- A seasoned clinical research monitor with extensive experience in site management, site monitoring and clinical trial conduct over 3+ years in multiple therapy areas and across all phases of clinical research.
- Broad range of therapeutic experience
- Proficient in the technical/scientific knowledge required for comprehension and execution of clinical protocols
- Possession of the requisite organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budgets
- Superior written and verbal communication skills
- Ability to work in a matrix and fast - paced environment
- Demonstrated ability to train and mentor clinical research staff
- Ability to constructively interact directly with Sponsor personnel
- Computer literacy, including proficiency in MS Office, IVRS, CTMS and use of EDC systems
Clinical Research Associate
Confidential, Billerica, MA
- Support the site identification process and suggest sites to be considered for selection
- Conduct pre-study site visits and recommend sites per the site selection guidelines
- Provide assistance in the collection, review and tracking of essential pre-study documents as required.
- Conduct site initiation visits for selected sites to train the site personnel on the protocol and proper study conduct.
- Conduct monitoring visit to review source documents and case report forms to ensure that essential documents are current and complete and filed in the site’s regulatory binder.
- Ensure that all study drugs shipped to the site are properly accounted for and that subject is dosed correctly per the protocol and pharmacy guidelines.
- Identify deficiencies and/or discrepancies and provide additional training and/or initiate corrective action as required
- Follow-up with the site to assist in resolution of significant problems or issues noted during site monitoring visits.
- Conduct site closeout visits, as required and ensure that all study drugs are properly reconciled, to include test article reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents.
- Prepare comprehensive and detailed reports documenting study status, site issues and monitoring activities within specified timeframes.
- Communicate with study sites to ensure that all clinical aspects of the trial are adhered to in accordance with the protocol and Sponsor directives as well as state and federal regulations, guidelines and/or policies; provide on-going instruction to research site personnel, as necessary, on proper conduct of the trial.
- Ensure timely and proper completion of data by assigned clinical sites.
- Follow-up on safety issues at the site especially adverse events (AEs) and serious adverse events (SAEs) as necessary and reconcile SAEs with the clinical data.
- Assist in the resolution of data queries.
- Manage time, expenses and visit frequency per study guidelines.
Clinical Research Associate
Confidential, Cincinnati, OH
- Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies
- Monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH guidelines
- Provided regular clinical status information to team members and project management
- Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures
- Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff.
- Communicated common site trends to Lead CRA and other project team members
- Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
- Performed source document verification, retrieved Case Report Forms (CRFs) and performed query resolution in a timely manner and performed drug accountability and safety at investigative sites
- Ensured Serious Adverse Event (SAE) reporting according to project specifications
- Responded to requests from investigative sites in a timely fashion
- Mentored junior level CRAs and serves as a resource for new employees
- Served as a resource for and interacted with other functional areas to resolve site issues and facilitated project timelines
- Scheduled and reviewed project tasks, provided leadership in the delivery of services to clients, ensured that staff fulfilled their responsibilities in accordance with company policies, procedures, and SOPs, and ensured HR processes were properly implemented
Clinical Monitoring Associate
- Collaborated with CRA on site issues/actions
- Created and distributed study documents (e.g. eSignature Agreement, Amendments, etc.)
- Updated all relevant tracking system on an ongoing basis
- Maintained site staff details
- Performed regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS)
- Conducted remote visits (initiation, monitoring, termination)
- Collected updated/amended regulatory documents in collaboration with CRA and CTS as needed
- Reviewed recruitment plan and enrollment updates and addressed/resolved issues pending from the previous visit
- Addressed protocol questions and checked on site staff assignment
- Assessed drug/study supply status and requested outstanding documents
- Followed-up on data entry, query status and SAEs
- Maintained a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and specific procedure (e.g. Monitoring Plan)
- Created and executed product awareness plans and program through adequate product knowledge
- Maintained account relationship with medical doctors to ensure account retention
- Provided on the job training to pharmaceutical sales rep
- Effectively managed five sales reps to ensure the achievement of department’s target.
- Achieved outstanding increase in sales revenue within 12 month period (200%)