COVANCE UKRAINE is currently seeking to hire a Clinical Start-Up Speci
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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 (GSS) team in Kiev, Ukraine and are currently seeking to hire a Clinical Start-Up Specialist to help support the team with contacting sites, collecting documents and providing critical data. This is a permanent, full time position, based in our Kiev office.
About the Job
- 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 - 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 - 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
Within this position, your duties will include:
- 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 - Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor - Maintain and update document tracking, site address and contact information in the Site Information module - 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 - Provide milestone information for incorporation into weekly analysis sheets - Monitor performance of GSS team with regard to project timelines - 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
To be successful in this position, you will need to have a 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 5 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
Additionally, you will need to demonstrate:
- 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 - Fluency in Ukrainian and English language- 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
The opportunity to work within an Experience d and highly skilled team. Covance offers a comprehensive benefits package including health cover, contributory pension and a competitive bonus scheme
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.
There is no better time to join us!
Education/Qualifications . Experience . EEO Employer 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.