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Join to apply for the Associate Clinical Research III role at Katalyst CRO

Join to apply for the Associate Clinical Research III role at Katalyst CRO

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• The Associate Clinical Research III will assist in the clinical execution and management of all aspects of assigned clinical studies.
• This includes but is not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
• The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
• Responsible for the design, execution and monitoring of internal clinical studies.
• Participate in the design, training and monitoring of Client sponsored external clinical studies including PMA and outcome studies.
• Participates in identification and qualification of external clinical sites.
• Participate in the development and maintaining of standard operating procedures.
• Participate in cross functional team activities for product development.
• Effectively communicates the outcomes of the study to cross functional teams.
• Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance with the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
• Participate in study start up activities.
• Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
• Maintain and audit Trial Master File to ensure inspection readiness.
• Perform a review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager as needed.
• Proactively and effectively communicate the status of clinical studies to management.
• May interact with RA/QA in responding to audits and FDA inquiries.
  
  

• The Associate Clinical Research III will assist in the clinical execution and management of all aspects of assigned clinical studies.
• This includes but is not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
• The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
• Responsible for the design, execution and monitoring of internal clinical studies.
• Participate in the design, training and monitoring of Client sponsored external clinical studies including PMA and outcome studies.
• Participates in identification and qualification of external clinical sites.
• Participate in the development and maintaining of standard operating procedures.
• Participate in cross functional team activities for product development.
• Effectively communicates the outcomes of the study to cross functional teams.
• Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance with the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
• Participate in study start up activities.
• Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
• Maintain and audit Trial Master File to ensure inspection readiness.
• Perform a review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager as needed.
• Proactively and effectively communicate the status of clinical studies to management.
• May interact with RA/QA in responding to audits and FDA inquiries.
  
  

• BS degree in life sciences with six years of experience as a CRA or CRC or combination of appropriate education and experiences required.
• Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations.
• Experience in conducting medical device and/or in-vitro diagnostics studies.
• Pharmaceutical background may also be considered.
• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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