Clinical Research Associate I

Site ManagementConducts site initiation, monitoring, and close-out visits.Ensures compliance with study protocols and regulatory requirements.Manages site performance and resolves issues.Supports participant coordination and visit management, including scheduling, visit reminders, and reimbursement processes under PI or senior staff oversight.Coordinates with clinical staff for specimen collection and protocol-required procedures.Data Collection and ManagementCollects and verifies data from clinical sites.Ensures accurate and timely data entry into electronic data capture systems.Reviews and resolves data queries.Assists with quality control and maintains study binders and source documentation in accordance with GCP and FDA regulations.Regulatory ComplianceEnsures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.Prepares and maintains regulatory documents.Coordinates with ethics committees to safeguard participant rights.Supports regulatory start-up activities and assists with IRB amendments under supervision.Participant Recruitment and RetentionEvaluates medical records and performs screenings to identify eligible study participants.Assists in screening and enrolling study participants.Maintains communication with participants to ensure retention.Addresses participant concerns and queries.Supports recruitment outreach and preliminary screenings under guidance of senior staffReporting and DocumentationPrepares study reports and documentation.Maintains accurate records of study activities.Assists in the preparation of manuscripts and publications.Marginal or Periodic FunctionsConducts literature reviews to support study design and protocol development.Assists in the training of new site staff and research team members.Participates in internal and external audits.Supports the development of study protocols and case report forms.Attends conferences and workshops to stay updated on industry trends.Performs other tasks as assigned to support research team and project goalsAdheres to internal controls and reporting structure.Performs related duties as required.Knowledge/Skills/AbilitiesDouble-checks work for errors, maintains organized records, and follows detailed procedures.Writes clear and concise reports, actively listens to others, and presents information effectively.Analyzes information, develops solutions, and implements corrective actions.Shares information, supports team decisions, and contributes to team success.Prioritizes tasks, sets realistic deadlines, and uses time efficiently.Basic proficiency in Microsoft Office Suite (Word, Excel, Outlook). Familiarity with data entry platforms such as REDCap or ability and willingness to learn.Demonstrated ability to collaborate effectively with participants, clinical staff, and research teams.Detail-oriented with strong time management; able to follow protocols and maintain regulatory compliance.

Created: 2026-03-23