Senior Clinical Research Associate

Company: Parexel
Location: San Jose
Posted on: January 24, 2023

Job Description:

Position Purpose: The Senior Field Clinical Research Associate (fSrCRA) 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.
Organizational Relationships: - Reports to Line Manager with day-to-day direction from the Client. - Liaises with cross functional lines as appropriate.
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 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 GCP. - Perform Interim Monitoring Visits for assigned studies: - Monitor site compliance with study protocol, and GCP. - Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. - Ensure the site is entering data according to the Case Report Forms (CRF) Completion Guidelines and meeting data entry and query resolution deadlines. - Perform drug accountability and ensure adequate drug supply. - Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required. Assist study team as necessary in resolving lab queries and other issues. - Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. - Ensure adequacy of clinical supplies to the site. - Collect and review site essential documents and ensure site regulatory file is complete and accurate. - Monitor site compliance with IRB policies/processes and ensure timely submissions and approvals.

- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. - Ensure site staff is appropriately trained, and site responsibilities are delegated to qualified staff. - Perform Close Out visits as assigned. - Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. - Track, report, and follow all action items to resolution. - Maintain Clinical Trial Management (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/site per CMP. - Assist data management as required. - Provide co-monitoring support as requested. - Contribute to the preparation and follow-up of on-site sponsored quality audits and regulatory authority inspections as assigned. - Complete routine administrative tasks in a timely manner. - Discuss scientific, medical and therapeutic area information. - Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides). - 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 Clinical Monitoring Plans and CRF Completion Guidelines and other study documents. - May serve as a Subject Matter Expert (SME). - Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training - Adheres to EP and Client SOPs and processes
Skills and Education: - BA/BS, or equivalent, or relevant experience and training with at least 3 years of pharmaceutical/biotech experience. RN or health care professional preferred. - Prior monitoring experience is required. Oncology/hematology clinical trial experience is preferred. FDA/EMA inspection experience is preferred. - Proficiency in CFR and GCP/ICH 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). - Excellent communication and organizational skills.

Keywords: Parexel, San Jose , Senior Clinical Research Associate, Other , San Jose, California