Senior Field CRA (Northeast) - FSP

Parexel International Corporation

United States of America, Remote

Position Purpose:

The Senior Clinical Research Associate is responsible for field monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.

Primary Duties: Act as liaison between the in-house team, vendors, and multiple clinical sites.Work collaboratively with investigative sites to develop strong, long-term, working relationships.Apply Standard Operating Procedures (SOPs), Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.Help identify and qualify potential investigators. Perform Pre-Study Site Visits.Assist with start-up activities, including essential document review and collection as requested.Perform Site Initiation Visits.Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and Good Clinical Practices (GCP).Perform Interim Monitoring Visits for assigned studiesPerform Close Out visits as assigned.Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CPM.Track, report, and follow all action items to resolution.Maintain Clinical Trial Management System (CTMS) in a timely fashion, utilizing available reports and study tools.Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to Client per CMP.Assist data management as required.Provide co-monitoring support as requested.Contribute to the preparation and follow-up of on-site Client sponsored quality audits and regulatory authority inspections as assigned.Complete routine administrative tasks in a timely manner.Discuss scientific, medical and therapeutic area information.Attend staff meetings and trainings as required.May have opportunities to contribute to other clinical trial related activities, including vendor management, data review, or other study-related activities.Contribute to department initiatives.May contribute to development and revision of study specific CMPs and CRF Completion Guidelines and other study documents.May serve as a Subject Matter Expert (SME).Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides).Lead and drive, with support and oversight from the Client team / regulatory vendor, Ethics Committee submission requirements and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team. Additional responsibilities will include essential document collection, tracking, review and provision of country/site requirements to support the achievement of site activation goals and on-going maintenance activities in compliance with GCPs and applicable local and international regulations and Client SOPs.Support clinical trial management tasks delegated from the internal Client management team to support local start up requirements for implementation of the trial.Submit annual safety reports and updates to Ethics Committee per local requirements and process.Completes training assigned by Client and/or Parexel FSP, as necessary, including general training requirements, SOPs, and system and process related trainingAdheres to Parexel FSP and Client SOPs and processes

Skills and Education: BA/BS, or equivalent, or relevant experience and training with at least 6 years of pharmaceutical/biotech experience.RN or health care professional preferred.Prior monitoring experience is required.FDA/EMA inspection experience is preferred.Proficiency in CFR and ICH/GCP Guidelines is required. Experience working on global clinical trials is preferred.Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).Flexibility towards work assignments, learning, and travel.Able and willing to travel approximately 55-75%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location. Highly responsive and proactive, a team player.


2022-09-19 00:05:13

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