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Senior Clinical Research Associate

Company: Galvanize Therapeutics, Inc.
Location: Pomona
Posted on: August 7, 2022

Job Description:

Job Description Salary: Exempt; DOE The Senior CRA position is a fully qualified role in clinical affairs requiring extensive experience in the conduct of clinical trials. The Senior CRA works with all members of Clinical Affairs, Regulatory Affairs, Quality Assurance and Research and Development. This role also works with personnel at clinical investigational sites on routine and complex matters to accomplish proper study execution during all phases of clinical trials. The position requires significant business travel. The Senior CRA works under the general guidance of a Manager or Clinical Study Manager. A person in this position may determine his/her own objectives, independently plan work and develop solutions to challenges in clinical affairs. The Senior CRA has the experience to interact competently with investigational sites and to handle complex assignments. Performance is evaluated on a periodic basis for soundness of judgement and accuracy. Key Responsibilities: Clinical Operations Leads a variety of assignments related to study site management and other clinical projects and systems Identifies and leads process improvement projects Contributes significantly to the development of study materials and review of eCRFs, EDC systems and source worksheet creation Contributes to the development of clinical documents such as clinical protocols, consent forms, clinical monitoring plans, clinical study reports, annual regulatory reports, and clinical reports/forms/SOPs/Work Instructions. Performs co-monitoring visits as needed to ensure consistency and quality standards of monitoring activities are being met with other contract and/or sponsor monitoring team members Collaborates with other clinical staff and departments to ensure the clinical studies are conducted in compliance with Federal, State, and local regulations, Good Clinical Practices and internal Standard Operating Procedures Helps to define and develop clinical operations and programs efficiently, cost effectively and with high-quality execution Responsible for Interim Monitoring Visit Report review to ensure consistency of monitoring and adherence to company SOPs across all sites per study Provides study status update reports to the internal study team, study sites, and external vendors. Tracks and provides updates to study management on potential trends noted across multiple sites and discusses potential strategies to remedy any potential issues Escalates observed deficiencies and issues to clinical study management and follows issues through to resolution Mentors, trains, co-monitors and contributes to the growth/development of junior clinical team members Clinical Monitoring Responsible for making recommendations for site identification and selection activities Manages site initiation, monitoring and close-out activities for assigned investigational sites ensuring adherence to applicable regulations, principles of ICH-GCP and SOPs Manages assigned site activities through all phases of the clinical trial including site qualification, site initiation, subject enrollment and follow-up, and site close-out at assigned sites. Facilitates and tracks site IRB/EC submission, approval, annual review, and closure process at assigned sites Facilitates the negotiation of clinical trial agreements and budgets Conducts protocol training for investigators, study coordinators and other site personnel. Ensures proper documentation of site personnel training and delegation of Establishes and maintains regular contact with investigational site personnel to ensure ongoing protocol compliance, resolution of action items and queries, and accurate and timely data entry Identifies, documents, and communicates quality and/or compliance related issues in a timely manner to a senior team member Ensures that study documentation is up to date and audit ready at sites and within the study trial master file (TMF) through periodic TMF QC checks. Coordinates, schedules, and conducts monitoring visits at investigational sites to ensure compliance to the clinical protocol, Federal, State, and local regulations, the principles of ICH/GCP and internal standard operating procedures Responsible for tracking and reconciliation of investigational product inventory at assigned sites and study-wide; follows-up with investigational sites Professionally represents the company Develops and maintains cross functional and collaborative relationships within the company and at investigational sites Assists clinical study manager with other duties as needed Key Requirements Education and Training Bachelor---s degree in life sciences, medicine, or technical discipline preferred. Advanced degree (MD, PhD, MS, DVM) and 1-2 years clinical research experience, or BS and minimum 3 years clinical trial experience, or 5 years clinical trial experience, or Completion of a certification program in clinical trial conduct and 3-5 years clinically focused industry experience. Pulmonology experience preferred. Exceptional experience/background in a particular scientific area that meets a specific business need but with less clinical trial experience. Skills and Experience Medical device research experience preferred. Exposure to or experience with clinical monitoring activities Superior knowledge of US and international clinical regulations and guidelines Proficient in Microsoft Office with technical abilities to become proficient quickly with numerous other electronic systems. Detailed oriented, with solid organization and time management skills. Able to work independently and in a team environment. Complete projects with reliability and minimal guidance Good communication skills with the ability to interact with site personnel to ensure compliance. Travel: Ability to travel up to 70%, domestically and internationally. Overnight travel is required. Position Reports To: Clinical Study Manager

Keywords: Galvanize Therapeutics, Inc., Pomona , Senior Clinical Research Associate, Healthcare , Pomona, California

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