Senior Clinical Research Associate Resume Example Covance

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 AssociateCovance | Michigan Center, MI

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 IISynteract | CHICAGO HEIGHTS, IL

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 AssociateSynteract | Chicago, IL

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, Benin City

Resume Overview

Companies Worked For:

Covance
Synteract

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

Senior Clinical Research Associate Resume Example

Resume Score: 80%

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