This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Contract Senior Clinical Research Associate based in the United States.
This role is a key contributor to the execution and oversight of clinical trials across pharmaceutical, biotech, and medical device studies. You will be responsible for ensuring that clinical research activities are conducted in full compliance with study protocols, GCP guidelines, and applicable regulatory requirements. Operating in a highly collaborative and mission-driven environment, you will conduct site monitoring visits, support investigator sites, and ensure the integrity, accuracy, and completeness of clinical trial data. The position involves close interaction with study coordinators, investigators, and cross-functional project teams, making strong communication and relationship management skills essential. You will also play a vital role in identifying and resolving data discrepancies, supporting regulatory documentation, and maintaining high-quality trial master files. With significant travel required, this role offers exposure to a wide range of clinical settings and therapeutic areas. It is an opportunity to directly contribute to the advancement of treatments that improve patient outcomes and global health.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Contract Senior Clinical Research Associate based in the United States.
This role is a key contributor to the execution and oversight of clinical trials across pharmaceutical, biotech, and medical device studies. You will be responsible for ensuring that clinical research activities are conducted in full compliance with study protocols, GCP guidelines, and applicable regulatory requirements. Operating in a highly collaborative and mission-driven environment, you will conduct site monitoring visits, support investigator sites, and ensure the integrity, accuracy, and completeness of clinical trial data. The position involves close interaction with study coordinators, investigators, and cross-functional project teams, making strong communication and relationship management skills essential. You will also play a vital role in identifying and resolving data discrepancies, supporting regulatory documentation, and maintaining high-quality trial master files. With significant travel required, this role offers exposure to a wide range of clinical settings and therapeutic areas. It is an opportunity to directly contribute to the advancement of treatments that improve patient outcomes and global health.
Accountabilities:
- Conduct clinical monitoring activities including qualification, initiation, interim, and close-out visits across assigned study sites.
- Ensure clinical trials are executed in compliance with study protocols, SOPs, ICH-GCP guidelines, and regulatory requirements.
- Train and support site personnel on protocol requirements, therapeutic areas, source documentation, and case report form (CRF) completion.
- Monitor investigational product handling, including dispensing, reconciliation, inventory tracking, and documentation.
- Review laboratory sample collection, storage, and shipment processes to ensure compliance and accuracy.
- Evaluate study progress including enrollment, protocol deviations, adverse events, and data quality issues.
- Perform source data verification and ensure accuracy, completeness, and integrity of clinical trial data.
- Manage data queries, resolve discrepancies, and maintain effective communication with study sites and stakeholders.
- Review regulatory documents and support sites in resolving compliance-related issues.
- Maintain complete and audit-ready study documentation and trial master files.
- Serve as a point of contact for sites, investigators, and internal teams, ensuring consistent communication.
- Provide guidance and support to junior CRAs and contribute to team problem-solving.
- Bachelor’s degree, RN qualification, or advanced degree in biological sciences or related field, or equivalent combination of education and CRA experience.
- Proven experience as a Clinical Research Associate with demonstrated career progression.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes.
- Experience conducting site monitoring visits across all phases of clinical trials.
- Familiarity with pharmaceutical, biotech, or medical device clinical research environments.
- Excellent organizational skills with the ability to manage multiple studies and priorities simultaneously.
- Strong communication and interpersonal skills for effective collaboration with sites and cross-functional teams.
- High attention to detail and strong problem-solving abilities.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
- Ability and willingness to travel up to approximately 65%, including short-notice travel.
- Ability to work independently in a fast-paced, changing environment.
- Competitive contract-based compensation (aligned with experience and market standards)
- Opportunity to work across diverse clinical trials in pharmaceutical, biotech, and medical device sectors
- Significant travel exposure across multiple therapeutic areas and study sites
- Collaborative and mission-driven environment focused on advancing global health outcomes
- Exposure to high-quality clinical research processes aligned with industry-leading standards (GCP/FDA)
- Opportunity to strengthen expertise in clinical monitoring and regulatory compliance
- Work within a supportive structure that values professional growth and accountability.