Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide support and services exclusively to biotech companies because we know and understand the biotech environment. Our 15+ years of experience allow us to quickly grasp the evolving needs of our clients so we can deliver the solutions essential to meet the evolving needs and unexpected changes inherent in oncology development. When protocols amend or emerging data suggest a breakthrough straight from Phase I to registration, we are ready.

　　Position Summary:

　　The Central Monitor is a key member of the Development Operations Clinical Monitoring Team.  The Central Monitor is responsible for review and analysis of data within the designated Risk-Based Quality Monitoring (RBQM) tool in a manner consistent with relevant global regulations as well as Catalyst Clinical Research, LLC.’s applicable SOPs and working practices .  The Central Monitor will work closely with the project team to identify study level risks and collaborate cross-functionally to define risk mitigation strategies. 

　　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.

　　Qualifications:

　　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.

　　This role can be 100% remote or office based. 

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