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(CTL), you will be responsible for overseeing a team of
Clinical Research Associates (CRA) who provide qualification, selection, monitoring, and close out of
sites performing clinical trial(s) as well as monitor’s sites. You will review work load requirements
and provide resourcing for all clinical field activities. Additionally, you will insure that staff perform
their duties in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration
(FDA) and the International Conference of Harmonisation[1]Good Clinical Practice (ICH-GCP).
Position Accountabilities/Responsibilities:
- Oversee the conduct of monitoring/co-monitoring activities for site initiation visits, interim
guidelines, protocol, and internal SOPs/policies.
- Ensure the monitors are adequately trained on the therapeutic area and study and are
- Identifies site findings with the ability to re-train, place corrective action in place with the
- Develop and monitor metrics to evaluate the monitor and site performance (trip report
and mitigate risk to the study.
- Review and approve monitoring visit reports.
- Co-monitor as required to provide coaching and manage performance of CRAs.
- Prepare study documents such as the monitoring plan, annotated trip reports templates,
manual, pharmacovigilance plan and informed consents.
- Implements processes for distribution and tracking of SAEs, safety documentation, and
- Help with the planning and participation of Investigator Meetings.
- Reviews/creates/tracks trial newsletters, memos, mass correspondence or other
- Assists in evaluation of vendor performance during conduct of the study.
- Maintains clinical trial tracking information pertaining to the study
- Assists with auditing of study files and retrieval of outstanding documents as needed (inhouse and on-site document reconciliation); assists with maintenance of Trial Master File as
- Develops and maintains collaborative relationships to manage study issues and support
manner escalates issues to study management as needed; troubleshoots and follows up on
study progress; and reviews report data for completeness and accuracy.
- Assists with audit/inspection responses.
- Prepares key reports and documents on progress of study for client or internal project
Position Qualifications and 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, comonitoring, accompanied site visits). A minimum of 2-3 years Lead CRA/CTL experience. Indication
specific experience as dictated by the study protocol or as specified by client requirements.
Required Certifications: GCP
Required Skills:
- Good knowledge of medical terminology, protocol, clinical trial process, regulatory
- Good knowledge of therapeutic area assigned.
- Strong knowledge of FDA regulations and ICH GCP guidelines
- Excellent verbal and written communication skills; excellent interpersonal and organizational
- Familiarity with EDC and CTMS systems; ability to learn required systems quickly and to train
- 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/
- 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
- Ability to present at internal study team meeting(s).
- Ability and willingness to travel up to 30%.
- Take part in hiring and training monitors (CRAs)
- Ensure the monitors are adequately trained on the therapeutic area and study and are
- Review and approve CRAs time within time management system. Monitor compliance with
- Take part in performance review for the CRA
based.
Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are
committed to creating an inclusive environment for all employees.
