Covance Start-Up Specialist I in Buenos Aires, Arkansas
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, IRBIEC 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.
University / College Degree ( life science preferred) , or cortication in a related allied health profession from the appropriate accredited institution (e.g nursing certification, medical or laboratory technology) and 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
Strong networking abilities and an ability/ willingness to work with internal and external stakeholders across the globe
Good organizational and time management skills
Excellent communication /writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review / analyze relevant data so as to assist in building evidence-based clinical trials strategies
Self-motivated with ability to work under pressure to meet deadlines
Work well independently as well as in team environment
Detail and process oriented
Positive attitude and approach
Ability to work independently
Job Number 2018-20977
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.