Senior/Clinical Research Associate at Precision… · Remote

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate.

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• 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.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the 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.
• 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, as required/appropriate. 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. Prepares and submits for review, 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 to track all observations, ongoing status and assigned action items to resolution.
• 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 the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures 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. Also 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 the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience；
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

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