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Clinical Research Associate - Oncology Academy (FSP)

Parexel International Corporation

France - Any Region - Home Based

If you are an experienced CRA looking to move into oncology trials this might be an interesting opportunity.

Parexel FSP are recruiting for experienced CRA's to be sponsor dedicated to one of our Oncology sponsors, in this role you'll also join the Parexel Oncology Academy.

This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.

Organizational Relationships:

Reports to FSP assigned 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 Perform Close Out visits as assigned. Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. 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. Provide co-monitoring support as requested. Contribute to the preparation and follow-up of on-site Seattle Genetics sponsored quality audits and regulatory authority inspections as assigned. Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides). 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. QualificationsSkills and Experience:BA/BS, or equivalent, or relevant experience and training with at least 2 years independent monitoring experience. Willingness to learn and develop within the oncology therapy area. 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.

#INFSP

Job posted: 2022-02-20

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