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 a Clinical Trial Lead you will be a member of the core project team. You will be responsible for oversight of the team of field Clinical Research Associates (CRA) and/or In-House CRAs who provide evaluation, initiation, monitoring, and close out of sites performing clinical trial(s). You will review workload requirements and provide resourcing for all clinical in-house and field activities. They 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). They work closely with study Project Management to ensure clinical delivery and execution in line with project contracts and serve as a point of contact for client staff.

Position Responsibilities/Accountabilities:

• Participate in the feasibility process, assisting with site selection and overseeing site evaluation activity.
• Prepare study documents such as annotated visit reports and visit report templates, Clinical Monitoring Plan, Cohort
• Management Plan, study specific templates, SIV training presentation, study operations manual, source data verification plan, laboratory manual and informed consents.
• Review and provide input to study functional area plans (i.e., Data Review Plan, (electronic)TMF Specifications Plan, Site
• Start Up Plan, etc.)
• Help with the planning and participate in Investigator Meetings.
• Oversee the conduct of monitoring/co-monitoring activities for site initiation, interim site monitoring, and closeout, including visit forecasting, in compliance with all governing laws, regulations, guidelines, protocol, and internal
• SOPs/policies.
• Ensure the monitors are adequately trained in 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.
• Assist in driving patient recruitment at sites and participates, in conjunction with site assigned CRAs, in the development
• of enrollment plans.
• Identify site findings with the ability to re-train, develop corrective action 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 (visit report tracking, days on site needed, query and action item completion/resolution, etc.). In the event of 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.
• Liaise with data management to identify trends in data entry and review.
• Lead regular project level CRA meetings and document 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 visit reports and visit report templates, Clinical Monitoring Plan, Cohort
• Management 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. Monitor compliance of these processes.
• Review/create/track trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
• Assist in evaluation of vendor performance during conduct of the study.
• Maintain clinical monitoring activity tracking information pertaining to the study. Serve as the point of contact for clients related to clinical monitoring activity.
• Assist with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation); assist 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; troubleshoot and follow up on study progress; and review report data for completeness and accuracy.
• Participate in project audits, as necessary, and assist with audit/inspection responses.
• Prepare key reports and documents on the progress of study for client or internal Project Manager as appropriate.
• Assist with identification of out-of-scope activities and escalate to the Project Manager as appropriate.
• Participate in business development activity including attending and presenting at bid defense meetings.

Managerial Requirements/Responsibilities: N/A

Position Qualifications/Requirements:

Education: 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.

Experience: A minimum of 5-7 years of field monitoring experience (e.g., independent monitoring, co-monitoring,). A minimum of 1-2 years Lead CRA/Clinical Trial Lead experience or other relevant experience.

Required Certifications: GCP

Required Skills:

• 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 learn required systems quickly and to train others, especially site staff. ·
• Ability to meet deadlines, multitask, 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 and lead 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.