Accomplished Clinical Research Associate with over 3years experience in performing and documenting pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies in accordance with good clinical practices, study-specific requirements, clinical monitoring plans, company procedures, applicable regulatory requirements and defined quality standards. Clear communication when working with internal teammates and external contacts.
• Excellent knowledge of monitoring procedures, GCP-ICH guidelines and
• Knowledge of medical terminology.
• Excellent time management, communication and interpersonal skills.
• Performs 60% to 80% travel.
• Excellent computer skills and great organizational skills.
• Multi-tasks, hardworking and quick learner.
• Detail oriented, deadline driven and always on time.
• Performs and documents pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close-out visits per GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards.
• Assists in Investigator selection and qualification process.
• Assists in development of Patient recruitment strategy.
• Conducts all activities according to defined project-specific performance and quality standards, ICH/GCP, SOPs, and local requirements.
• Ensures site IRB approval is current and all IRB documentation is in order.
• Maintains site monitoring schedule and serves as principal point of contact for investigational sites.
• Actively participates in training sessions and workshops, including presenting reports from any conferences attended.
• Documents and reports on clinical study progress, i.e. Patient recruitment and discuss potential opportunities and risks with respective Project Team members.
• Ensures Patient safety is maintained and informed consent procedures are carried out.
• Attends Investigator Meetings.
• Provides training and update investigative site teams of any changes in study conduct and documentation requirements.
• Ensures continued acceptability of investigator, clinical site team and facility.
• Reviews clinical data, source documentation, CRF, and investigative site regulatory files.
• Works closely with data management and site to resolve discrepancies.
• Ensures investigational product accountability accuracy and oversee investigational product inventory.
• Submits routine monitoring visit reports and follow-up letters as per required timelines.
• Ensures resolution of issues with investigative sites.
• Attends meetings as assigned and report on actions.
• Participates in educational activities and programs.
• Maintains strictest confidentiality.
• Assists other staff as requested and perform other related work, as needed. Ensures appropriate communication and study conduct.
• Assist other staff as requested and perform other related work, as needed.
• Functions as mentor for team members.
• Maintains awareness of current developments in therapeutic area relative to assigned projects.
• Performs all types of monitoring visits including Pre-study visits, Initiation visits, Interim Monitoring Visits and closeout visits
• Provides site management and monitoring support for sponsored studies.
• Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
• Completes visit reports in accordance with monitoring plans
• Participates in site training during Investigator Meetings.
• Performs source data verification, drug accountability, query generation
• SAE verification and reporting oversight, regulatory file review and
oversight, document submission for central archiving, monitor reports, general site support and communication
• Provide support to site in issue resolution and problem solving to achieve process improvement.
• Perform training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists.
• Monitor drug inventory, dispensing, compliance and return.
• Track and report site enrollment, progress, and adverse events.
• Ensure that regulatory documents are complete and in compliant with ICH
GCP and protocol.
• Ability to travel nationally and up to 80%
• Complete Follow Up Letters from all visit types according to SOPs and complete reports according to quality standards within company specified timelines.
• Ensure Investigator and site adherence to study specific guidelines, timelines, ICH GCP's, and SOP compliance.
• Monitors patient safety on-site, ensuring that AEs and SAEs are properly documented and reported
• Participates in Investigator meetings and other types of team meetings and assist in presentations
• Conducted clinical trials with investigational drugs according to GCP; ICH guidelines.
• Assisted Principal Investigator (PI) in completion of study feasibility assessments as requested.
• Monitored patients by performing vital signs, ECG and blood work.
• Maintained open-channel of communication with Sponsor as well as patients.
• Entered data into EDC
• Resolved issues identified by CRAs.
• Consented several Subjects prior to participation in clinical trials.
• Screened Subjects for eligibility against protocol specific inclusion and
• Prepared Regulatory materials for prompt submission to IRB. Maintained
inventory and processed, packaged and shipped lab specimens according to protocol.
• Recruited patients via phone screens for eligibility for various protocols.
• Responsible for sending appointment reminders to clinical trial Subjects.
• Provided protocol training to site staff members.
• Knowledge of FDA regulations, GCP/ISO 141155, ICH Guidelines, 21 CFR.
• Highly proficient with MS Office (Word, Excel, Outlook).
• Knowledge of Electronic Data Capturing Systems, CTMS & eTMF Systems.
• Comprehensive understanding of medical terminology, concurrent medications, and familiarity with patient records and documentation.
• Experience providing clinical protocol training or support for site staff.
• Ability to work well with internal and external customers.
• Creative problem solver coupled with sound judgment.
• High ethical standards.
• Independent work skills.
• Great attention to detail and accuracy.
• Ability to manage and prioritize multiple tasks and remain focused on personal objectives with minimal direction.
• Positive and flexible outlook.
• Strong interpersonal communication skills with ability to effectively communicate across all levels.
• Proven ability to work effectively independently and in multi-disciplinary team.
• Presents professional manner and appearance.
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