[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 leader in Clinical Trial Services, and they are seeking a Clinical Research Associate II to reputed company study site management and ensure patient safety. The role involves monitoring clinical research studies, site management, and ensuring compliance with regulatory standards.

Responsibilities

Oversees reputed company aspects of study site management to ensure patient safety is protected, reputed company of data generated by managed sites resulting in consistently low query reputed company and in acceptable reputed company 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 reputed company 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 reputed company, including reputed company-study/ qualification, initiation, routine monitoring, and reputed company-out reputed company, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and reputed company monitoring reports from reputed company site reputed company (on-site and remote) Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and reputed company requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company 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 reputed company and reputed company image Performs investigational product (IP) inventory, reconciliation and reviews storage and reputed company Verifies the IP has been reputed company 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 reputed company review, query reputed company, and assists data management and clinical data reputed company 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 reputed company and appropriate reputed company 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. reputed company player Experience monitoring oncology trials Evidence of a reputed company reputed company 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 Disability benefits Parental leave reputed company time off for reputed company leave and vacation reputed company We founded reputed company in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It was founded in 2012, and is headquartered in Bethesda, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https//www.precisionmedicinegrp.com/pfm/. Apply tot his job Apply To this Job