study Start Up fields in IMPACT for reporting metrics
Reporting and Process Improvements:
- Presents study start-up status of each trial during project review meetings
- Collects and analyzes metrics for presenting recommendations to Site Management Leadership Team to improve start-up timelines and takes corrective and preventative action as necessary
- Shares best practices among the Start-up unit; ensures continuous process improvements
Who are you
Your success will be driven by your demonstrations of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possess the following:
Who you are
- Bachelor’s degree (in health Sciences)
- 3 to 5 years working experience in clinical trials
- Strong knowledge of drug development, clinical trial processes and ethics review processes as well as requirements.
- Demonstrated knowledge of ICH/GCP
- Strong planning, communication & problem solving skills with creative solutions
- Strong ability to drive and align people to achieve results
- Analytical skills for preparing and presenting metrics
- Excellent collaboration and interpersonal skills
- Proficiency in Microsoft Office
Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.
Location: Mississauga, Toronto
Functional Area: [sap_fa_16]
Entry Level: 5