Senior Clinical Research Associate Resume Example
Love this resume?Build Your Own Now
SENIOR CLINICAL RESEARCH ASSOCIATE
Professional Summary
Detail-oriented Senior Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Work History
02/2009 to 07/2020Senior Clinical Research AssociateInc Research Inc | Rico , CO
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
- Implemented electronic data capturing systems to adhere with clinical research guidelines
- Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development
- Managed project risk by identifying, quantifying and monitoring potential threats
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team
- Monitored unit budget to meet financial objectives for spend rate and funding
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
- Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives
- Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives
- Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals and case report form requirements
- Collected, evaluated and modeled collected data
- Maintained compliance with protocols covering patient care and clinical trial operations
- Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance
- Followed informed consent processes and maintained records
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Communicated project status to clinical management verbally and through technical documentation and presentations
01/2006 to 02/2009Clinical Research Associate IIClinical Research Management | Silver Spring , MD
- Instructed and supervised academic work of college students in classrooms and laboratories
- Conducted clinical trial in accordance with protocol and recorded and monitored progress
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team
- Liaised with clinical project leader to effectively resolve study-related issues
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding
- Supported development and delivery of department training to maximize success of clinical research
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials
- Implemented electronic data capturing systems to adhere with clinical research guidelines
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval
- Established drug trial methodologies and procedures to support business and clinical trial endeavors
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease
- Leveraged medical knowledge, expertise and problem-solving techniques to resolve investigative site issues
03/2003 to 01/2006Clinical Research AssociateAcumen Pharmaceuticals Inc. | City, State
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Conducted clinical trial in accordance with protocol and recorded and monitored progress
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding
- Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency
- Liaised with clinical project leader to effectively resolve study-related issues
- Observed clinical studies and assessed health outcomes in groups of participants to support research plan
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Established drug trial methodologies and procedures to support business and clinical trial endeavors
- Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication
Education
2000M.D. | Medicinal and Pharmaceutical ChemistryUniben, City
DISCLAIMER
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
How this resume score could be improved?
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
Resume Strength
- Completeness
- Measurable results
Resume Overview
School Attended
- Uniben
Job Titles Held:
- Senior Clinical Research Associate
- Clinical Research Associate II
- Clinical Research Associate
Degrees
- 2000 M.D. | Medicinal and Pharmaceutical Chemistry
Similar Resumes
