Independent/ Contractor Clinical Research Associate.
Independent/ Contractor Clinical Research Associate.
- Independent Clinical Research Associate at Bland Clinical Research Monitoring Services, LLC
- Quality Assurance/ Quality Control Associate at Pinnacle Clinical Research, PLLC
- Clinical Research Associate, II at Sarah Cannon, The Cancer Institute
- Senior Clinical Research Associate at Worldwide Clinical Trials, Inc
1 month at this Job
- BS - Education/Business Administration
- Certificate - Medical Assisting
Within various fields of clinical research, review patient reported trends. Provide written reports detailing client meetings. Use scientific protocols and study documents as a catalyst to write additional articles for processes. Meet with physicians, key decision makers, and healthcare staff to convey procedures required for participation in clinical trials. Develop initial procedures needed to successfully complete the research process. Create and deliver visual presentations of study protocols. Continuously review progress of clinical trial to completion. Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. Initiate and manage patient recruitment strategies. Continuously follow recruitment trends to ensure goals are met. Provide guidance to enhance patient recruitment. Serve as a colleague trainer. Utilize corporate measures to evaluate the effectiveness of internal staff. Meet with internal staff to discuss requirements necessary for future unaccompanied work. Provide pass/fail information to departmental heads. Contribute to the review of ICON systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Active member of Clinical Research Associate Rejuvenation team. Collaborate with a think tank team to discuss departmental issues. Responsible for evaluating trends in employee dissatisfaction. Provide solutions for employee retention while maintaining company compliance and best interests.
- Sr. Clinical Research Associate at ICON Clinical Research
- Presenter at ICON Clinical Research
- Lead Clinical Research Associate at INC Research, Inc
- Principal Researcher at Walden University
6 years, 5 months at this Job
- Doctor of Philosophy - Public Health Community Health Promotion and Education
- Master of Science - Health Services Administration
- Bachelor of Science - Biology
Clinical research associate scholar certified in 110 modules accredited by the ACCRE and CCRP in clinical research associate and clinical research monitoring roles.
- Certified Clinical Research Associate Scholar at CCRP
- Substitute/Special Education Assistant at ACTON BOXBOROUGH SCHOOL DISTRICT
- Medical Transcriptionist at MASSACHUSETTS CORRECTIONAL INSTITUTE
- Clinical Observer at SOUTH COAST PHYSICIAN GROUP Fall River & INTERNAL MEDICINE OFFICE
1 month at this Job
- Bachelor of Medicine And Bachelor of Surgery - Medicine And Bachelor of Surgery
• Perform all aspects of clinical research visits ranging from site qualification visits, initiation visits, routine monitoring visits to close out visits.
• Report study site conduct in a timely manner
• Establish and maintain good working relationship with site personnel's
• Ensure data integrity by instructing the site to answer queries and complete eCRFs in a timely manner according to Sponsor SOP
• Working with different types of EDC systems and performed remote monitoring.
• Submission of reports in a timely fashion
• Performs risk basked monitoring for various studies
• Monitors studies in Phase I and Phase II stages in accordance with applicable FDA guidelines, GCPs and SOPs
- Clinical Research Associate II at TFS - Clinical Contract Research Organization
- Clinical Research Associate at Boehringer-Ingelheim
- Clinical Data Associate at Boehringer-Ingelheim
1 year, 10 months at this Job
- Master of Arts in Human Resource Management - Human Resource Management
- Bachelor of Business Administration in Management - Management
• Assist with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing and maintaining proper status reports of activities at investigative sites through the duration of a clinical trial and completing other technical tasks to completion
• Qualify, initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors
• Assist and manage training of new Clinical Research Associate
• Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human and or animal subjects
• Ensure subject safety through diligent monitoring of the site's compliance with study protocols and the collection of adverse event information
• Update, track and maintain study specific trial management tools/system
• Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with investigational product handling procedures. Ensure that all adverse events are collected pursuant to GCP
• Report, write narratives and follow-up on reported serious adverse experiences
• Assist with generation and reconciliation of queries to investigation sites to resolve problem data
• Assist and manage project budget and investigator site budget as needed, attend project team meetings, plan, attend and participate in investigator meetings, and communicate with clients
• Generate and track investigational product shipments and storage
• Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director
- Clinical Research Associate at American Regent, Inc
- at Astrazeneca
- Document Quality Coordinator at Phlexglobal Inc
- eTMF Specialist at Covance Inc
6 months at this Job
- Master's in Public Health Administration - Health Care Management
- Diploma in Medical Assistant - Medical
- Bsc - Economics
Sept 2016- Current
The interaction between laboratory and clinic continues to generate new ideas and methods for the prevention and treatment of cancer.
Senior Clinical Research Associate (Contractor - JNP Clinical Consulting LLC)
• Monitoring and Site Management: Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol. Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability. Monitor completeness and quality of Regulatory Documentation and perform site document verification.
• Leadership in a Clinical Research Environment: Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action. Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication. Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
• Data Management and Reporting: Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. Ensure that assigned sites are audit and inspection-ready.
