Clinical Trial Lead

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.   

As the Clinical Trial Lead you are responsible for oversight of the team of field Clinical Research Associates (CRA) or In-House CRAs who provide qualification, selection, monitoring, and close out of sites performing clinical trial(s).  Lead Clinical Research Associates/Clinical Trial Managers review workload requirements and provide resourcing for all clinical in-house and field activities.  You will ensure that staff perform their duties in line with all country governing agency regulations and the International Conference of Harmonization- Good Clinical Practice (ICH-GCP).  You work closely with study Project Management to ensure clinical delivery and execution in line with project contracts.

Position Accountabilities/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.).  In the event of CRA performance concerns, evaluate cause and mitigate risk to the study. Escalate CRA performance issues to Clinical Monitoring Management as needed.
• 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.