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Clinical Research Associate Resume Samples
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0-5 years of experience
Increased number of accounts achieving company goal of 20% change rate, from 2 to 10 accounts within first two months of hire.
- Comprehensively analyzed all accounts helping determine more efficacious protocols thereby increasing compliance with specified registry.
- Dramatically increased education to physicians and staff of each account, increasing sales proportionately.
- Monitored appropriately the assigned clinical registry following company SOPs and in conformity with GCP.
- Responded effectively to protocol violations and afforded lab reports, pharmacist analysis, and productive recommendations to prescribers, resulting in maximization of patient care and minimization of associated costs from adverse drug reactions and or ineffective therapies.
0-5 years of experience
Trained, monitored, and supervised research-naïve sites to ensure protocol compliance and adherence to GCP
principles as part of a multi-centered dental practice-based research network
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- Collected, reviewed and maintained regulatory documents and performed IRB submissions
- Assisted in the development of protocols, case report forms, informed consent forms, and IRB materials
- Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data
- Increased network practitioner recruitment rate by nearly 150%
0-5 years of experience
Assigned 8 sites over three protocols on Major Depression Disorder study for a global Japanese client.
- Completed PSVs, SIVs, RMVs, and COVs per study requirements. RMV monitoring visit interval was 4-6 weeks.
- Completed full Site Management which entailed accounting for study medication in Clinphone system, Ensuring all data in CTMS is accurate, verifying drug accountability, completing drug inventory/ensuring drug maintained in locked limited access environment with temperature range /Temp Logs, completed 100% SDV, completed query reconciliation trained site staff on EDC system, protocol, GCP Guidelines, etc.
- All data sweep and interim analysis were met for my sites prior to closure.
- Completed Tables and Listings Reviewed
- Assisted in final closure of study.
0-5 years of experience
Performed initiation, study staff training, interim monitoring and close-out visits for multiple sites in accordance with SOPs and the CMP.
- Created and developed FDA compliant data management modules using Axis Clinical software products.
- Monitored 6-8 protocols with varying indications at multiple sites across the country to ensure adherence to the protocol and compliance with ICH guidelines, GCPs and FDA regulations.
- Thoroughly communicated with principal investigators and their staff members to resolve data
- Functioned as the primary point of contact between sponsor and 8-10 study sites around the country.
0-5 years of experience
Visited sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to terminate studies.
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.
- Performed investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
- Performed source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites
- Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.
- Generated reports for site and project management using CTMS.
- Required to travel 70% of the time.
0-5 years of experience
Delivered against sponsor obligations through successful implementation and monitoring of clinical trials compliant with applicable local requirements, FDA and GCP guidelines.
- Conducted monitoring visits for protocol compliance, personnel qualifications assessments and conducted close out visits
- Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate, current and identical to Trial Master File (TMF)
- Provided timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB
- Conducted un-blinded drug accountability visits, reviewed drug inventory and subject accountability records, inspected the storage area for study medication
- Facilitated escalation processes for elevating site or study issues in clinical monitoring with monitored reports for study site personnel and team members
0-5 years of experience
In-house CRA – conducted scientific review and analysis of data for pivotal Phase III studies for Type 1 Diabetes, Type 2 Diabetes and ESRD.
- Developed SOP on processing of samples for ANCA analysis.
- Reviewed lab reports and clinical data; contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.
- Provided technical information (Help Desk); aid in the ordering of clinical supplies to study site personnel.
- Assisted in on-site monitoring of clinical trials including review of source documentation, case report forms, regulatory materials and drug accountability.
0-5 years of experience
Collaborated in an extensive hands-on formulation development and performance
characterization.
- Demonstrated the ability to multi-task and manage different projects while delivering against aggressive goals.
- Effectively communicated project work results and plans to cross-functional teams
- Implemented methods for collecting high-quality quantitative and qualitative data,
- Evaluated suitability of prospective study candidates and recruited research participants
- Communicated all policies and procedures to research participants and responded to all
0-5 years of experience
- Traveled 70% – 80% to sites for on-site visits
- Reviewed monitoring reports and implemented follow-up or corrective action as needed
- Ensured study documentation is completely and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations
- Prepared and submitted of timely appropriate monitoring forms and site visit reports in accordance with the Project Operations Manual and SOPs
- Monitored Investigator compliance for the reporting of Adverse Events and Serious Adverse Events.
- Provided timely and accurate submission of time reports, expense reports, monitoring reports, and schedules
6-10 years of experience
Worked collaboratively with a Clinical Research Nurse to conduct several clinical research projects under the direction of five physicians.
- Developed procedures for recruitment, enrollment and data collection. Oversaw up to four students.
- Composed various IRB applications to conduct research. Created a system to manage IRB applications, amendments and renewals.
- Oversaw data collection and storage. Oversaw a large project to overhaul the storage of thousands of clinical samples and connect them with medical history through an Oracle-based database system.
0-5 years of experience
Wrote a protocol for a clinical study testing the safety and efficacy of an antidepressant.
- Designed case report forms for clinical studies.
- Initiated, monitored and closed out clinical investigational sites conducting research on investigational cardiovascular and antidepressant medications.
- Ensured investigators’ compliance to study protocols and federal regulations through review of patients’ medical records and investigators’ files.
- Wrote frequent reports detailing the progress of the studies, adverse events and conversations with site personnel.
- Determined payment schedules and arranged payment of study budgets to study sites.
- Reviewed protocols and case report forms during their development.
