Senior Clinical Research Associate (level dependent on experience) in United States Embassy at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate (level dependent on experience) based in United States.

This role offers the opportunity to contribute to the advancement of clinical research by managing monitoring activities across Phase I–IV clinical trials and Real World Evidence studies.
The position plays a key role in ensuring study quality, regulatory compliance, and successful site performance throughout the clinical development lifecycle.
Working closely with investigators, sponsors, and cross-functional teams, the role supports the delivery of reliable data and impactful research outcomes.
The ideal candidate will combine clinical research expertise, strong organizational skills, and a commitment to Good Clinical Practice standards.
This is a fully remote opportunity within a collaborative environment focused on improving patient outcomes through innovative therapies.
The position provides opportunities for professional growth, mentorship, and continued development within a global clinical research organization.

The Senior Clinical Research Associate will oversee clinical site management activities and ensure studies are conducted according to protocols, regulatory requirements, and quality standards. This role requires strong attention to detail, effective stakeholder communication, and the ability to manage multiple study activities throughout the clinical trial lifecycle.

• Serve as the primary contact for assigned clinical study sites and maintain strong relationships with investigators and site teams.
• Conduct monitoring visits, including pre-study visits, site initiation visits, interim monitoring visits, and close-out visits, ensuring compliance with monitoring plans, SOPs, and ICH-GCP guidelines.
• Support study start-up activities, including feasibility assessments, site selection, regulatory documentation, and site activation processes.
• Review, collect, and maintain essential regulatory documents, investigator site files, and trial master files according to applicable procedures.
• Monitor patient enrollment activities and support site-specific strategies to improve recruitment and retention.
• Ensure proper handling, storage, accountability, and documentation of investigational products and trial materials.
• Perform remote monitoring activities and use clinical trial systems and reports to track study progress, data quality, documentation status, and compliance.
• Identify site performance issues, implement corrective actions, and escalate risks when necessary.
• Collaborate with Clinical Data Management teams to support data review and cleaning activities.
• Participate in investigator meetings, client meetings, project team discussions, and study-specific training sessions.
• Support the preparation and review of clinical study documents, including case report forms, monitoring plans, patient information materials, and informed consent documentation.
• Assist regulatory and ethics submission activities when required, ensuring timely approvals and communication with relevant stakeholders.
• Provide updates on site status, enrollment progress, risks, and milestones to clinical project leadership.
• Support contract discussions, investigator payments, and site payment tracking when applicable.

The ideal candidate will bring clinical monitoring experience, strong knowledge of clinical research regulations, and the ability to work independently while collaborating with global teams. A background in healthcare, life sciences, or clinical research is essential.

• Minimum of 1 year of clinical trial monitoring experience or equivalent relevant experience.
• Bachelor’s degree or higher in a healthcare-related discipline such as nursing, pharmacy, health sciences, or natural sciences, or equivalent clinical experience.
• Registered Nurse (RN) qualification with relevant clinical experience, or equivalent professional background considered.
• Previous experience conducting clinical research studies within a hospital, pharmaceutical company, or Contract Research Organization (CRO) environment.
• Demonstrated experience performing site monitoring activities, preferably with at least one year of on-site monitoring experience.
• Strong understanding of clinical research processes, ICH-GCP guidelines, regulatory requirements, and SOP compliance.
• Excellent organizational skills with the ability to manage multiple priorities, timelines, and study requirements.
• Strong written and verbal communication skills with the ability to collaborate effectively with investigators, sponsors, and internal teams.
• Ability to identify issues, apply sound judgment, and implement solutions in a clinical research environment.
• Proficiency with clinical trial systems, documentation tools, and standard office applications.
• Commitment to maintaining high-quality standards and protecting patient safety throughout the research process.

• Competitive compensation package, including eligibility for a sign-on bonus of up to $10,000.
• Fully remote work opportunity with flexibility and support for work-life balance.
• Comprehensive health benefits and vacation packages.
• Paid parental leave and programs supporting employee well-being.
• Structured mentoring programs and leadership development opportunities.
• Tuition reimbursement and access to ongoing training resources.
• Opportunity to contribute to research programs that help bring life-changing therapies to patients.
• Supportive global team culture focused on collaboration, innovation, and professional growth.
• Employee engagement initiatives and community programs promoting positive impact.