ProTrials Research Inc.

Research Analyst

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements
• Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies
• Create annotated visit report templates and other documents and strategies related to site management and monitoring
• Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented
• Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
• Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control
• Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team
• Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed

Lead Clinical Research Associate

QA Engineer

• Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution, including proper and timely documentation
• Facilitates and conducts internal and external audits and provides metrics and analysisof trends based on audit findings
• Assist in the conduct or arrangement of GCP training for all staff
• Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems
• Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers
• Responsible for providing quality oversight to the revision, review, and approval of controlled documents
• Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner
• Responsible for providing input and support as appropriate to the creation of new controlled documents
• Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions
• Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training
• Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required
• Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations
• Assist QA management with the evaluation of learning management systems and other QA technology, as required
• Assist in the preparation of quality metrics and reports
• Assist QA management team with other Clinical QA activities as required
• Other duties, as assigned

Lead Clinical Research Associate

Quality Assurance Specialist