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Clinical Trials Monitor
2 months ago
Overview:
As a Clinical Trials Monitor at Pharmaceutical Research Associates, Inc., you will become part of a leading global clinical research organization, driven by healthcare insights.
Key Responsibilities:
Your Role:
Conducts both onsite and remote monitoring tasks in alignment with all ICH-GCP standards, relevant regulations, SOPs, and study protocols.
This includes evaluating potential investigative sites, initiating clinical studies, maintaining study documentation, and providing guidance to site personnel during study closure.
Ensures the safeguarding of study participants by verifying that informed consent processes and protocols are executed in compliance with applicable regulations.
Guarantees the accuracy of clinical data and that the study is executed in accordance with the approved protocol, GCP, relevant regulations, and SOPs.
Confirms the proper management and accountability of Investigational Product (IP).
Drafts and submits reports on investigative site observations and updates relevant tracking systems. Raises any identified deficiencies, issues, and corrective action plans as necessary.
Manages essential documentation as mandated by local regulations and ICH-GCP standards before, during, and after a clinical study; assists in resolving investigational site/data inquiries.
Conducts key risk assessment and management duties throughout the project, including key risk indicators and site health evaluations, site process assessments, and project escalations.
Independently performs various onsite and offsite monitoring visit types.
Collects and reviews information for assigned sites and identifies discrepancies. With limited guidance from project and functional management, evaluates risk and escalates as needed.
Assists with non-complex ad hoc, short-term tasks in support of additional studies or departmental initiatives.
May act as a mentor, providing training to less experienced clinical team members.
Qualifications:
We Seek:
A minimum of 2 years of experience in supporting clinical trials, including 2 years of onsite monitoring experience.
Comprehensive knowledge of the drug development process.
Thorough understanding and practical application of ICH-GCP and relevant regulatory requirements.
Solid knowledge of applicable policies, procedures, SOPs, work instructions, and other guidance documents.
Effective spoken and written communication skills; strong presentation abilities.
Excellent interpersonal, collaboration, and time management skills.
High proficiency in Microsoft Office and company collaboration tools.
Exceptional skills in utilizing relevant clinical systems.
Strong critical thinking and organizational skills.
Ability to maintain focus on details for extended periods; high attention to accuracy.
Willingness to travel extensively.
Capability to establish and maintain effective working relationships with investigative site personnel.
A bachelor's degree or international equivalent in a clinical, scientific, or health-related field from an accredited institution; healthcare professional licensure, such as registered nurse. A combination of education, training, and relevant experience may be considered in lieu of the stated education and experience.
What We Offer:
Our success is rooted in the quality of our workforce. We prioritize building a diverse culture that recognizes high performance and nurtures talent.
In addition to a competitive salary, we provide a range of supplementary benefits.
Our benefits are tailored to be competitive within each country and focus on well-being and work-life balance opportunities for you and your family.
Examples of Our Benefits Include:
Various annual leave entitlements.
A selection of health insurance options to meet you and your family's needs.
Competitive retirement planning options to maximize savings and plan confidently for the future.
Global Employee Assistance Program, offering 24-hour access to a vast network of specialized professionals dedicated to supporting your and your family's well-being.
Life insurance.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers website to learn more about the benefits of working with us.
Company Culture:
At Pharmaceutical Research Associates, Inc., diversity, inclusion, and belonging are integral to our culture and values. Our rich diversity fosters innovation, enabling us to better serve our people, patients, customers, and communities. We take pride in our diverse workforce and our commitment to creating a more inclusive organization. We are dedicated to providing an inclusive and accessible environment for all candidates. We are committed to maintaining a workplace free from discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you require reasonable accommodation due to a medical condition or disability for any part of the application process or to perform the essential functions of a position, please inform us through the appropriate channels.
Interested in the role but unsure if you meet all the qualifications? We encourage you to apply regardless – you may be exactly what we are looking for at Pharmaceutical Research Associates, Inc., whether for this position or others.
