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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

Responsibilities/Duties:

* 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.

Experience

* 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



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