- Senior Clinical Research Associate at UNIVERSITY OF MARYLAND MEDICAL SYSTEM
- Senior Clinical Research Associate I at INC RESEARCH, LLC
- Clinical Research Associate I/II at UNIVERSITY OF MARYLAND MEDICAL SYSTEM
- Clinical Research Coordinator/Lead Clinical Data Manager at UNIVERSITY OF MARYLAND MEDICAL SYSTEM
2 years, 9 months at this Job
- Master of Public Health - Public Health
- Bachelor of Arts - Biological Sciences
• Expertise in Site Selection, Initiation, Periodic Monitoring, and Close-Out Visits for Phase I-III Clinical Studies
• Over 13 years’ experience in Oncology/Hematology Clinical Research Trials
• Other Therapeutic Experience: Women’s Health, Metabolic Disorders, Endocrine (Diabetes), and Stroke
• Consistently achieved study data timelines, verifying 90% of data points within 60 days
• Reviewed monitoring visit reports to proactively identify, document and resolve deficiencies relating to site's enrollment, study data and/or conduct
• Proficiently managed, addressed questions, and streamlined activities in all site-related issues for a global Phase III Oncology study, with particular focus in European and South American regions
• Directed the successful start up of a Phase I Oncology Study in the United States and Canada
• Lead Clinical Research Associate supervising 6 CRAs for a large women’s health study, ensuring study team adherence to timelines and budget
• Lead Clinical Research Associate for an International Phase III Metabolic Disorder study, overseeing 15 CRAs
• Experience in study start up activities: feasibility, study logistics, protocol, case report form, & study document development
• Strategically led a team in improving and developing company Standard Operating Procedures (SOPs) and templates within timelines
• Performed CRO oversight to assure protocol compliance across all company studies
• Mentored and trained new Clinical Research Associates
• Strong working knowledge of ICH, GCP and FDA Guidelines
• Experience with Electronic Data Capture including RAVE (iMedidata) and InForm
• Experience with IVRS and Clinical Trials Management Systems
• ACRP Certified CRA for over 15 years
- Senior Clinical Research Associate at Seattle Genetics
- Site Network Manager at
- Senior Clinical Research Associate at
- Manager at Emphusion
3 years, 5 months at this Job
- Masters - Health Science
- Bachelor of Science - Policy & Administration
Key Responsibilities: Clinical Research Associate
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of Work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites to manage ongoing projects expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulation. Escalate quality issues to Project Manager (PM), Clinical Lead (CL) and/or Site & Resource Manager (SRM)
• Manage the progress of assigned studies by tracking regulatory submission and approvals, and recruitment and enrollment, case report form (CRF) completion and submission and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and other required study documentation.
• May provide assistance to less experienced clinical staff. Non-IQVIA Employment History
- Clinical Research Associate at IQVIA
- Senior Clinical Research Coordinator at ALPHA NEUROLOGY P.C
- Senior Clinical Research Coordinator at MEDICAL PSYCH CARE, PLLC
- Student at Educational Leave
7 months at this Job
- - Bacheolar of Medicine & Bacheolar of Surgery
• Supports Project Teams with the management of research studies from study initiation through close-out activities (informed consent development, data and query management and investigational site management).
• IRB/EC management including site application assistance and approval tracking.
• Responsible for the compilation and maintenance of site regulatory documentation.
• Adheres to good clinical practices, study protocols, and applicable regulations.
• Preparation of study progress reports for project team and sponsor.
• Preparation for safety management review meetings (e.g., binders, agenda preparation, and meeting minutes).
• Performs site qualification, site initiation, interim monitoring (remote and/or on-site) and study close-out activities of study centers for compliance with clinical protocol and applicable regulations.
• Responsible for the maintenance of study specific files and documentation.
• Reviews and manages clinical site payments.
• Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study/project.
• Ensures reported trial data are accurate and complete, and participates in clinical data processes, as needed.
- Clinical Research Associate II at Regulatory and Clinical Research Institute, Inc
- Clinical Trial Coordinator at Nuvaira, Inc
- Clinical Research Coordinator at Clinical & Translational Science Institute - U of M
- Clinical Trial Coordinator at Minnesota Lung Center/Minnesota Sleep Institute
1 year at this Job
- - Medical Assistant
- Bachelor's Degree - Liberal Arts
Regional Clinical Research Associate I
• Assessed site qualification potential; reviewed study requirements; conducted pre-study visits and drafts pre-study evaluation reports.
• Participated in the implementation of clinical studies: communicates with investigators and their staff; ensured compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.
• Supervised the conduct of clinical studies: acted as liaison between site personnel and the sponsor; performs monitoring in the field; ensured compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.
• Ensured the quality of the project: verified materials and data integrity; assisted site personnel with internal audits or regulatory inspections; and performed ongoing follow-up with the in-house project team.
• Adhered to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures.
• Verified the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation.
• Conducted Pre-qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-out Visits.
Regional Clinical Research Associate I
- Clinical Research Associate at Emissary CRO
- Lead Clinical Research Coordinator at Los Angeles Clinical Research
3 years at this Job
- Bachelor's - Business Administration