Catalyst Clinical Research ยท 22 hours ago
Clinical Trial Lead
United States
Full-time
Remote
Senior Level
5+ years expCatalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries. As the Clinical Trial Lead, you will oversee a team of Clinical Research Associates and ensure compliance with regulations while managing clinical trial activities.
Pharmaceutical
No H1B
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
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
Qualification
Required
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 supporting oncology studies
Indication specific experience as dictated by the study protocol or as specified by client requirements
GCP certification
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, 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
Company
Catalyst Clinical Research
Catalyst Clinical Research is a provider of clinical operation solutions to the biotechnology, pharmaceutical and medical device companies.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2018-10-31Acquired
Leadership Team
Niklas Morton
Chief Executive Officer
Recent News
2025-10-31
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