SUCHITRA ROUT
South Brunswick,NJ
Summary
Organized and detail-oriented clinical research professional seeking a challenging position in a dynamic firm that gives opportunity for continues learning and provides application of knowledge and skills that can be align to the latest trends, and be part of a team that dynamically works towards the growth of the organization and myself. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Operation Specialist
Syneos Health
12.2021 - Current
- Provide operational support for Clinical Operations team with heavy focus on study start-up activities, maintenance and study closure deliverables
- Collaborate with the Clinical Trial Managers (CTMs) and clinical study team in execution of clinical trial for all phases of study conduct (start up, conduct/maintenance & closeout)
- Assists Clinical Trial Manager with site management activities, including serving as Sponsor representative for sites on assigned studies, and communicating with sites
- Participate in creation and distribution of study materials, including essential documents, presentations and reports
- Communicate directly with sites to drive collection of essential documents from start-up through study closure
- Responsible for on-going management of electronic Trial Master File (eTMF) for assigned studies
- This is inclusive of receipt, review, QC, tracking & filing of all documents required within the conduct of the study
- Responsible for collection, review and approval of regulatory documents including FDA 1572’s, CV’s, FDF’s, Protocol Signature Pages and lab accreditations and ensure all documents are up to date and audit readiness
- Oversee the management of the eTMF for multiple studies & review study files/TMF periodically for accuracy, completeness and inspection readiness
- Prepare TMF health reports and collect TMF status update and TMF metrics
- Perform quality check of documents prior to eTMF submission and resolve QC findings in eTMF
- Prepare and maintain site related study trackers
- Accurately update and maintain CTMS & update Expected Documents List (EDL) in eTMF
- Perform continuous essential document reconciliation through out lifecycle of study
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies or project team
- Manages, processes site requests and routes correspondence appropriately
- Provide regular study updates to appropriate internal stakeholders
- Assist with guiding and mentoring newly hired CTA.
Clinical Research Coordinator
Eurofins | CRL
10.2020 - 12.2021
- Acted as project manger on studies including photoallergy and phototoxicity using SOPs, GCP and ICH guidelines as directed by department manager
- Conduct clinical trials as specified in study protocol under supervision of principal investigator
- Review approved protocol, informed consent forms and assist in preparation of test articles
- Create, prepare and setting up source documents, Trial Masterfile, medication history and other study related materials
- Contact, screen and recruit subjects in conformance with requirements specified in study protocol and schedule subjects’ visits to clinic
- Provide professional experience to potential subjects by presenting informed consent form discussing consent and study with them and answering all inquiries
- Documenting and filling signed informed consent forms, medical history and questionnaires appropriately to ensure all required data gathered and recorded in appropriate source documents
- Record observations, test results and physical measurements
- Maintain and update research records, case report forms and source documents for clinical trial
- Complete and maintain adverse event form, serious adverse event forms for clinical trial
- Ensure trial master files are complete, current and filed correctly
- Record and maintain study supply as necessary
- Manage payments to study subjects and complete study closeout activities at end of study
- Adhere to all Standard Operating Procedure to ensure consistency and quality work.
Recruitment Scheduler
Accenture Services Pvt. Ltd
12.2009 - 01.2012
- Establishing recruiting requirements by learning organization plans and objectives; meeting with managers to discuss requirements
- Worked as Full cycle recruiter, sourcing, screening, interviewing, scheduling technical round interview of matching profiles for ITES requirements from different job portals for entry level to higher level to meet business requirement
- Worked as liaison between hiring manager and potential candidates
- Keep track of profile movement in pipeline till candidates get on-boarded
- Delivered exceptional level of service to each candidate by listening to concerns and answering questions
- Dispatch offers letters for offer accepted candidates
- Issue hard copy of offer letters highlighting salary package, job designation and joining date.
Education
Certification -
University of California, Irvine, Division of Continuing Education
Irvine, CA04.2022
Post Graduate Diploma in Management - Human Resources
IFIM Business School
Bangalore, India07.2010
Bachelor Degree in Tourism and Hospitality Services - Tourism and Hospitality
IIHMC
Bhubaneswar, India07.2010
Skills
- Good Clinical Practice
- Veeva Vault
- CTMS
- ETMF
- Shared Investigator Platform (SIP)
- Trial Management
- Electronic Data Capture
- Documentation and Reporting
Certification
Good Clinical Practice, The National Institute on Drug Abuse (NIDA), 07/2021, 07/2024
Timeline
Clinical Operation Specialist
Syneos Health
12.2021 - Current
Clinical Research Coordinator
Eurofins | CRL
10.2020 - 12.2021
Recruitment Scheduler
Accenture Services Pvt. Ltd
12.2009 - 01.2012
Certification -
University of California, Irvine, Division of Continuing Education
Post Graduate Diploma in Management - Human Resources
IFIM Business School
Bachelor Degree in Tourism and Hospitality Services - Tourism and Hospitality
IIHMC
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