Senior Clinical Research Associate Resume Examples and Templates

Senior Clinical Research Associate

• Analyzed extensive data from 100+ study subjects to maintain protocol integrity
• Liaised with all study sites regarding protocol deviations, data, and resolutions
• Produced and conveyed administrative and clinical trial data reports to key departments
• Conducted software testing for international medical research, facilitating study commencement
• Reported data and site status to CEO, COO, and Vice President.

Senior Clinical Research Associate

• Support Clinical Trial Leaders in project management, including vendor oversight, site establishment, budget management, and study tool development.
• Establish and manage eTMF (electronic Trial Master File).
• Assume the role of Lead CRA for specific trials.
• Lead the initiation of studies to prepare sites for enrollment.
• Participate in process enhancement initiatives.
• Perform ongoing monitoring and site management to ensure adherence to protocol, GCP, and global/local regulations.
• Provide guidance and mentorship to new CRAs.

Senior Clinical Research Associate

• Performed site initiation, interim monitoring, and close-out visits for multiple global trials.
• Evaluated the quality and integrity of study site practices in accordance with ICH/GCP standards.
• Oversaw 40 protocols and 55+ sites.
• Collaborated closely with laboratories across various sites and therapeutic domains to meet project requirements.
• Tracked the advancement of assigned studies, including regulatory submissions, recruitment, enrollment, and resolution of data queries on case report forms (CRF).

Senior Clinical Research Associate

• Plans and oversees trial tasks, providing leadership to ensure staff adhere to policies, procedures, and SOPs, and oversees HR processes.
• Acts as a Preceptor for new CRAs.
• Functions as a subject matter expert for CTM on monitoring-related activities and handles complex studies.
• Provides leadership within Clinical Operations and on assigned projects.
• Executes and monitors clinical trials for compliance with local regulations and ICH-GCP guidelines, ensuring sponsor and investigator obligations are met.
• Evaluates potential investigative sites, initiates and closes clinical trials, and instructs site personnel.
• Reviews and verifies clinical trial data accuracy, communicates site status, and maintains trial management tools.
• Completes monitoring activity documents per PRA SOPs and contractual obligations.
• Collaborates with clinical team members to resolve trial and site issues, escalating per PRA SOPs.
• Performs essential document reconciliation, source document verification, and query resolution.
• Ensures compliance with SAE reporting and communicates with sites, updating tracking systems and assisting in audits.
• Manages required training, mentors junior CRAs, and serves as a resource for new employees.
• Acts as an observation and performance visit leader.
• May handle additional Clinical Operations tasks requiring negotiation skills and collaborate with other functional areas to resolve site issues and meet trial timelines.

Senior Clinical Research Associate

• Escalated site and trial-related issues as per SOPs, ensuring resolution or closure of identified issues.
• Led observation and performance visits.
• Oversaw clinical trials to ensure compliance with local regulations and ICH-GCP guidelines, meeting sponsor and investigator obligations.
• Conducted essential document site file reconciliation.
• Managed and documented required training.
• Acted as subject matter expert for CTM on monitoring-related activities, handling complex studies/sites.
• Regularly provided site status updates to team members and trial management, updating tools accordingly.
• Mentored junior CRAs and supported new employees as a resource.
• Served as a Mentor for new CRAs in the CRA ACE Program.
• Completed monitoring activity documents per SOPs and contractual obligations.
• Verified Serious Adverse Event (SAE) reporting in accordance with trial specifications and ICH-GCP guidelines.
• Provided leadership within Clinical Operations and on assigned projects.
• Collaborated with clinical team members to expedite resolution of trial and clinical issues.
• Delivered services to clients with leadership and ensured staff adhered to policies, procedures, and SOPs.
• Evaluated IP accountability, dispensation, and compliance at investigative sites.
• Operated autonomously with minimal oversight.
• Reviewed and verified clinical trial data for accuracy, either on-site or remotely.
• Conducted source document verification and resolved queries.
• Interacted with other functional areas to resolve site issues and maintain trial timelines.
• Assessed the qualification of potential investigative sites, initiated and closed clinical trials, and instructed site personnel.
• Ensured adherence to Good Clinical Practices, investigator integrity, and compliance with study procedures through on-site monitoring visits.
• Confirmed staff compliance with responsibilities as per policies, procedures, and SOPs.
• Prepared monitoring reports and letters using approved forms and reports in a timely manner.
• Validated source documentation as required by the sponsor.

Senior Clinical Research Associate

• Managed site and trial-related issues per SOPs, ensuring resolution or closure.
• Led observation and performance visits.
• Oversaw clinical trials for sponsor and investigator compliance with local regulations and ICH-GCP guidelines.
• Conducted essential document site file reconciliation.
• Ensured completion and documentation of required training.
• Acted as subject matter expert for CTM on monitoring-related activities, handling complex studies/sites.
• Regularly provided site status updates to team members and updated trial management tools.
• Mentored junior CRAs and supported new employees as a resource.
• Served as a Mentor for new CRAs in the CRA ACE Program.
• Completed monitoring activity documents per SOPs and contractual obligations.
• Verified Serious Adverse Event (SAE) reporting in accordance with trial specifications and ICH-GCP guidelines.
• Provided leadership within Clinical Operations and on assigned projects.
• Collaborated with clinical team members to expedite resolution of trial and clinical issues.
• Delivered services to clients with leadership.
• Assessed IP accountability, dispensation, and compliance at investigative sites.
• Operated independently with minimal oversight.
• Reviewed and verified clinical trial data for accuracy, either on-site or remotely.
• Conducted source document verification and resolved queries.
• Interacted with other functional areas to resolve site issues and maintain trial timelines.
• Assessed the qualification of potential investigative sites, initiated and closed clinical trials, and instructed site personnel.
• Ensured adherence to Good Clinical Practices, investigator integrity, and compliance with study procedures through on-site monitoring visits.
• Verified staff fulfillment of responsibilities as per policies, procedures, and SOPs.
• Prepared monitoring reports and letters using approved company/sponsor forms and reports in a timely manner.
• Validated source documentation as required by the sponsor.

Senior Clinical Research Associate

• Achieved site recruitment targets within allocated timeframes.
• Ensured adherence to the project management plan for all study execution activities.
• Conducted follow-ups with sites and conveyed information to internal/external stakeholders.
• Maintained and updated trackers regularly, communicating changes to the project manager.
• Complied with the monitoring plan, coordinating with study sites and performing site monitoring.
• Promptly escalated issues at the site level when necessary.

Senior Clinical Research Associate

• Oversee 20 protocols across 45 sites.
• Take charge of study start-up and enrollment activities.
• Lead site selection, initiation, and monitoring for three SARS-COV-2 therapeutic trials.
• Collaborate with Medical Science Liaisons, Medical Directors, Global Trial Leads, and Data Managers to ensure protocol adherence, address site inquiries, and oversee accurate data entry at the site level.