Covance Start-Up Specialist I in Buenos Aires, Arkansas

Job Overview

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.

The Position

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.

Responsibilities/Duties:

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.

Education/Qualifications

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.

Experience

  • 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

  • Multi-tasking capacity

  • 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.