Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We're looking for an exceptional Clinical Research Associate II / Senior CRA to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. At Premier Research, we are science-minded and heart-centered. Join us.
You'll be doing: Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.Maintains submission of expenses according to travel and expense requirements within company guidelines.Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements.Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.Plans day to day activities for monitoring of a clinical study and sets priorities per site.Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum.Monitors with knowledge of quality/scope/timeline and budget parameters.Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase.Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member.Manages query resolution process with sites and Premier Research Data Management.Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization's processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates.Assists project team with assessing project feasibility and recruitment, as applicable.Participates in Investigators' Meeting as designated by the Project Manager.Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.Attends meetings as required.Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager.Completes timely entry of hours worked and project codes per time entry guidelines.Acquires basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge.Maintains proper, timely communication with study teams and management, as needed.Completes all required internal training (general and study-specific) on-time.Identifies confidential information and complies with global and local laws and guidelines.In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description.In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead.Acts as a resource/mentor for other CRAs and shares knowledge base and best practices.You'll need: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required.Previous clinical research experience required, completion of CRA training program.Read, write and speak fluent English; fluent in host country language.Successful previous experience.Experience in coaching/mentoring other CRAs.Global experience preferred.At least 4 years' experience in clinical trials.Experience in monitoring complex trials or global trials or equivalent experience.Knowledge of ICH / GCP regulations.Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device regulations.
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