Central Monitor
1 month ago
Responsibilities:
- Participate in the development of the risk assessment module of a Risk-Based Quality Monitoring (RBQM) tool at a study level.
- Lead the development of the central monitoring module of a Risk-Based Quality Monitoring (RBQM) tool at a study level.
- Support project functional leaders to identify study specific Critical To Quality Factors (Critical Processes and Critical Data)
- Collaborate cross-functionally to identify risk and define risk mitigation strategies.
- Define Key Risk Indicators within the RBQM system.
- Perform central monitoring analysis to identify areas of concern and trends. Collaborate with Clinical Research Associates where mitigation is required.
- Effectively communicate with site study staff and Catalyst Clinical Research, LLC. clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues.
- Support RBQM project team and coach internal Catalyst staff in RBQM processes and tools.
Education: University/college degree in life sciences preferred (or the equivalent of 4-5 years industry experience, or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology, or equivalent, relevant experience).
Experience:
- Minimum of 3 years direct site monitoring experience with a sponsor company or CRO
- Minimum of 1.5-2 years prior experience as a central monitor working in a RBQM platform (i.e., TRI OPRA, Cluepoints, Power BI, etc.)
- Prior experience setting up the RBQM central monitoring module, preferred
Required Skills:
- Strong knowledge of FDA, MHRA or EMA regulations, as appropriate, and ICH GCP guidelines.
- Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
- Good knowledge of assigned therapeutic area.
- Proficient with Microsoft Office Suite.
- Familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to work independently and as a member of various teams and committees.
- Good judgement with the ability to make timely and sound decisions.
- Ability and willingness to travel up to 10%, as needed.
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