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Sr. Clinical Research Associates (Can live anywhere)

Company: InfraStaff
Location: Oakland
Posted on: May 17, 2018

Job Description:

Looking for Med Techs/RNs/PAs who has worked in ICU, Cardiac Unit (ideally). This is in addition to having CRA/field monitoring experience. Sr. Clinical Research Associate monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs. Essential Functions: Thorough knowledge and application of project specific protocol Consistently completes on site monitoring in accordance with project specific timelines Consistently completes travel scheduling in accordance with project specific and UBC guidelines Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections Ensures follow-up of site issues and action items per UBC/sponsor timelines Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol Monitors within EDC data entry, if applicable, and assists sites with DCF resolution Completes Regulatory Binder and Investigational Product reconciliation Maintains regular contact with assigned sites per study requirements Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines Consistently completes SOP review and documentation within requested timelines Consistently completes sponsor specific training and documentation within requested timelines Assists PM and management team by being an AIM leader A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individuals ability to perform visit type independently I = Instruct how to conduct visit, report/letter writing and manage issues and actions M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit Assists management team by mentoring other CRAs Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training Qualifications: Bachelors degree " Life Science preferred or equivalent years of industry and monitoring experience Must have experience with at least 1 of the following therapeutic areas: Cardiovascular/ heart failure/heart disease AND/OR Oncology Minimum of > 24 months activesitemonitoring Thorough knowledge of medical terminology Good written and verbal communication skills Consistently meets or exceeds metrics for quality trip reports and letters Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable) Thorough knowledge of ICH, GCP, CFR and UBC SOPs Up to 80% - 90% travel

Keywords: InfraStaff, Oakland, Sr. Clinical Research Associates (Can live anywhere), Healthcare, Oakland, California

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