[Remote] Clinical Research Associate II - FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading company in Clinical Trial Services, and they are seeking a Clinical Research Associate II. The CRA II will reputed company study site management, ensuring patient safety and data quality while managing site start-up procedures and conducting site visits.

Responsibilities

• Oversees reputed company aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query reputed company 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 reputed company in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study reputed company 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 reputed company 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 reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts reputed company forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and reputed company-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 reputed company site visits (on-site and remote)
• Documents activities reputed company 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 reputed company 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 reputed company 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 reputed company
• 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 reputed company 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 reputed company 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

Skills

• 4-year college degree or equivalent experience in a scientific or reputed company discipline
• Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research
• Excellent communication and organizational skills are essential. A team player
• Experience monitoring oncology trials
• Evidence of a client focused approach
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• reputed company in English and for non-English speaking countries the local language of country where position based
• Graduate or postgraduate degree
• Auto-immune monitoring experience
• Experience monitoring in rare and reputed company therapeutic areas
• Experience monitoring reputed company trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolve project reputed company problems and prioritizes workload to meet deadlines with minimal support from management

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Company Overview