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Start-up Specialist II, Ukraine

Covance 4/5/2019 6:17:14 PM
JOB ID: 30110 Category: Clinical Study Start Up
Kiev, Ukraine



Job Overview


* Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
* Primary contact with investigative sites during site start-up activities
* Responsible for working with investigative sites to collect the required investigator 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 to develop evidence-based plans for the successful implementation and conduct of global clinical trials
* Where applicable, provide logistical support of clinical trial supply coordination
* Develop project specific plans for the GSS component of assigned studies
* Liaise with operational project team regarding project issues (i.e., participate in team meetings)
* Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
* Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
* Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
* Review and approve investigative site specific patient informed consents for required elements
* Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
* Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
* Liaise with Sponsor and Covance regulatory regarding document submission requirements
* Maintain and update document 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 packages to Local and/ ot 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 GSS team with regard to project timelines
* Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
* Manage set up and maintenance of investigative site files
* Understand and follow project specific and GSS policies and procedures
* Manage the drug supply vendor activities as applicable
* Develop, review and approve drug supply labels as applicable
* Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes
* Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
* Create surveys to probe “thought leaders” and Experience d researchers and clinicians in the field for expert feedback
* Assist with preparation of materials for formal client/industry presentations and for internal training assignments
* Apply basic understanding of data spreadsheets and tables
* Assist with entering data into spreadsheets when required
* Review and audit data tables and spreadsheets for feasibility assessments
* Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals
* Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study Experience , and Investigator self-reported data
* Establish, conduct and maintain relevant QC processes in regards Feasibility Assessments
* Conduct QC of feasibility documents as required by the process
* Undertake literature and internet searches as required
* Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report
* Mentor other GSS team members
* Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles
* Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate
* Perform other duties as assigned by management
* Travel Requirements: <10% travel may be required

Education / Qualifications

Required: 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 proven Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.


* 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

Position Type: Full-Time

Location: Kiev, UKR - Ukraine


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).