Clinical Research

• Lead assigned clinical research activities
• Partner with stakeholders, investigators and KOLs to develop study designs, concepts, protocols and study outlines
• Plan and execute pre-market and post-market clinical studies
• Manage site selection, patient recruitment projections, site start-up, enrollment and follow-up
• Prepare protocols, case report forms, informed consents, clinical trial agreements and study reports
• Organize IRB/EC submissions and follow through on study progress
• Conduct studies on schedule, within budget, with high quality and compliance
• Perform site qualification, initiation, interim monitoring and close-out visits, both on-site and remotely
• Conduct monitoring for regulatory and protocol compliance and data accuracy
• Complete source data verification in EDC systems, case report forms or data listings
• Liaise with sites and support internal audits, inspections and sponsor audit readiness
• Negotiate vendor and site contracts and budgets with legal and management
• Track study progress, provide status reports and manage site payments and financial tracking
• Collaborate with biostatisticians on data analysis, interpretation, clinical study reports and scientific publications
• Organize study meetings and activities
• Mentor junior clinical study managers and guide CRAs and CTAs
• Follow corporate SOPs, GCP and US/OUS regulatory guidelines
• Conduct literature searches, critically appraise scientific literature and write clinical summaries
• Review and revise Clinical Operations SOPs for process improvement
• Support post-market research, market-trend analysis and Health Economics and Outcomes Research activities
• Work with investigators on manuscripts, abstracts, slide presentations and posters
• Support regulatory submissions and approvals for pre-market studies and 510(k)s, including responses to regulatory questions

Senior Clinical Study Manager

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports
• Take responsibility for clinical trial monitoring deliverables and work collaboratively

Clinical Research Associate

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports
• Design and analyse clinical trials, interpret complex medical data, and contribute to innovative treatments and therapies

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment
• Review source documents and verify CRF data integrity
• Perform quality control and document verification for eTMF/TMF
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
• Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Assist with CRA training and onboarding
• Mentor CRAs
• Collaborate on Clinical Trial Management System (CTMS) development and maintenance
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

Senior Clinical Research Associate

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, study progress, and enrollment
• Ensure CRF data integrity through source document review and verification
• Perform quality control and verification of site documents for eTMF/TMF
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual
• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Collaborate with other CRAs
• Assist in CRA new-hire training and onboarding
• Mentor CRAs
• Collaborate on the development and maintenance of the CTMS
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

• Review assigned protocols and study documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, training, source documents, CRFs, laboratory workbooks, staffing, schedules, safety assessments, quality control, monitoring plans, pharmacy requirements, supplies, and regulatory documentation
• Support the Principal Investigator with delegation logs, daily tasks, visit calendars, monitor visits, and participant recruitment and screening
• Perform study activities according to Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data, complete Case Report Forms, submit data, and facilitate audits
• Coordinate screening and informed consent activities
• Supervise clinic visits, provide on-call support, screen eligibility, and oversee or perform study drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage clinic updates, adverse event and serious adverse event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate resolution of QC, monitor, CRF, and other findings
• Oversee study close-out documentation, deviations, CRF completion, TMF updates, logs, supplies return, IRB reports, and archiving
• Monitor participant compliance and escalate trial or study issues
• Prepare for and participate in sponsor, monitor, and QA audits
• Provide timely project status updates to Project Managers and sponsors
• Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
• Coordinate regulatory activities, including protocol, consent, amendment, and yearly renewal submissions
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties
• Travel up to 100%

Clinical Research Coordinator II – Oncology

• Review assigned protocols and related documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, Investigator Meetings, Site Initiation Visits, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, schedules, team training, source documents, CRFs, laboratory workbooks, staffing, and study supplies
• Confirm regulatory and contractual documentation before study start
• Support the Principal Investigator with delegation logs, daily task management, visit calendars, and monitor visits
• Advertise, recruit, and screen potential study participants
• Perform study activities in accordance with Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data; complete Case Report Forms and submit data on time
• Coordinate screening and assist with informed consent
• Facilitate study-data audits and respond to auditor data-clarification inquiries
• Coordinate clinic visits, including admission, dosing, randomization, discharge, and follow-up
• Provide on-call support when applicable
• Screen eligibility and oversee, coordinate, and/or perform study-drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage adverse-event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate QC, monitor, CRF, and other findings through resolution
• Oversee study close-out documentation, deviation reporting, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving
• Monitor participant compliance and escalate participant or study issues
• Prepare for and participate in sponsor, monitor, and QA audits
• Provide timely project-status updates to Project Managers and sponsors
• Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
• Coordinate and perform regulatory activities, including protocol, consent, amendment, and yearly renewal submissions when requested
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties

Clinical Research Coordinator II, Oncology

• Monitor and own the progress of clinical studies at investigative sites
• Ensure clinical studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, and applicable regulations and standards
• Coordinate activities required to set up and monitor studies
• Identify investigators and help prepare regulatory submissions
• Conduct pre-study and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical trials with clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Monitor and own the progress of clinical studies at investigative sites
• Ensure studies are conducted, recorded, and reported according to protocol, SOPs, ICH-GCP, applicable regulations and standards
• Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, pre-study visits and initiation visits
• Handle appropriately sized clinical trials
• Support larger clinical study teams
• Train and mentor junior staff members
• Interact directly with clients
• Initiate payments
• Participate in proposal activities, including development and client presentations

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
• Mentor and guide less experienced CRAs and site staff
• Document site visit findings via written reports
• Assess, monitor, and train study site staff on protocol adherence
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and data veracity
• Review CRFs using paper or electronic data capture systems
• Assist sites with data query resolution
• Provide updates for site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs