Covance Clinical Research Assistant in Moscow, Russia

Job Overview

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

We are currently seeking a pro-active Clinical Research Assistant to join our expanding CoSource team in Moscow, Russia.

Responsibilities:

  • Trial and site administration:

o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

o Clinical supply & non-clinical supply management, in collaboration with other country roles

o Manage Labeling requirements and coordinate/sign translation change request

  • Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents

o Assist with eTMF reconciliation

o Updating manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Execute eTMF Quality Control Plan

o Obtain translations of documents

  • Regulatory & Site Start-Up responsibilities:

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

o Obtain, track and update study insurance certificates

o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

o Publish study results for GCTO and RA where required per local legislation

  • Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

o Develop country and site budgets (including Split site budget)

o Tracking, and reporting of negotiations

o Maintenance of tracking tools

o Contract development, negotiation, approval and maintenance (e.g. CTRAs)

o Update and maintain contract templates (in cooperation with Legal Department)

o Payment calculation and execution (investigators, vendors, grants)

o Ensure compliance with financial procedures

o Monitor and track adherence and disclosures,

o Budget closeout.

  • Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Education / Qualifications

Required:

• University/college degree (life science preferred), or

certification in a related allied health profession from an

appropriately accredited institution (e.g., nursing certification,

medical or laboratory technology)

• In lieu of the above requirement, candidates with one (1) or

more years of relevant clinical research experience in

pharmaceutical or CRO industries may be considered

Experience

Required:

• Basic understanding of biology and biological processes

• Good organizational and time management skills

• Good communication skills, oral and written

• Exhibit general computer literacy

• Works efficiently and effectively in a matrix environment

• Fluent in local office language and in English, both written and

verbal

Preferred:

• One (1) or more years of experience in a related field, (i.e.,

medical, clinical, pharmaceutical, laboratory, research, data

analysis, data management or technical writing)

THERE IS NO BETTER TIME TO JOIN US!

Job Number 2018-20631

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.