0-5 years of experience
Responsible for a multitude of critical, industry-sponsored studies, many of which occurred simultaneously
- Consulted with the Institutional Review Board to present study budgets, objectives and key milestones for study approval
- Effectively managed a variety of study aspects including budget oversight, patient screening, recruitment and patient/family counseling and education
- Administered medications and educated pediatric patients and families on required dosage, frequency and application technique
- Organized and maintained study documents including consent and assent forms, registries and patient charts
0-5 years of experience
Managed clinical study start-up, site imitation; ensured regulatory documents, contracts, IRB approvals for informed consents, and site binders on site.
- Managed clinical device studies with 112 sites and 1500 patients
- Promoted to Clinical Research Associate 1 within six months of employment.
- Review and edited Case Report Forms
- Edit of study protocols
- Negotiated site contracts and budgets
- Reviewed and edited informed consents
0-5 years of experience
Monitored all site visits including pre-study, initiation, interim, and close-out visits.
- Identified and selected physicians to perform clinical trials.
- Maintained working knowledge of all applicable FDA regulations and ensure compliance with current FDA
- Regularly performed Investigator Product Accountability during monitoring visits.
- Collected, reviewed, approved, and submit all regulatory documents for assigned clinical sites.
- Accurately reported AEs/SAEs and protocol violations within a timely manner.
- Reviewed and ensured compliance with CRFs and source documentation.
0-5 years of experience
Performed initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Performed monitoring visits and site management for assigned sites.
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalated quality issues to CTL and/or line manager.
0-5 years of experience
Collected and organized data from patients collected during clinical research trials
- Coordinated and processed results gained from long-term usage and testing of medical drugs, products and other medical procedures relating to the clinical research
- Ensured clinical trials stayed on track with the trial objective and complied with federal regulations
- Monitored patient cases and explained proper procedures for clinical testing and used reference material as an additional aide
- Maintained database of patients information
- Analyzed data collected from patients during the clinical research trial
0-5 years of experience
Reviewed clinical trial protocols and developed study documents in accordance with Federal
Regulations.
- Conducted site initiation, interim, and closeout monitoring visits to confirm compliance with the protocol, International Conference on Harmonization guidelines, Good Clinical Practice, and
- Identified site issues and initiated corrective action plans.
- Verified data in source documents were in agreement with case report forms and initiated data
- Ensured all Adverse and Serious Adverse Events were properly documented and reported per
- Acted as primary liaison between Sponsor companies and clinical investigators throughout a
6-10 years of experience
Developed and negotiated Clinical Trial Budgets and Clinical Trial Agreements with investigators.
- Assisted in generation of Master Clinical Trial Agreements with Universities and Institutions.
- Ensured accurate and complete accountability of trial medication.
- Produced Active Study Progress Reports, monthly site status and enrollment tracking utilizing IMPACT and WinFx.
- Screened potential investigators, conducted study initiations and close outs.
- Ensured complete and follow-up of Regulatory Documentation and Serious Adverse Event reporting was complete, accurate and reported to the company, IRB and FDA.
- Trained new employees, trial coordinators and investigators regularly to instill the Novartis SOPs, and Working Practices with regard to CQA and GCP guidelines.
- Presented at group meetings and protocol initiation meetings on various areas of clinical research.
0-5 years of experience
Assisted in the development and review of study case reports, informed consents, source documents, study reference manuals and monitored plans according to clinical protocols.
- Assisted with identification, screening, and qualification of investigators and study sites.
- Performed site initiation, subject recruiting and routine monitoring.
- Assisted with overseeing study activities, collecting data, statistical reports and analysis.
- Conveyed project information and troubleshooting, advised, and followed up on study progress.
- Coordinated study evaluation meetings and project meetings providing team with updates of each site activity.
0-5 years of experience
Monitored (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance.
- Recruited investigators for participation in clinical trials.
- Obtained, reviewed for appropriateness, and processed regulatory and administrative document from investigator sites.
- Developed CRFs for clinical trials. Reviewed and verified CRFs and other clinical data, in-house, for completeness and accuracy. Generated and resolved queries of CRF data with study site personnel.
- Prepared and processed SAE reports.
- Reviewed tables and listings generated from study data.
- Reviewed draft protocols for completeness and feasibility.
- Prepared project management reports for clients, project personnel and management. Assisted in writing clinical study reports, with supervision.
0-5 years of experience
Monitored Phase II-IV Studies on Interferon Alpha in Oncology, Hepatitis C, HIV and Infectious disease.
- Data collection and overview of all aspects of the trial.
- On-site monitoring for all visits from initiation to close-out.
- Assisted in development and implementation of clinical trials, coordinate assigned clinical trials and ensured compliance with GCP/ICH guidelines.
- Developed and implemented clinical monitoring programs.
- Assisted in clinical site selection, qualification, and initiation process.
- Conducted review and source verification of clinical data and ensured resolution of data queries or non-conformances.
- Provided updates on clinical trial progress/results.
0-5 years of experience
Responsible for attending project-specific training as well as meetings per clinical trial needs
- Conduct pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP (60-80 % travel); Primarily conducted co-monitoring visits
- Responsible for overall site management for assigned sites, including written and verbal communication and scheduling of monitoring visits
- Performed source data verification, drug accountability, and reviewed regulatory documents during site visits
- Responsible for completion of visit reports and maintenance of study-related databases
- Performed other duties as requested by management
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[Clinical Research Associate]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
