Remote Clinical Trial Lead

Summary

Join our team as a Clinical Trial Lead and oversee a team of field Clinical Research Associates (CRA) or In-House CRAs, ensuring compliance with country governing agency regulations and ICH-GCP. You will work closely with study Project Management to ensure clinical delivery and execution in line with project contracts.

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology
• A minimum of 5-7 years of field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits)
• A minimum of 1-2 years Lead CRA/CTL experience
• Required Certifications: GCP
• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs
• Good knowledge of therapeutic area assigned
• Strong knowledge of FDA, MHRA or EMA regulations, as appropriate, and ICH GCP guidelines
• Excellent verbal and written communication skills; excellent interpersonal and organizational skills with demonstrated attention to detail
• Familiarity with EDC and CTMS systems
• Ability to meet deadlines, multitasks, and prioritize based on study needs
• Ability to make sound decisions based on available information
• Ability to establish and maintain a good working relationship with site personnel/ colleagues
• Ability to work both in a team and independently
• Ability to facilitate team meetings and teleconferences
• Familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc
• Experience using SharePoint site as a way of managing and organizing documents and work for the role and for the CRA team
• Ability to present at internal study team meeting(s)
• Ability and willingness to travel up to 30%, as needed
• Proficient with Microsoft Office Suite
• Proven ability to handle multiple projects and meet deadlines
• Commitment to excellence and high standards
• Creative, flexible, and innovative team player

Responsibilities

• Participate in the feasibility process, assisting with site selection and overseeing site evaluation activity
• Oversee the conduct of monitoring/co-monitoring activities for site initiation, interim site monitoring, and closeout, in compliance with all governing laws, regulations, guidelines, protocol, and internal SOPs/policies
• Ensure the monitors are adequately trained on the therapeutic area and study requirements and are prepared to train the site staff during the Site Initiation activities and at other times, as necessary
• Identifies site findings with the ability to re-train, place corrective action in place with the site, and follow-up as required
• Assist Project Management with risk assessment and mitigation strategies
• Develop and monitor metrics to evaluate the CRA and site performance (trip report tracking, days on site needed, etc.)
• Review and approve monitoring visit reports
• Lead regular project level CRA meetings and documents meeting minutes
• Co-monitor as required to assist with source data verification, IP accountability and Investigator Site File review, or to provide coaching and manage performance of CRAs
• Prepare study documents such as annotated trip reports and visit report templates, Clinical Monitoring Plan, study specific templates
• SIV training presentation, study operations manual, source data verification plan, laboratory manual and informed consents
• Implement processes for distribution and tracking of SAEs, safety documentation, and pregnancies
• Monitors compliance of these processes
• Help with the planning and participation of Investigator Meetings
• Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation
• Assists in evaluation of vendor performance during conduct of the study
• Maintains clinical monitoring activity tracking information pertaining to the study
• Serve as the point of contact for client related to clinical monitoring activity
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation); assists with maintenance of Trial Master File as needed
• Develop and maintain collaborative relationships to manage study issues and support milestone achievement; convey project information; answer study questions in a timely manner escalate issues to study management as needed; troubleshoots and follows up on study progress; and reviews report data for completeness and accuracy
• Participate in project audits, as necessary, and assist with audit/inspection responses
• Prepares key reports and documents on progress of study for client or internal Project Manager as appropriate
• Assists with identification of out-of-scope activities and escalates to the Project Manager as appropriate
• Assists in driving patient recruitment at sites and participates, in conjunction with site assigned CRAs, on the development of enrollment plans
• Liaises with data management to identify trends in data entry and review