Provide local support for clinical trial supply coordination, if applicable. Ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
Collect, review, process, and track regulatory & investigator documents required for effective and compliant study site activation.
Ensure that all assigned start up activities are on track and support study deliverables.
Proactively manage sites to ensure timely site activation. Participate in team meetings to progress trials and identify site issues that might impact the timelines.
Escalate study issues appropriately and in a timely fashion.
When needed, assist in preparation of Site Activation project specific plans. Provide accurate projections and timelines to study teams agreed with Sponsor.
Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol.
Review and update study documents when there are changes in study personnel/study amendments.
Liaise with Covance Regulatory department regarding document submission requirements, if applicable.
Proactively resolve informed consent issues and other potential difficulties with study sites.
Prepare submissions to IRB/IEC, and regulatory authorities if GRS requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/approval issues.
Ensure high quality site documents are filed in the (e)TMF in a timely manner according to study plans.
Negotiate site contracts and budgets with sites, if applicable. Proactively track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
Undertake tasks delegated by senior team members, depending upon country and situational requirements.
Perform other duties as assigned by management.
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.
Minimum of 2 years of experiences in clinical development or regulatory process. Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites. Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.