Covance is seeking a Start-Up Specialist to join our team in Buenos Aires, Argentina.
Come work as a Start Up Specialist I at the top Clinical Research Organization. We offer great benefits with opportunities to grow and learn alongside accomplished professionals. This is a full time, office based position with a competitive salary and benefits.
The Company - COVANCE
As one of the world's largest and most comprehensive drug development services companies, Covance has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today.
We are currently seeking a Start-up Specialist to join our Clinical Operations team. The ideal candidate should have familiarity with investigator start up documents, previous interaction with operational project team/investigative sites and working knowledge of ICH, FDA, IRB/IEC guidelines.
Overview: Serve as a liaison between Sponsor, investigative sites and Covance. Negotiate contracts and budgets with investigative sites; and collaborate with internal project team to ensure negotiations occur within timelines.
- Deliver Start-up component of assigned studies within the country or globally. Including accountability of delivery time, cost and quality for assigned activities.
- Primary contact with investigative sites during the site start-up activities
- Responsible for working with investigative sites to collect the required investigators and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.
- Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization and conduct of global clinical trials
- Where applicable, provide logistical support of clinical trial supply coordination
- Develop Project specific plans for Startup component of assigned studies
- Liaise with Operational Project Teams regarding project issues
- Collect, review, approve process and track regulatory & investigator documents required for study activation in accordance with SOPs, GCP ICH Guidelines and Investigator Package Plan
- Review and Approve cre English patient informed consents for compliance to international requirements and protocol as applicable.
- Review and approve core Country Patient informed consents for required elements
- Resolve informed consents and contractual language issues for exercising advance judgement when interacting with study sites
- Negotiate contract and budget with investigative sites
- Liaise with Sponsor and Covance regulatory regarding document submission requirements
- Maintain and update documents tracking, site address and contact information in the site Information
- Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process / review/ approve new documents according to GCP/ICH guidelines
- Assess impact of study amendments on Informed Consent and other study documents and revise and review / approve accordingly
- Prepare new investigator submission package s to Local and / or Central IRB/ IEC
- Attend ongoing training in GCP, project specific requirements and as may generally be required
- Provide milestone information for incorporation into weekly analysis sheets
- Monitor performance of Start-Up team with regard to project timelines, etc.