[Hiring] Senior Clinical Research Associate @Precision Medicine Group

Role Description

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

• Independently overseeing all aspects of study site management to ensure patient safety is protected and quality of data generated by managed sites results in consistently low query levels and acceptable Quality Assurance reports.
• Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audit and required follow-up actions.
• Establishing, updating, tracking, and maintaining study specific trial management tools/systems, and status reports.
• Managing 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 in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• Assisting with the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee, if required.
• Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Independently conducting 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.
• Documenting 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.
• Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Communicating effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management.
• Developing and maintaining good working relationships with investigators and study staff.
• Performing investigational product (IP) inventory, reconciliation, and reviews storage and security.
• Identifying and processing Serious Adverse Events according to the procedures defined by the study team.
• Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings.
• Assisting the team managers in the preparation and review of protocols and other study documentation.
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors.
• Interacting with clients, participating in proposal activities, including development and client presentations.
• Initiating payment requests for investigators.
• Traveling as necessary according to project needs.
• Other job duties as assigned.

Qualifications

• 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 proficiently (Professional level).

Requirements

• Graduate, postgraduate degree preferred.
• 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 with oversight from management.
• Ability to travel overnight, up to 60% travel on average, based on regional requirements.
• Select opportunities require Oncology experience, preferably in early phases.
• Exhibits self-motivation and is 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.
• Demonstrated focus on continuous improvement.

Company Description

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 or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

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