Document Review Specialist I at Covance

Job description

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We are recruiting for our Global Site Services team in EMEA region and are currently seeking to hire a Document Review Specialist to help support the team with reviewing study related documents. This is a permanent, full time, office based position. For Experienced, fully independent Specialists there are also home-based options available.

About The Job
Responsibilities/Duties :

Being responsible for the review of documentation for a clinical trial (study protocol, informed consent form, patient documents, site documents) to grant authorization for patient recruitment at a hospital.

Main Tasks

• Review and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan

• Preparation of project specific plans for the DocRev component of assigned studies
• Review of core English patient informedconsents for compliance to international requirements and protocol as applicable

• Review of core Country patient informed consents for compliance to country requirements and protocol as applicable
• Maintain and update document tracking information in CTMS and other tracking logs

• Assess impact of study amendments on Informed Consent and other study documents and revise and review accordingly

Required

About You

University/College degree (life science preferred), or certification in a related allied health profession from an 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.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.

Experience

• Experience on a similar position or previous Study Start-Up/CRA Experience preferred
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
• 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 trial strategies
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in a team environment
• Detail and process oriented
• Positive attitude and approach
• Multi-tasking capability
• Ability to work independently

Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.