Senior CRA at Precision Medicine Group - Remote Brazil — Columbus

We're expanding our capabilities across Latin America, and we're hiring a Senior Clinical Research Associate to support critical studies across Brazil!

As a Senior CRA you'll possess a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start-up procedures including feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation of Patient Informed Consents, notifications to IRB, EC and regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of archiving requirements for essential documents
• Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions
• Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies IP has been dispensed and administered to subjects/patients according to the protocol. Applies knowledge of GCP/local regulations to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of risks with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings and attends clinical training sessions according to project specific requirements
• Assists team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and development of new employees and junior monitors
• Interacts with clients, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned

Minimum Education & Experience:

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing in English at a professional level

Preferred Education & Experience:

• Graduate or postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolve project-related problems and prioritize workload to meet deadlines. Can assist junior CRAs in problem resolution
• Ability to travel overnight; up to 60% travel on average based on regional requirements. International travel as needed
• Select opportunities require Oncology experience, preferably in early phases
• Self-motivated and able to work and plan independently as well as in a team environment
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, you may contact Precision Medicine Group at [email protected].

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.