Job Description
This is a permanent, full time position and hired person will be working office based in Riga (Latvia).
Responsibilities:
• Collect, review, process, 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
• Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger
• Assist in preparation of project specific plans for the GSS component of assigned studies
• Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable
• Assist in reviewof core Country patient informed consents for compliance to country requirements and protocol as applicable
• Assist in review of investigative site specific patient informed consents for required elements
• Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs
• Assess impact of site personnel changes on regulatory documents and process/review new documents according to GCP/ICH guidelines
• If requested, also take responsibilities as Clinical Research Associate activities in indicated trial
Requirements
Education/Qualifications:
• 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 3 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.
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
• Detail and process oriented
• Positive attitude and approach
• Multi-tasking capability
• Ability to work independently
Company offers
We Offer:
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.
There is no better time to join us!
For more information or to apply:
Please visit Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 58325BR, or follow the link
http://careers.covance.com/job-postings/58325BR/gss-specialist-ii
EEO Employer
Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.