**Job Description:**
Develop project specific plans for the Global Site Services 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 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 to Local and/to 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 experienced 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
**Requisition ID:** 61786BR
**Job Category:** Clinical Research
**Locations:** Japan - Tokyo
**Shift:** 1
**Job Postings:** Develop project specific plans for the Global Site Services 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 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 to Local and/to 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 experienced 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
**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.
**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
**EEO Statement:**
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.