Research Analyst

• Oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards
• Lead on clinical trial monitoring tasks requiring technical depth, focusing on quality and continuous improvement
• Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
• Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations

Senior Clinical Research Associate

• Perform monitoring and site management work to ensure proper conduct of study protocols.
• Conduct site monitoring visits in accordance with contracted scope of work and Good Clinical Practice.
• Collaborate with sites to drive subject recruitment plans.
• Administer protocol training and establish lines of communication with sites.
• Evaluate the quality and integrity of study site practices.
• Track regulatory submissions and approvals, enrollment, and data query resolutions.
• Ensure site documents compliance with GCP and regulatory requirements.
• Create and maintain documentation regarding site management and monitoring visit findings.
• Liaise with study team members for project support.

Senior Clinical Research Associate, Sponsor Dedicated

• Collaborate with team members to ensure all project deadlines are met and project logistics are accounted for
• Assist in all aspects of research across operational phases throughout the project, including survey proofing, data cleaning, data charting, data checking, recruitment updates, etc.
• Document client calls and internal meetings, including providing feedback to the relevant projects and ensuring documentation is shared with team for collaboration
• Support client deliverables by creating slides, identifying case studies, syndicated data and desk research that lend to the overall insights and narrative
• Manage logistical issues around fielding, data processing, vendors, etc., including identifying process improvements
• Proactively communicate availability/capacity/contributions to the team

Research Analyst – Custom Market Research

• Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
• Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
• Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
• Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution.
• Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations.
• Generate visit reports, follow-up letters, and other necessary documentation.
• Mentor clinical staff through co-monitoring and training visits.
• Work closely with study team members to support project execution.

Senior Clinical Research Associate, Oncology

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent and reporting potential safety-related events
• Collaborate with top-tier colleagues from various backgrounds and specialties

Senior Clinical Research Associate – Oncology

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites
• Conduct pre-study and initiation visits
• Ensure informed consent procedures and protocol requirements are adhered to
• Monitor data for missing or implausible data
• Complete Serious Adverse Event (SAE) reporting
• Assist with training of new employees

Clinical Research Associate II, Phase I

• Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
• Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
• Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
• Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
• Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
• Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
• Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation
• Serves as the liaison between Argenta US Clinical and study site personnel
• Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor
• Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
• Builds relationships with key individuals and contributors in the organization and beyond

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