clinical research associate

• Contracted position to assist in the re-audit and immediate correction of local and international site citations following a negative FDA audit.
• Ensured the timely accurate and complete collection and submission of study data.
• Prepared Monitoring reports.
• Ensured compliance to regulatory requirements.
• Identified, address, and resolve issues and problems as they might occur.
• Ensured collection of all data and remaining study supplies for return to the Sponsor/CRO
• Ensured that appropriate study documents are complete and properly filed

clinical research associate

• Successfully conducted the listed site visits as required by client/study — PreStudy Site Selection, Site Initiation, Interim Monitoring, Site Close out.
• Ensured all relevant studies follow ICH-GCP, Scheduled-Y, Applicable SOPs and local regulations
• Met with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team
• Confirmed the appropriateness of the site for the study in all aspects and ensure that all documentation required to initiate the study is complete
• Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO SOPs
• Identified Principal Investigator based in their capabilities.
• Performed  site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable

clinical research associate

• Responsible for collecting experimental data 
• Perform venipuncture; collecting, preparing and storing blood samples
• Knowledge of infection control procedures, quality assurance support and data entry and retrieval
• Perform ECGs, blood pressure, vitals
• Collaborates with medical professionals to report changes in subjects’ conditions

clinical research associate / auditor

• Create and update project plans and timelines. 
• Review of miscellaneous project-specific documents, review of technical translations;
• Performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor. 
• Сommunication with investigational sites, with vendors and supporting services, interaction with internal workgroups to evaluate needs, resources and timelines; 
• Collection essential document and review for site start-up and initiates in compliance with project specifications and applicable SOPs with adherence to EU / Ukrainian Regulations, ICH/GCP guidelines and good documentation practices. 
• Personnel Management. Writing, developing and improving SOPs. Preparation of a package of documents to regulatory authorities and local ethical committees.
• Submission of reports to regulators. 

clinical research associate

• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files. Processed specimens for clinical trials, sample storage and assay.
• Archives the clinical data files.
• Met with clinical study sponsor representatives to discuss study details.
• Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures(SOPs), good clinical practice(GCPs) and local requirements.

clinical research associate

• Monitored the collection,accuracy and integrity of regulatory documents in site binder.
• Preparation of PART-A and PART-B files.
• Monitored progress throughout the duration of the file.
• Worked closely and effectively with other department personnel to communicate pertinent information and maintain study conduct.
• Worked closely with data management and site teams to resolve discrepancies.
• Established drug trail methodologies and procedures.
• Submitted routine CRF’s and follow-up letters.

clinical research associate

• Handling multiple sites during selection, initiation, ongoing and closure phases of the clinical trials. Well versed in various monitoring functions like trial product handling,source verification, SAE reporting, handling of temperature deviations and maintenance of the trial master files.
• Interaction and communication with key stakeholders, organizing and conducting several investigator meetings and ensuring sites are  compliant to requirements and guidelines of regulatory authorities. 
• Budgeting of new clinical trial.
• Preparation of submission of documents for Health Authority and ethics committee for multiple clinical trials.
• Localisation and translation of trial documents.
• Processing of invoices and negotiations with vendors
• Organisation of investigator meetings.

senior clinical research associate

•  Acute Myeloid Leukemia (Phase 3) 
• Chronic Lymphocytic Leukemia (Phase III) 
• Diffuse Large B‑Cell Lymphoma (Phase III)  
• Audit preparation, assistance, query resolution and follow-up.

sr. clinical research associate

• Conducting  pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP;
• Site management for assigned sites including written and verbal communication and scheduling of monitoring visits; 
• Preparation of visit reports and maintenance of study-related databases;
• Taking over Lead CRA responsibilities on a project, acting as the primary contact for all monitoring- related questions for the monitoring team;
• Facilitating training for new CRAs. 

clinical research associate

• Participating in the site selection process, feasibility assessment; 
• Performing all types of study site monitoring visits;
• CRF review and source data verification; 
• Preparation for study submission to the regulatory authorities; 
• Site management; visit reporting; 
• S/AE processing, reporting and follow-up; 
• Ensuring on-site compliance with national regulations, GCP, protocol and procedures; 

clinical research associate (oncology)

• Ensured safe and right conduct of clinical trials according to ICH-GCP guidelines. Maintained understanding of PPD’s SOP (standard operating procedures) and also required PPD SOPs Provided clinical study progress reports to Clinical Trial Manager periodically. 
• Planned & conducted pre-study site evaluation visits with Sr. Clinical Research Associates / Clinical Trial Monitor. Conducted clinical site feasibility and also help CTMs in study feasibility. Prepared and maintained Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents.
• Prepared EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation. Attended and assisted with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
• Planned & executed SIV (site initiation visit) with Sr. Clinical Research Associate/CTM. During site initiation visit (SIV) my responsibilities were meeting with clinical investigators (PI) and their teams to make sure that all aspects of the study were understood by the principal investigator and his/her staff, validated the suitability of the EC/IRB & to ensure that all records required for the study were completed.
• Managed the clinical central laboratory in regard to issues of site. Planned, conducted site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee. Closely kept track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development. Assessed the subjects (patients) for study protocol compliance though SDV (source data verification). Monitored patient Informed Consent progression for clinical study. Examined on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
• Identified discrepancies in the case report forms against the source documents occasionally, resolved them and after that took away the CRFs. Followed up with clinical site for resolution of DCFs or any queries. Ensured that adverse event/serious adverse event AE/SAE were reported and followed up with the concern departments. 
• Assessed appropriate Investigational Product (IP) answerability at site. Planned and conducted site close out visits (SCV) and made sure that collection of all clinical study data was completed. Prepared the applicable site visit reports and follow up letters. Subsequent to study completion, ensured that investigational products (IP) of the study were returned to the PPD.

clinical research associate

• Conduct research to develop methodologies, instrumentation, and procedures for medical application, analyzing data and presenting findings to the scientific audience and general public.
• Write and publish articles in scientific journals.
• Consult with and advise physicians, educators, researchers, and others regarding medical applications of physics, biology, and chemistry.
• Teach principles of medicine and medical and laboratory procedures to physicians, residents, students, and technicians.
• Design research studies in collaboration with physicians, life scientists, or other professionals.
• Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.
• Collaborate with others in the organization to ensure successful implementation of chosen problem solutions.

clinical research associate

• Responsible for the detailed processes of recruitment, including consenting, application of medical device, and collection of data.
•  Ensure integration of device  with EEG, other respiratory, cardiac and additional biological data collected during in-patient period and to make data set available to research team.
•  Enter data into relevant databases and prepare cohorts for in-house studies.
•  Undertake statistical analysis of data. 
• Maintain accurate and complete records and ensure data security and confidentiality of medical data. 
• Ensure the highest standard of record keeping, maintaining