[Remote] Clinical Research Associate II - FSP

Note: The job is a remote job and is open to candidates in USA. Precision Medicine Group is a leader in Clinical Trial Services, and they are seeking a Clinical Research Associate II to oversee study site management and ensure patient safety. The role involves monitoring clinical research studies, site management, and ensuring compliance with regulatory standards.ResponsibilitiesOversees 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 reportsProvides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actionsUpdates, tracks and maintains study specific trial management tools/systems, and status reportsIf 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 ManagerIf required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designeeVerifies 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 issuesIndependently 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 resolutionRoutinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completenessReconciles 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 regulationsCommunicates 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 issuesDevelops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional imagePerforms investigational product (IP) inventory, reconciliation and reviews storage and securityVerifies the IP has been dispensed and administered to subjects/patients according to the protocolVerifies 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/returnedPerforms 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 discrepanciesIdentifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting processIdentifies 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 teamPrepares 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 requirementsTravels as necessary according to project needsPerforms other duties as assigned by managementSkills4-year college degree or equivalent experience in a scientific or healthcare disciplineTwo (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 researchExcellent communication and organizational skills are essential. A team playerExperience monitoring oncology trialsEvidence of a client focused approachExperience using computerized information systems, electronic spreadsheets, word processing and electronic mailAbility to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as neededFluency in English and for non-English speaking countries the local language of country where position basedGraduate or postgraduate degreeAuto-immune monitoring experienceExperience monitoring in rare and complex therapeutic areasExperience monitoring EDC trials and EHR recordsExperience in biopharma or relevant therapeutic areaRelevant site start-up (feasibility, contract negotiations, submissions) experience for the particular countryAbility to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelinesAbility to resolve project related problems and prioritizes workload to meet deadlines with minimal support from managementBenefitsDiscretionary annual bonusHealth insuranceRetirement savings benefitsLife insuranceDisability benefitsParental leavePaid time off for sick leave and vacationCompany OverviewWe founded Precision Medicine Group 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/.