Clinical Research Associate Resume Example
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CLINICAL RESEARCH ASSOCIATE
Summary
Knowledgeable Clinical Research Associate with 4 years experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities with nursing experience. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Skills
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Experience
12/2017 - CurrentClinical Research AssociateAcutus Medical, Inc. | Carlsbad , CA
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Reported to project manager for issues related to overall study status.
- Checked electronic data capturing systems for integrity and compliance.
- Performed pre-study, closeout and interim visits to check on study activities.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
- Monitored site activities and sent follow-up letters to participants.
- Reviewed the site regulatory binder to check collection procedures and completeness of paperwork.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Obtained informed consent from research subjects and guardians to explain possible side-effects and potential outcomes of clinical research.
- Obtained site approval and compiled all vital documentation.
- Identified experienced investigator through careful assessment to oversee conduct of trial at trial site.
- Maintained strict confidentiality to keep all personal information and collected data private.
- Coached team members on best practices for conducting effective studies.
- Evaluated proof of eligibility and consent for participants.
- Spearheaded qualification, initiation, monitoring and close out visits by coordinating with project management team.
- Attended meetings and reported on activities and resolutions.
08/2017 - 07/2019Medical Surgical Registered NurseCornerstone Healthcare Group | Bossier City , LA
- Collaborated with multidisciplinary healthcare professionals to administer therapies and maintain continuum of care.
- Oversaw safety and compliance with patient confidentiality requirements.
- Participated in discussions with healthcare team members regarding surgical patients to address and resolve concerns.
- Oversaw treatments, therapies and medication administration according to prescribed methods and protocols.
- Performed comprehensive patient assessments to identify patient needs, devise individualized plans of care, modify care solutions and ensure patients' rights.
- Developed and implemented individualized care plans to meet each patients' unique needs.
- Delivered physician-ordered treatments and monitored responses to quickly spot complications and side effects.
- Assessed patients using comprehensive evaluation techniques and sound clinical judgment.
- Cared expertly for individuals with wide array of medical issues such as pulmonary, cardiology and infectious disease patients.
- Recorded any action or behavior of clinical significance in Epic, Cerner and Centricity EMR chart and kept physicians informed.
- Improved care outcomes with proactive education, communication and guidance for patients and family members.
- Advocated for patient needs with interdisciplinary team and implemented outlined treatment plans.
- Developed and adapted individualized treatment plans according to patient recovery goals.
- Responded to emergency situations with speed, expertise and level-headed approaches to provide optimal care, support and life-saving interventions.
- Monitored post-op vitals, set up PCA, fluids, reviewed post-op orders and assimilated patients to unit.
- Counseled patients and caregivers, providing emotional, psychological and spiritual support.
08/2012 - 07/2017Research Coordinator Aids Healthcare Foundation | New York , NY
- Kept organized records, maintained inventory equipment and materials.
- Collected, processed and delivered specimens from trial participants.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Obtained informed consent from research subjects and guardians to explain possible side-effects and potential outcomes of clinical research.
- Leveraged Epic to input and compile data gathered from various sources.
- Handled all delegated tasks, including subject recruitment and retention.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Conducted informed consent presentations and maintained documentation.
- Coordinated protocols by organizing and prioritizing all activities associated with studies.
- Gathered, prepared and maintained appropriate information required by GCP regulations and guidelines.
- Screened potential subjects to determine suitability for studies.
- Managed critical paperwork such as informed consent forms and personal waivers.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Education and Training
05/2017Bachelor of Science: Nursing
Chamberlain University of Nursing | City
Chamberlain University of Nursing | City
Bachelor of Science: Nursing
Georgia Perimeter College | City
Georgia Perimeter College | City
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Resume Overview
School Attended
- Chamberlain University of Nursing
- Georgia Perimeter College
Job Titles Held:
- Clinical Research Associate
- Medical Surgical Registered Nurse
- Research Coordinator
Degrees
- 05/2017 Bachelor of Science : Nursing
Bachelor of Science : Nursing
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