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Click here or scroll down to respond to this candidate Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE Street Address Birchwood Dr Nashville,NC
PROFESSIONAL SUMMARY
Experienced Senior Clinical Research Associate with a strong background in clinical trials
management, site monitoring, and protocol adherence. Proven ability to mentor and coach junior
CRAs, ensuring high-quality study execution. Core competencies include subject recruitment,
drug accountability, study coordination, data collection, quality assurance, data integrity, patient
safety, accurate reporting, and regulatory compliance. Detail-oriented and committed to
maintaining compliance with industry standards.
EXPERIENCE
Allucent, Cary, NC, USA 07/22-11/23
Sr Clinical Research Associate
Liaised with site staff to achieve patient recruitment targets
Completed PSV, SIV, IMV, COV, and remote monitoring visits ensuring study activity execution
in accordance with the study protocol, ICH/GCP guidelines, and SOPs
Provided site support in preparation for audit and required follow-up actions
Verified that source data and study database are accurate and complete
Verified Investigator Site File and TMF are maintained and up to date
Performed centralized and risk-based monitoring activities
Verified Serious Adverse Event reporting in accordance with trial specifications and ICH-GCP
guidelines
Icon 03/21-07/22
Sr Clinical Research Associate
Provided supplemental study development support during study start-up phase
Facilitated study start up activities aiding in timely site activation and IP shipment
Completed PSV, SIV, IMV, COV, and remote monitoring visits ensuring study activity execution
in accordance with the study protocol, ICH/GCP guidelines, and SOPs
Ensured audit readiness for internal, external, and site audits
Investigational Product accountability, reconciliation, return, or destruction
Verified Serious Adverse Event reporting in accordance with trial specifications and ICH-GCP
guidelines
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Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE 600 Birchwood Dr Nashville,NC
EXPERIENCE (CONTINUED)
PPD Inc. , Wilmington, NC 10/18-03/21
Sr Clinical Research Associate
Facilitated study start up activities aiding in timely site activation and IP shipment
Completed PSV, SIV, IMV, COV, and remote monitoring visits ensuring study activity
execution in accordance with the study protocol, ICH/GCP guidelines, and SOPs
Investigational Product accountability, reconciliation, return, or destruction
Ensured audit readiness for internal, external, and site audits
Performed centralized and risk-based monitoring activities
Verified Serious Adverse Event reporting in accordance with trial specifications and ICH-
GCP guidelines
IQVIA, Durham, NC, USA 01/16-10/18
Clinical Research Associate I/II
Completed PSV, SIV, IMV, COV, and remote monitoring visits ensuring study activity execution
in accordance with the study protocol, ICH/GCP guidelines, and SOPs
Investigational Product accountability, reconciliation, return, or destruction
Ensured audit readiness for internal, external, and site audits
Performed centralized and risk-based monitoring activities
Verified Serious Adverse Event reporting in accordance with trial specifications and ICH-GCP
guidelines
IQVIA, Durham, NC, USA 10/15-01/16
CRA Trainee
Completed therapeutic, protocol, and clinical research training per the established Early
Talent CRA Training Road Map.
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Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE 600 Birchwood Dr Nashville,NC
EXPERIENCE (CONTINUED)
IQVIA, Durham, NC, USA 01/14-10/15
Clinical Trials Assistant
Tracked enrollment status reports
Developed study-specific monitoring tools and forms for use by monitoring team
Prepared, handled, distributed, filed, and archived clinical documents into the eTMF
Completed study-specific training with project team
Assisted with periodic review of study files and completeness
Provided CRAs with outstanding data reports
Ensured audit readiness for internal, external, and site audits
Duke University Medical Center, Durham, NC, USA 03/12-12/13
Clinical Project Coordinator
Preparation and submission of protocol modifications to the IRB
Assisted in preparation of all documents related to the informed consent process.
Coordinated participant tests and procedures
Collected data as required by the protocol
Assisted the Principal Investigator in promptly reporting any unanticipated problems involving
risks to research participants or others to the IRB
Maintained adequate inventory of study supplies
Maintained effective and ongoing communication with sponsor, research participants and
PI during the study
Prepared study materials as requested by the PI including but not limited to case report forms,
enrollment logs, and drug/device accountability logs
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Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE 600 Birchwood Dr Nashville,NC
EXPERIENCE (CONTINUED)
Duke University Medical Center, Durham, NC, USA 11/09-03/12
Data Technician
Completed protocol required activities related activities
Screened subjects for eligibility using protocol specific inclusion and exclusion criteria
Completed patient payments, receipt collection, and documentation
Data Entry into EDC
Assisted project team in development and implement recruitment strategies
SKILLS
Clinical trial Document Informed
management Management Consent
Site monitoring Trial Master File Site Coordination
and compliance (TMF) Partner
Protocol Project Management Relationship
adherence Timeline Management Management
Data review and Regulatory Attention to
safety reporting Submissions detail
Team leadership eCRF Review Resourcefulness
and mentoring Record Keeping Strong
Communication
EDUCATION
Bachelor's in Health Service Management
East Carolina University 08/07-05/09
Bachelor's in Geography
08/07-05/09
University of North Carolina at Wilmington
Associate s in Medical Assisting
Pitt Community College 05/01-05/03
High School Diploma
DH Conley HIgh School 08/95-06/99
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Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE 600 Birchwood Dr Nashville,NC
THERAPEUTIC EXPERIENCE
Cardiology (1), specifically:
Observational phase trial: Obesity Clustering Risk Factors (Pediatric)
Endocrinology (2), specifically:
Phase I Diabetes Mellitus Type 1
Phase III Diabetes Mellitus Type 1
Gastroenterology (7), specifically:
Phase II Inflammatory Bowel
Phase III Inflammatory Bowel
Phase III Inflammatory Bowel
Phase III Ulcerative Colitis
Phase III Ulcerative Colitis
Phase III Short Bowel Syndrome
Phase III Short Bowel Syndrome
Genetic Disorder (1), specifically
Phase II Fragile X Syndrome
Genitourinary (2), specifically:
Phase I Congenital/Inherited Disorders Alport Syndrome (Pediatric)
Phase II Congenital/Inherited Disorders Alport Syndrome (Pediatric)
Gynecology (1), specifically:
Observational phase trial: Polycystic ovary syndrome (PCOS)
Hepatology (1), specifically:
Observational phase trial: Hepatitis C Immunology
Immunology (1), specifically:
Phase III Food Allergy (Pediatric)
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Candidate's Name
SENIOR CLINICAL RESEARCH ASSOCIATE
PHONE NUMBER AVAILABLE EMAIL AVAILABLE 600 Birchwood Dr Nashville,NC
THERAPEUTIC EXPERIENCE (CONTINUED)
Infectious Disease (2), specifically:
Phase III Chikungunya Disease
Phase III Ventilator-Associated Pneumonia (VAP)
Nephrology (4), specifically:
Phase I IgA Nephropathy
Phase III Chronic Renal Failure
Phase III Chronic Renal Failure
Phase III Chronic Renal Failures
Neurology (1), specifically:
Phase II/III Seizure Disorders-Epilepsy (Pediatric)
Ophthalmology (1), specifically:
Phase III Dry Eye
Psychiatry (1), specifically:
Phase I Dementia-Alzheimer's
Pulmonology (1), specifically:
Phase IIIb Asthma
Rheumatology (1), specifically:
Phase 1 Rheumatoid Arthritis
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