SHUBHANGI WAGHMARE
Clinical Resrach Associate
New Panvel
Summary
- Knowledgeable Clinical Research Associate professional with 5 years of experience in Clinical Trials.
- Experienced in organising, coordinating and overseeing clinical trials. excellent communication and interpersonal skills.
- Meets job demands and deadlines through diligent work-ethic and dedication to quality.
Overview
6
6
years of professional experience
7
7
years of post-secondary education
3
3
Languages
Work History
Clinical Research Associate
DiagnoSearch LifeSciences Pvt Ltd
11.2022 - Current
- Responsible to coordinate the implementation of clinical trial protocol and documentation st the assigned sites in accordance with GCP, company/sponsor SOPs(as applicable) and applicable regulatory requirements.
- Coordinate with the sites to procure documentations required for regulatory submissions.
- Review source document and verify against the case report forms (CRFs) for completeness,accuracy and compliance.
- Maintaining all the study & site-specific documentations on eTMF.
- Coached, guided and supported investigators and site staff to maintain progress towards study objectives.
- Progressed projects to deadlines by monitoring submissions, managing recruitment and confirming case report form completion.
- Identified, evaluated and set up well-equipped trial sites, performing thorough closing processes upon trial completion.
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
04.2021 - 11.2022
- Contribute to the identification of new sites for clinical trials; analyze site capability and performing site feasibility for assigned study
- Performing Site Selection Visits for assigned study as per the Protocol, Macleods SOPʼs, ICH-GCP and regulatory requirements and prepare site selection visit report
- Facilitate the preparation and collection of study and site level documents
- Customization of site specific documents and study tools
- Preparing site and tracking of all the activities for site initiation and to ensure that all necessary site tools are circulated to sites
- Collaborate with PM/CTL and CTA to communicate trial logistics prior to SIV
- Performing Site Initiation Visits, Site Monitoring Visits, Close-out visits for assigned study as per the Protocol
- Ensure smooth operational execution of allocated clinical trials and proper follow up with the sites for all activities
- Ensure AE and SAE are reported as per protocol Macleods SOP, GCP and Regulatory requirements
- Review study site data; resolve discrepancies observed on a continuous basis in order to achieve timely study completion
- Participate in internal team meetings and provides inputs and updates on regular basis
- Updating all the study trackers for updates in timely manners and provide any data as per requirement
- Follow up with sites for study updates and action items on regular basis
- Assess the site organization on regular basis in order to secure the quality and support the site
- Prepare the study files (TMF, SMF and ISF) and review and update them on an ongoing basis as per study requirements
- Reconciliation, Management and Tracking of IP and other clinical trial supplies
- Provide inputs in protocols and study documents, monitoring strategies and planning of the trial activities.
Clinical Trial Assistant
Macleods Pharmaceuticals Ltd
10.2018 - 04.2021
- Establish and maintain the tracking tools for assigned trials
- Receive clinical study documents from study team, review for completion, accuracy & expiration, and filling the same in study file
- Preparation of dossier for EC submission and sending the required documents to the sites
- Prepare the study files (TMF, SMF and ISF) and sending the ISF to the respective sites along with the all required documents
- Review TMF and SMF inventory for missing and expiring documents on an ongoing basis as per study requirements
- Support maintenance of the Trial Master File (TMF) & Site Master File (SMF) and assist in quality control as appropriate
- Support Clinical Trial manager and CRA to track and file documents and study metrics
- Review and assist in the collection of essential documents for completeness and compliance with the protocol and appropriate regulations
- Distribute clinical trial related materials to sites or clinical trial team members
- Participate in team meetings and assist in tracking of action items
- Assist CRAs in preparation for clinical trial site monitoring visits
- Assist in the creation of study materials, including but not limited to documents, presentations, and reports
- Perform administrative tasks to support Clinical Trial Department and team members as needed.
Research Associate
1 Lotus Market Research Company
04.2021 - 09.2021
- Conducting qualitative or quantitative surveys, which may involve fields, interview or focus group assessment
- Monitoring the progress of research project
- Analyzing and interpreting data to identify patterns and solutions, including surveys and focus group transcripts
- Meeting and liaising with clients to negotiate and agree research project
- Formulating Plans for Proposals to present to your client or senior management
- Writing and managing the distribution of surveys and questionnaires
- Moderating focus groups.
Education
Bachelor in Pharmacy -
NCRD's Sterling Institute of Pharmacy
01.2014 - 04.2018
undefined
Diploma in Pharmacy - undefined
JSPMʼs Jaywantrao Sawant Institute of Pharmacy
01.2012 - 04.2014
Skills
Accomplishments
- Participated In NCC (2009) Attended ATC Camp 8 MAHARASHTRA GIRLS BN NCC Held at Uran J.N.P.T. (May 2008).
- Participated In Adventure Camp & Fort Cleaning Camp Held at Raireshwar Fort Bhor, Pune(2012)
- Participated As Volunteer in Pulse Polio Immunization Program Held By Cantonment Board, Dehu Road from 25/2/13 to 27/3/13.
Hobbies
- Travel
- Reading
- Music
Timeline
Clinical Research Associate
DiagnoSearch LifeSciences Pvt Ltd
11.2022 - Current
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
04.2021 - 11.2022
Research Associate
1 Lotus Market Research Company
04.2021 - 09.2021
Clinical Trial Assistant
Macleods Pharmaceuticals Ltd
10.2018 - 04.2021
Bachelor in Pharmacy -
NCRD's Sterling Institute of Pharmacy
01.2014 - 04.2018
Diploma in Pharmacy - undefined
JSPMʼs Jaywantrao Sawant Institute of Pharmacy
01.2012 - 04.2014
undefined
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