Clinical Research Associate

The Clinical Research Associate is responsible for assisting with the management of clinical studies to ensure compliance with protocols and applicable regulations. They will provide operational support to the clinical trial team to ensure project milestones are delivered on time, with high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. The Clinical Research Associate will support Clinical Trial Managers in all aspects of trial management, including: participation in CRO meetings, ensuring internal TMF documentation is filed appropriately, reviewing SOPs, as well as other activities as appropriate.

• Responsible for tracking start-up progress globally and tracking enrollment, study metrics and patient data.
• Update study dashboards, study trackers and other applicable study documents using EDC and other sources to provide regular updates on trial status.
• Assist Clinical Trial Managers with preparing documentation for trial-related agendas, meetings, data review and presentations as applicable.
• Conduct informed consent form and study budget review for global sites; escalate issues to Clinical Trial Manager and/or Legal as appropriate.
• Responsible for the review of monitoring reports and tracking of action items.
• Attend team and vendor meetings.
• Manage and provide updated contact lists and other study related documents to study vendors.
• Draft Vendor Management Plans as needed.
• Assist with IRT (interactive response technology) system set up for clinical sites.
• Assist with tracking of samples and documents with sites and vendors as needed.
• Manage clinical study documentation (trial master file and study related tracking); add meeting minutes and other documents to Sharepoint as needed.
• Schedule study related meetings.
• Serve as a point of contact between CRO personnel and Fore on study start-up and other activities.
• Assist with the creation and distribution of quarterly newsletters and other study-related documents.
• Interact with Data Management, Clinical Development and other cross-functional representatives as needed.
• Assist with preparation for investigators meetings, site communications/newsletters, and site training activities.
• Support systems and applications as needed.
• Contribute to internal data review.

• BA/BS degree, preferably in scientific or healthcare related field.
• At least 2 years of experience in clinical research role, preferably in oncology.
• CRO and/or study start-up experience preferred.
• Experience in global clinical trials in the U.S. and European Union, with other geographies desired.
• Demonstratable advanced team facilitation skills that consistently foster effective brainstorming and decision making with both internal colleagues and vendors.

• Demonstratable ability to operate independently in an entrepreneurial environment.
• Excellent interpersonal skills and problem solving/decision making skills.
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.

Fore is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.