Senior Clinical Research Associate resume example with 9+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
Professional Summary
Senior Clinical Research Associate with over 6 years of experience as a knowledgable resource to help other CRAs develop their skills. Providing expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and monitors specified sites to ensure quality and integrity of data, compliance with the client’s standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.
Skills
6+ years of clinical monitoring experience.
Experience working in phases I, II and III clinical trials.
Sound knowledge of medical terminology.
Excellent written and verbal communication skills.
Good analytical and problem solving skills.
Detail-oriented and ability to multi-task.
Ability to work independently and work with a matrix team environment.
Ability to perform up to 80% of nationwide travel.
Work History
Senior Clinical Research Associate , 02/2019 to Current Abbott Laboratories – Ridgefield Park, NJ,
Assists in the selection of investigators through conduct of pre-study visits to evaluate the capability of the site to successfully conduct the clinical trial.
Ensures all regulatory documentation has been obtained prior to initiating the clinical study.
Conducts Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close-out Visits (COVs), as assigned, and works with the sites to have them audit-ready at all times.
Monitors all aspects of a clinical trial from pre-study visits through the close-out visits to ensure study requirements are met and sites are compliant with the protocol, product requirements, and regulatory obligations in accordance with FDA, ICH GCPs, local regulatory requirements and corporate SOPs.
Ensures timely and efficient execution of clinical trials and that sites are audit-ready at all times.
Assists in team meetings with other CRAs and meeting with site staff.
Prepares status and monitoring visit reports.
Works with new CRAs to help train them and assist with training other internal research support staff on the studies assigned.
Trains investigators, coordinators and other site personnel on data collection methods, the protocol requirements and study specific assessments.
Assists in the planning and preparation of investigator meetings, and present information and training at the meetings.
Reviews and verifies the accuracy of the data on-site or remotely, and initiate action to resolve issues identified.
Participates in in-house review of listings and generate queries after this remote monitoring.
Performs medical and data quality review checks.
Reviews Adverse Event (AE) incidence, both serious and non-serious.
Ensures clinical supplies are properly stored and accounted for, and any necessary blinding is maintained.
Confirms the IC process is completed and documented appropriately, and patient safety and confidentiality is maintained.
Assesses Investigational Product (IP) accountability, dispensation and compliance at the sites.
Clinical Research Associate II, 01/2017 to 02/2019 Bio-Rad Laboratories – Raleigh, NC,
Worked closely with Clinical Program Managers and Clinical Project Managers to execute the successful conduct of assigned studies consistent with the processes, procedures, clinical strategy, project plans, and protocol.
Worked with representatives from key functional groups including Medical Affairs, Sales, Quality, Regulatory Affairs and European Clinical Group to maintain site relationships.
Worked closely with Contract Research Organization monitors to ensure patient safety and integrity of data.
Prepared study related material and training materials.
Performed site qualification and facilitated training of investigators and site staff.
Worked with Project Manager to develop Monitoring Study Plans and Monitoring Tools.
Conducted periodic monitoring activities with investigative sites, including (but not limited to) reviewing case report forms (CRFs); performing source document verification; identifying AEs, SAEs and protocol deviations; reviewing device accountability; ensuring compliance with good clinical practice (GCP) guidelines, IQVIA SOPs and FDA regulations; reviewing findings with Investigator.
Conducted site initiation and study closeout activities.
Prepared, modified and distributed study materials such as CRFs, study reference manuals and monitoring guidelines/manuals.
Collected and maintain required regulatory documentation from clinical investigative sites.
Ensured compliance with protocol and overall clinical objectives.
Clinical Research Associate I, 06/2014 to 01/2017 Cedars Sinai – Anaheim, CA,
Monitored clinical study sites and investigator performance and documented activities.
Ensured investigator compliance with the clinical study protocols and informed consent process.
Point of contact for investigators and study site team to ensure relevant study information is communicated.
Ensured that laboratory specimens were being collected and shipped per protocol.
Reconciled receipt of laboratory specimens with corresponding Case Report Forms.
Ensured that generated data queries were resolved by the clinical study sites in a timely fashion.
Performed PSSVs, SIVs, IMV, and COVs on an as needed basis per protocol and study monitoring plan.
CRC, 01/2012 to 06/2014 Md Anderson – City, STATE,
Led [Type] team in delivery of [Type] project requiring close cooperation among members to share information and develop solutions to meet broad array of deliverables.
Education
Bachelor of Science: Accounting, Expected in Anambra State University - Anambra, Nigeria , GPA:
Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.