Multi-talented clinical research professional proficient in handling patient information, laboratory samples and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills.
Skills
Materials inspection
Correction action planning
Quality Assurance
Problem-solving skills
Sampling procedures
Safety procedures
Product inspections
Testing protocols
Correction plans
Experience
Quality Assurance Specialist I, 10/2021 to Current Cambridge Isotope Laboratories, Inc. – Tewksbury, MA,
Collaborated with management to discuss effective plans for resolving major quality problems.
Assure compliance with sponsor/CRO protocol, applicable federal, state and local regulations as well as policies to avoid any business interruptions,
Communicates all identified compliance nd quality risks/issues to QA manager. Responsibilities include protocol risk assessment, plan and conduct QA audits, implement CAPA processes when necessary;
Work with QA manger to implement and monitor processes that ensure quality when adding new sponsors, sites, and studies;
Perform QA audits to assess whether records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, CTT standard operating procedures (SOPs), protocols, and corporate policies, and implement CAPA processes as appropriate. Identify , and document and report derivations from regulations, protocols, and CTT SOPs to the QA Manager;
Maintain written records of all audits performed as required by team leads, study coordinators, department managers, Site director, and assistant site director;
meet regulatory with QA manager, site director and assistant site director to review any trends or issues at the site;
Participate in preparation and review of study and regulatory files in preparation for sponsor site visits and regulatory inspections;
Assure that study files are well maintained, organize and complete;
Participate in collecting and reporting of quality metrics;
stay abreast of all federal regulations and ICG Guidelines and CRR policy changes;
Assist in ensuring that all CTT employees have adequate training (protocol specific/non-protocol specific) and training documentation to perform duties assigned;
Clinical Research Coordinator, 12/2019 to 10/2021 University Of California – Irvine, CA,
Read, understand and is able to accomplish protocol specified patient visits and procedure;
Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs;
Obtain patient informed consent according to federal regulations, GCPs and IRB requirements;
Is creative and diligent in recruiting qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines;
Complete all required training in a timely manner;
Schedule and conduct patient visits according to protocol requirements and timelines;
Maintain accurate and complete written source documentation of patient visits and protocol related activities;
Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the sponsor;
Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with CTT, between CTT and sponsors, and between CTT and other entities, as well as HIPAA regulations;
Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary;
Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to supervisor, Principal Investigator and/or Sub-Investigator;
Account for clinical trial materials (i.e. CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study;
Maintain ongoing communication with President, Principal Investigator, Sub-Investigators, and other persons assisting with the trial and documents these communications according to protocol requirements and CTT policies;
Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and CTT policies;
Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research;
Attend Investigator Meetings and/or other trainings as directed;
Quality Control Coordinator, 08/2017 to 12/2019 Cushman & Wakefield Inc – Dayton, OH,
Represent CTT in a professional and courteous manner (verbal, written and in appearance) when interacting with CTT staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physician’s offices;
Conduct a thorough and precise review of study charts utilizing CTT SOPs and sponsor protocols. Indicate data points that are missing or discrepant and identify and report any trends to the QC Data Manager;
Accurately enter data into an eCRF/CRF system according to the sponsor provided eCRF/CRF guidelines in a timely manner;
Identify and report missing data points or inconsistencies to the clinical research coordinator and QC Data Manager as soon as possible;
Source document creation;
Attend SIV meetings;
Report any discrepancies between the source and CRF/eCRF immediately to the CRC and the QC Data Manager;
Resolve open queries thoroughly, accurately and in a timely manner;
Assist in sponsor monitor visits to resolve queries in a timely manner;
Posses the ability to work closely with other staff members and sponsor representatives in a professional manner;
Perform all duties in a time- and cost-effective manner;
Clinical Research Coordinator, 08/2014 to 08/2017 University Of California – Berkeley, CA,
Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
Obtained informed consent of research subjects or guardians
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Kept patient care protocols and clinical trial operations in compliance.
Collected, processed and delivered specimens from trial participants.
Checked electronic data capturing systems for integrity and compliance.
Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Performed pre-study, closeout and interim visits to check on study activities.
Assessed drug storage conditions and procedures to check adherence to standard protocols.
Tracked study-specific trial management tools and systems;
Attend Investigator meetings
Education and Training
High School Diploma: , Expected in 06/2010 John Marshall High School - San Antonio, TX, GPA:
Associate of Applied Science: , Expected in 08/2014 Northwest Vista College - San Antonio, TX GPA:
Certifications
Fibroscan Certified- Echosens- Jun 2020
Transportation of Dangerous Goods (IATA), Mayo Clinic, Mayo medical Laboratories- Jan 2020
Cardiopulmonary Resuscitation (CPR) AmJessican Heart Association- Nov 2019
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