Lead Clinical Research Associate - Pipelining for Future Jobs | L392
Protrials Research
- Mar del Plata, Provincia de Buenos Aires
- 135.000-159.000 $ pesos al año
- Permanente
- Tiempo completo
- Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements
- Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies
- Create annotated visit report templates and other documents and strategies related to site management and monitoring
- Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented
- Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
- Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control
- Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team
- Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as neededHERE IS WHAT YOU BRING TO THE TABLE:- RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
- Previous CRA experience preferred
- Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy
- Solutions-oriented approach to problem solving
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Extensive knowledge of Food and Drug Administration regulations and their practical implementation
- Willingness to travel and perform remote and on-site monitoring, if needed
- Proficiency in Microsoft Word, Excel, and PowerPointHERE IS WHAT WE OFFER:- Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.
- We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.
- You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals.
- At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.
- We have the best coworkers, if we do say so ourselves.$135,000 - $159,000 a yearOur salary ranges are determined by various factors. The actual base compensation for this position may vary depending on experience, market conditions, education/training, skill level, and location.Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact .ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.#J-18808-Ljbffr
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