Lead Clinical Research Associate

Protrials; Deutschland; Hybrid; EUR 52.000 - 75.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

Flexible PTO

401(k) with company match

Zusammenfassung

ProTrials is a women-owned, WBENC-certified CRO seeking an experienced Clinical Research Associate Oversight role. You will liaison between CRAs, internal staff, site personnel, clients, and vendors to ensure study success.

You will ensure monitoring activities align with SOPs, GCP, regulations, and project KPIs, while developing plans, managing timelines, and supervising TMF/eTMF processes.

Qualifikationen

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training.
• Previous CRA experience preferred.
• Excellent communication, organization, prioritization, presentation, discretion, and accuracy.
• Solutions-oriented approach to problem solving.
• Familiarity with medical and pharmaceutical industry and terminology.
• Extensive knowledge of FDA regulations and their practical implementation.
• Willingness to travel and perform remote and on-site monitoring, if needed.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Aufgaben

• Provide study oversight as the primary liaison between CRAs, internal staff, site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study.
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with SOPs, regulations, good clinical practices, KPIs, 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; review data reports and CTMS; disseminate listings to study CRAs; work with 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 CROs regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters per SOP requirements.
• Manage oversight of the TMF/eTMF and assist with filing and quality control.
• Track SAEs, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with the study team.
• Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed.

Kenntnisse

Communication

Organization

Prioritization

Presentation

Discretion

Accuracy

Problem solving

Solutions-oriented

Travel readiness

MS Office proficiency

Ausbildung

RN

Bachelor's degree in biological sciences or related field

Advanced degree in biological sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we've supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.

Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you'll join a collaborative community committed to making a meaningful impact on global health.

We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.

ABOUT THE JOB

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study
• 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 needed
• 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 PowerPoint

• 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.

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 [e-mail].

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.