Anastasiya D.

Experience

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  New Jersey Orthopaedic and Sports Medicine, LLC

  May 2014 - Dec 2014

  Clinical Specialist

  ● Obtained medical history and conducted physical examination ● Assist physiatrist with ultrasound and fluoroscopic guidance for articular and epidural injections● Complete musculoskeletal physical examination for physiological ailments● Practice sterility techniques and field set up during surgical procedures

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  Manhattan Dermatology & Cosmetic Surgery

  Dec 2015 - Jul 2017

  Clinical and surgical specialist

  ● Complete physical evaluations and assessments● Appropriately document initial presentation and clinical history as well as follow up visitations● Assisted with procedures and performed basics laboratory tests ● Assisted with superficial surgical resections of the skin ● Facilitate insurance authorizations and determination of benefits of coverage for procedures, visits, and/or medication coverage

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  Mount Sinai Health System

  Jul 2017 - Apr 2018

  Assistant Clinical research coordinator

  ● Provided assistance in specific tasks relating to the preparation of both on-going and new in Ulcerative colitis and Crohn disease trials ● Assisted with required regulatory submissions (e.g. preparation of essential study documentation from start-up through conduct of study) ● Maintenance of study drug accountability processes (e.g. maintains drug logs, temperature logs, assist in dispensing / retrieving study drug from the subjects)● Actively monitored all the subject visit related activities, and ensuring clinical assessments and subject data are within protocol guidelines● Assisted with monitoring and audit visits, clarification of subject data, and query resolutions● Assisted in writing up abstracts for scientific conferences Show less

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  Premier Urology Group

  Apr 2018 - May 2019

  Clinical Research Coordinator

  ● Administratively and clinically manage an average of six clinical trials (10 months of serving as primary coordinator in bladder cancer and prostate cancer trials; overactive bladder trials and benign prostatic hyperplasia trials) with the scope of the established study protocol, while adhering to all human subject regulations as defined by IRB and the federal mandates pertaining to human subject research● Managing feasibility assessments, study start up and closeout activities and regulatory submissions required by the sponsor ● Prepare case report form (CRFs), establish and organize study files in regulatory binder● Coordinating patient enrollment through developing relationship with physicians and patients, determining subject eligibility based on understanding of protocol and research goals, and monitoring all aspects of study subject recruitment, including reaching out to research participants for data and bio-specimen collections● Efficiently tracking and monitoring mechanisms for the recruitment of new and established patients. Assuring high levels of study subject involvement and developing mechanisms for efficient, ongoing recruitment of key study subjects● Discuss study protocols with patients and verify the informed consent documentation; provide patient with written communication of their participation● Responsible for documentation and transmission of study data (EDC and IWRS). Monitoring follow up and retention procedures for subjects, assisting with computerized gathering, collection and coding of accurately documented and completed in timely manner data ● Performing clinical assessments to support protocol requirements ● Establish relationship with offsite partners to retrieve and process specimen and data ● Attended weekly meetings related to ongoing research protocols and assisting in generating monthly reports of subject activities and study progress Show less

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  Integrative Clinical Trials, LLC

  May 2019 - Dec 2020

  Senior clinical research site associate

  • Administratively and clinically manage an average of twenty clinical trials serving as a lead clinical research associate • Managing Phase II-IV investigator and sponsor initiated trials with concentration in central nervous system and general medicine • Managing feasibility assessments, budget negotiations and contract review• Adhering to GCP, ICH, HIPAA, NIH, FDA Regulations, SOPs and maintaining ongoing regulatory submission required by sponsor • Addressing PSV, SIV, IMV, closeout visits and its main objectives • Responsible for developing and maintaining site’s source documents to match CRF • Develop patient recruitment strategies to meet enrollment timelines • Establishing rapport with sponsor representatives and maintaining frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the pati;ents, doctors, pharmaceutical sponsors and all levels of the company• Assuring that key personnel engaged in research project have met training requirements in accordance with federal regulations• Provide training and guidance to junior clinical research coordinators• Performing clinical assessments to support protocol requirements, resolving EDC queries, managing IP accountability • Administering psychiatric rating scales to determine accurate diagnosis of psychiatric disorders• Managing onsite research protocol activities and ensure organization of study protocol procedures and good clinical practices Show less

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  IQVIA

  Dec 2020 - now

  Lead Clinical Research Associate

  •Performing site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines•Administering protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues•Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations•Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution•Ensuring copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements•Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation•Collaborating and liaising with study team members for project execution support•Accountable for supporting development of project subject recruitment plan on a per site basis•Provide one-on-one mentoring and group mentoring to clinical research associates as well as supporting with onboarding training and activities Show less