Clinical Research Associate I

Site Management and Study ExecutionConduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.Ensure compliance with study protocols and regulatory requirements.Manage site performance and resolve issues.Administer questionnaires, collect medical history, and perform study procedures.Maintain rapport with participants to support retention and address concerns.Obtain informed consent and ensure participant safety throughout protocol procedures.Coordinate with affiliated departments and external collaborators.Data Collection and ManagementCollect and verify data from clinical sites.Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).Review and resolve data queries.Assist with manuscript and grant preparation, including opportunities for authorship.Maintain and update study databases and data collection forms.Regulatory Compliance and OversightEnsure 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.Prepare and maintain regulatory documents.Coordinate with ethics committees to safeguard participant rights.Participate in internal and external audits and protocol reviews.Participant Recruitment and RetentionEvaluate medical records and perform screenings to identify eligible study participants.Assist in screening and enrolling study participants.Maintain communication with participants to support retention.Address participant concerns and inquiries.Reporting and DocumentationPrepare study reports and documentation.Maintain accurate records of study activities.Assist in the preparation of manuscripts and publications.Marginal or Periodic FunctionsConduct literature reviews to support study design and protocol development.Assist in training new site staff and research team members.Participate in internal and external audits.Support development of study protocols and case report forms.Attend conferences and workshops to stay updated on industry trends.Adhere to internal controls and reporting structure.Perform related duties as required.Knowledge, Skills, and AbilitiesMaintain organized records, follow detailed procedures, and double-check work for accuracy.Write clear and concise reports, actively listen, and present information effectively.Analyze information, develop solutions, and implement corrective actions.Collaborate with team members and support team decisions.Prioritize tasks, set realistic deadlines, and manage time effectively.