Clinical Research Management
Resume:
RAMYA KRISHNA CHUNDURU
Salt Lake City, Utah *****
****************@*****.***
Objective:
To further my career by obtaining a position utilizing my experience and education.
Professional Experience:
Regulatory Coordinator
September 2017 – Present
University of Utah, Salt Lake City
Department of Pediatrics
Develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements.
Supports the Principal Investigator and study team(s) ensuring compliance with all University, State and federal regulations that govern clinical research.
Prepares applicable submission forms and submits updated documents to the IRB including but not limited to: Amendments, Addendums, Investigator’s Brochure, Safety Information, Form FDA 1572s and informed consent documents.
Maintains and accurately files all necessary logs within the regulatory binder(s).
Expertise with regulatory procedures, HIPAA compliance, and Federal and local regulations for research on human subjects.
Supports all aspects of regulatory compliance.
Prepares, facilitates, submits and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy.
Facilitates and coordinates all aspects of IRB submissions. Include evaluating the protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol.
Prepares regulatory documents, including consent forms for submission to research review committees.
Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
Clinical Research Coordinator and Regulatory Study Coordinator July 2016 – September 2017
Centex Studies, Inc. Houston, TX
Manage and Coordinate multiple clinical trials from inception to completion for a reputed SMO.
Act as a liaison and develop relationships with sponsors and CRO to deliver timely reports and accurate data.
Maintain regulatory binders for all studies to ensure SMO adherence to FDA Regulations and ICH/GCP Guidelines.
Study start up document submission to sponsors/CRO
Oversee all site initiation visits, monitoring visits and close out visits with CRO/Sponsor
Manage all IRB correspondence and submit ongoing review and close out reports
Oversee SMO recruiting and enrollment goals and allocate finances for advertising
Review Clinical Trial progress and adjust project timelines accordingly.
Submit weekly reports to President of SMO and sponsors/CRO’s on project progress and other relevant issues.
Schedule and oversee weekly meetings with staff members
Develop business relationships with Doctors, Nurse practitioners interested in research to generate new business for SMO
Implement protocol specific and GCP training programs for staff members and clinical staff
Manage, monitor and oversee four study coordinators to ensure protocol adherence, timely data entry and query resolution.
Prepare trial specific source documents, study and research documents
Monitor in-house data management operations and implement clinical study procedures and strategies
Identify, interview and manage qualified staff for each trial.
Ensure Adverse Events and SAE are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
Establish in-house auditing procedures to ensure clean, FDA ready research charts and database.
Regulatory Specialist responsible for all regulatory aspects of three sites in a reputed SMO
Maintaining regulatory binders for all studies to ensure SMO adherence to FDA Regulations and ICH/GCP Guidelines.
Reporting, monitoring, distributing and maintaining files for all safety information including Investigational Drug Brochures, IND safety reports and Serious Adverse Events (SAE) reports.
Updating Clinical Trials Management System (CTMS) as needed with location profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information.
Preparing regulatory documentation and ensuring all necessary forms are submitted to Sponsor Company to activate protocols.
Distributing and tracking financial disclosure forms, protocol signature pages and FDA 1572 Forms to obtain local investigator signatures.
Tracking expirations and retrieves current documentation for medical licensures, CVs and laboratory accreditations.
Posting regulatory documents including protocols, amendments, consent forms, SAE forms etc. on the CTMS.
Preparing, maintaining, updating and auditing study specific regulatory files, IRB files and location profile filing system per FDA guidelines and resolving queries as necessary.
Distributes IRB documentation to study sponsors, research and clinical staff.
Ensures all regulatory files are prepared for off-site storage in accordance with FDA and other applicable regulatory guidelines.
Communicating verbally and in e-mails effectively with company’s coordinators, recruiting staff, management; sponsors, monitors; IRBs; and other team members.
Prepare and oversee all regulatory aspects site initiation visits, monitoring visits and close out visits with CRO/Sponsor
Manage all IRB correspondence and submit ongoing review and close out reports.
Clinical Trial Adminstrator
June 2012 – August 2014
Biological E Ltd. Hyderabad, India
Ensuring compliance with company SOP’s and processes.
Participating and training on inspection readiness.
Monitoring Trial Master File (TMF) compliance.
Supporting preparation of documentation required for regulatory agency inspection and internal audits.
Overseeing set – up and consolidation of outsourced elements of the TMF with preferred CRO vendors.
Performing periodic quality assessments of clinical TMF documents where required, with support from the Clinical Document Management Team.
Contributing to assigned Clinical Document initiatives.
Creating the TMF structure according to the study – specific TMF Roadmap.
Implementing a consistent process for Clinical Document Management QC of incoming TMF documents.
Supporting inspection readiness.
Overseeing Quality content check and document completeness QC.
Develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements.
Supports the Principal Investigator and study teams ensuring compliance with all University, state and federal regulations that govern clinical research.
Prepares applicable submission forms and submits updated documents to the IRB including but not limited to: Amendments, Addendums, Investigator’s Brochure, Safety Information, Form FDA 1572s and informed consent documents.
Maintains and accurately files all necessary logs within the regulatory binders.
Expertise with regulatory procedures, HIPAA compliance, and Federal and local regulations for research on human subjects.
Supports all aspects of regulatory compliance.
Prepares, facilitates, submits and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy.
Facilitates and coordinates all aspects of IRB submissions. Include evaluating the protocol changes and incorporating those changes into the informed consent form in language understandable to the participants as required by the specific revisions made to the research protocol.
Prepares regulatory documents, including consents forms for submission to research review committees.
Communicates with research committees and administrative units, projec6t sponsors and project staff to ensure accuracy of regulatory documents and submissions.
Certification:
CITI GCP November 2016 – November 2020
CITI Biomedical September 2017 – September 2020
HIPAA September 2017 – September 2020
IATA September 2017 – September 2019
Education:
Name of Institution
Place
Degree
Year
CGPA (on scale of 4)
University of Houston Clear Lake
Texas, USA
Masters in Biotechnology (Cell and Molecular Biotechnology)
2014-2016
3.42
Gokaraju Rangaraju Institute of Engineering and Technology
Hyderabad, India
Bachelors in Biotechnology
2008-2012
4.00
Intermediate Secondary Education
Hyderabad, India
High School
Mathematics, Physics, Chemistry
2006-2008
3.70
Central Board of Secondary Education
Hyderabad
School
2005-2006
4.00
Skills and Abilities:
Management:
Planning and scheduling of research projects and required supplies.
Daily management of undergraduate students on general lab issues and lab/ equipment maintenance.
Daily management of laboratory supply inventory, ordering and receiving.
Daily generation of work accomplishment lists and monitoring of progress.
Communication:
Effective communication with public, professors in a public safety environment.
Ability to effectively and succinctly communicate with research professors and other staff in the academic and research fields.
Successful interaction with students in classroom-teaching environment and in hand on laboratory teaching environments.
Leadership:
Demonstration of leadership traits through daily performance of duties as a Teaching Assistant.
Development and demonstration of leadership traits through a variety of positions with past responsibilities as an academic event manager, research and lab management duties.
Ability to interact and provide motivation and leadership among all levels of colleagues and students.
References:
Available on request.
Contact this candidate