Research Analyst

• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
• Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
• Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
• Customize site engagement strategy for assigned study (ies) under supervision.
• Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Clinical Research Associate I

• Drive study performance at the sites.
• Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.
• Provide the required monitoring visit reports within required timelines.
• Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
• Contribute to the selection of potential sites and investigators.
• Train, support and advise Investigators and site staff in study related matters.
• Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations.
• Manage study supplies, drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Ensure data query resolution.
• Work with data management to ensure quality of the study data.
• Ensure accurate and timely reporting of Serious Adverse Events.
• Share relevant information on patient recruitment and study site progress within local Study Team.
• Update VCV and other systems with data from centers as per required timelines.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.

Clinical Research Associate II – CART

• Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol
• Build relationships with investigators and site staff
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis
• Conduct on-site visits for Qualification and Initiation visits
• Generate visit/contact report
• Evaluate overall compliance and performance of sites and site staff
• Ensure that assigned sites are audit and inspection ready
• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships

Senior Clinical Research Associate

• 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.

• Drive study performance at the sites
• Perform site monitoring and other onsite visit activities
• Provide the required monitoring visit reports within required timelines
• Proactively identify study-related issues and escalates to Local Study Teams
• Train, support and advise Investigators and site staff in study related matters

Clinical Research Associate II – FSP

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
• Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

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