Clinical Research

• Oversee the planning, execution, and successful completion of clinical trials
• Ensure adherence to timelines, budgets, and regulatory guidelines
• Coordinate clinical trial management delivery, resolve issues, and develop team capability
• Oversee the clinical portion of the budget and ensure efficient resource allocation
• Develop monitoring plans and tools to ensure effective study oversight
• Train and mentor Clinical Research Associates (CRAs)
• Drive enrollment and lead study start-up activities
• Review trip reports and implement corrective and preventative action plans when necessary
• Foster productive relationships with Sponsors, vendors, and cross-functional teams
• Provide strategic guidance to drive successful clinical trial outcomes

Senior Clinical Trial Manager

• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out visits
• Complete site visit deliverables according to monitoring plans, timelines, regulatory requirements, SOPs, and ICH GCP
• Assist with study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Complete required general and study-specific training
• Participate in investigator, client, and project team meetings, including presentations
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation, and accountability of investigational products and trial materials
• Perform site management activities and provide site-status updates to the Clinical Project Manager
• Conduct remote monitoring according to study-specific monitoring plans
• Track subject status, CRF retrieval/source document verification, regulatory documents, and investigational products using systems and reports
• Support project-specific activities as a Project Team member
• Participate in developing CRFs and other study-related documents
• Translate, customize, and review patient information sheets, informed consent forms, protocol synopses, and other applicable documents
• Support Regulatory Affairs Study Start-up with submissions to ethics committees, regulatory authorities, competent authorities, and institutional boards where applicable
• Provide regular updates to sponsors/clients
• Support site contract negotiations, investigator payments, and site-payment tracking where applicable
• Manage investigator site files and trial master files for assigned sites
• Identify and anticipate site issues, implement corrective actions, or escalate as appropriate
• Liaise with Clinical Data Management on data-cleaning activities
• Mentor and train CRAs, including conducting training/assessment visits
• Function as Lead CRA for assigned projects

Clinical Research Associate II

• Ensure the development of clinical development strategies within established timelines and budgets, assessing efficacy and safety for registration, registration renewal, or clinical data generation
• Assist in preparing protocols for Phase I, II, III, and IV clinical studies
• Execute clinical development activities for protocols, incorporating decision points and criteria in collaboration with the team and management
• Collaborate with internal stakeholders to prepare clinical development plans aligned with regulatory requirements and Marketing and Commercial needs
• Prepare responses to regulatory authority requests related to clinical data
• Assist in preparing the final clinical study report with scientific quality
• Assist in preparing clinical registration dossiers and support regulatory, ethical, and health authority approval processes
• Review package insert text related to Clinical Research data
• Support high-level project planning and prepare Standard Operating Procedures (SOPs)
• Collaborate with the Clinical Research team, internal peers, CROs, research sites, and other partners
• Assist with due diligence processes and the evaluation of potential partners
• Develop clinical development proposals during the conceptual and economic feasibility assessment of projects

Clinical Research Development Analyst

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with approved protocols
• Communicate with medical site staff, including coordinators, clinical research physicians, and site staff
• Verify investigator qualifications, training, resources, facilities, laboratories, equipment, and staff
• Verify medical records and research source documentation against case report form data
• Inform site staff of entry errors and ensure good documentation practices
• Communicate protocol deviations according to SOPs, GCP, and applicable regulatory requirements
• Verify that investigators enroll only eligible subjects
• Review regulatory documents
• Manage investigational product/drug accountability and inventory
• Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses for accurate protocol-compliant reporting
• Assess site patient recruitment and retention and offer improvement suggestions
• Complete monitoring reports and follow-up letters summarizing findings, deviations, deficiencies, and recommended compliance actions
• Participate in clinical research departmental core rotations and drug/device development training

Senior Clinical Research Associate – Remote

• Oversee the clinical portion of the budget to ensure efficient resource allocation.
• Develop monitoring plans and tools, ensuring effective study oversight.
• Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
• Drive enrollment and lead study start-up activities, adhering to timelines.
• Review trip reports and implement corrective and preventative action plans when necessary.
• Foster productive relationships with Sponsors, vendors, and cross-functional teams.
• Identify and mitigate risks.
• Provide comprehensive reporting on all clinical activities.