Clinical Research Manager
604 Harmony Lane
Pleasantville, CA 94588
CLINICAL RESEARCH MANAGER / CLINICAL TRIALS PROJECT MANAGER
Dynamic research career with extensive recent focus on clinical trial establishment, clinical trial management, and related clinical research background, building on multiple direct and transferable skills/knowledge in these areas:
• Clinical Trials/Management • Monitoring Reports/Clinical Study Forms
• SOP Implementations • Source Documentation Verification
• ICH Guidelines/GCP Expertise • Investigator Brochures
• Phase I, II, III Studies • Investigator Meetings
• Study Designs • Quality Assurance Audits
• Protocol/Study Procedures Manuals • FDA Audit Issues
SUMMARY OF QUALIFICATIONS
• Strong knowledge of project leadership and clinical data management, clinical trials and related areas from four years of experience with Cato Research in a clinical research management role
• Selected certifications include ACRP Certified (CCRA) with analytical and medical research experience.
• Maintain a broad scope of knowledge to identify and pursue possible solutions to problems. Creative problem-solving and critical thinking skills.
• Significant training, continuing education and knowledge of regulatory requirements and ICH guidelines.
• Two years of Clinical Nursing experience provides a strong medical foundation and a variety of transferable skills. Knowledge of therapeutic areas include: oncology, pediatric and adult respiratory, endocrinology and women's health; have worked on multiple projects as a CRA and CRM in these areas.
• Research experience includes outstanding ability to analyze, gather, write, evaluate and produce detailed reports on a variety of projects. Expertise in collecting, review and production of critical documents.
• Excellent written, verbal and interpersonal communication skills Comfortable speaking with RNs, MDs, study coordinators and clinic directors.
• A team-oriented professional who works well under pressure, is goal oriented, with a commitment to exacting research.
• Professional experience has provided exposure to: drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, validation, personnel management.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Successfully interact with sponsors, team members, and senior management.
• Supervise and manage internal and external personnel to ensure timely initiation and completion of clinical studies and various clinical documents including those submitted to regulatory agencies Consistently projected and operated within study budgets.
-CLINICAL RESEARCH, Research Triangle Park, NC
2001 - Present
Clinical Research Manager
- Led key clinical therapeutic areas of Oncology, Respiratory, Endocrinology, and Women's Health.
- Directly managed 15 employees and worked with 35 CRAs in scheduling projects as well as directing CRAs on project teams that have led to 12 published papers internally and externally.
- Promoted from a Certified CRA to CRM I and currently to a CRM II.
• Responsible for the daily activities involved in clinical trials, manage the direction, planning and implementation of clinical research trials. Key team member for proper study execution, which includes recruitment and enrollment strategies, oversight of monitoring activities, study conduct, compliance with regulatory standards, and completion of data transfers. Obtain and process adverse event data in accordance with Good Clinical Practice (GCP) and other regulatory guidelines. Prepare study-related documents and reports of trial progress. Serve as prime source of information and input into the design of protocol, Study Procedure Manuals, and Case Report Forms. Ensure effective follow-through on all assigned tasks as well as strategic delegation of tasks to qualified individuals.
1998 - 2001
Clinical Research Associate
• Monitored clinical studies, served as a liaison between the sponsor and sites, responsible for reviewing site contracts and budgets. Participated in project meetings and conference calls, traveled to study sites to supervise and coordinate clinical studies. Verified source documentation, accounting for CTM, ensuring compliance with GCPs and SOPs. Additional position responsibilities included: maintaining study files, monitoring and collecting adverse experiences, writing and reviewing site visit reports, serving as a key resource for site queries.
REPRODUCTION & ENDOCRINOLOGY ASSOCIATES OF THE SOUTH, Atlanta, GA
1996 - 1998
Fertilization Staff Nurse/Team Research Coordinator
Coordinated patient care management and the administration of informed consents. Scheduled laboratory and radiographic evaluations, interpret test results and track patients on a daily basis for response and protocol compliance. Specialized duties include all aspects of data management including nursing assessment of patient progress in source documentation, organization of patent data, related source documents and study files. Managed regulatory binders and completed case report forms. Maintained strict adherence to protocols, assisted with patient accruals, adverse event assessments and reporting, financial issues and other study requirements. Responsible for all aspects of investigational drug management including dispensation, accountability, inventory, record completion, and maintenance of appropriate control of investigational drugs in accordance with FDA guidelines. Collaborated with physician staff in case management of study patients on a daily basis. Served as liaison between physician staff and patients; served as primary contact.
GEORGIA STATE RESEARCH CENTER, Atlanta, GA
1992 - 1996
Coordinated and facilitated all aspects of busy student health clinical, including administration of immunization, interpretation and discussion of test results with student patients. Served as liaison for patients regarding student health issues with physicians, and customary nursing assistant patient care duties.
2003-ACRP Meeting, Washington, DC teleconference
2002-Essential Practices for Effective Clinical Trial Management - telecourse and onsite at Bowman-Gray Hospital, Wake Forest University, Winston-Salem, NC
GEORGIA INSTITUTE OF TECHNOLOGY, Atlanta, GA
Bachelor of Science, Nursing
State of North Carolina Nurse # 980309
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