Summary

Overview

Work History

Education

Skills

current location

recruiter's summary/ comments

degree or certificate

candidate name

Timeline

Devendra Vemulupalli

Harrisburg,PA

Summary

Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Knowledgeable adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. Hardworking and passionate job seeker with strong organizational skills. Ready to help team achieve company goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

years of professional experience

Work History

Clinical Trial Associate

Strongbridge Biopharma

02.2022 - 09.2023

Worked with day-to-day aspects of CTA's for assigned trials and provide efficient updates on trial progress to the Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management
Ensure effective project plans are in place and operational for each trial and work proactively with the clinical team to set priorities in accordance with applicable project plans, Company's SOPs, ICH/GCP guidelines and regulatory requirements
Create and review Pre-study, Site Start-Ups, Initiation, Monitoring, and close-out visits reports; ensure tracking, telephone contacts, and follow-up all outstanding clinical trial site issues to resolution and/or documenting attempts in company's Clinical Trial Management System (CTMS) to resolve all issues following close-out of clinical trial sites
Conduct sponsor study start-up process and clinical trial site management
Acted as Primary contact with investigative sites during site start-up activities
Hands on experience in working with Investigative sites to collect the required investigator and regulatory essential documents for a study and ensure that the documents meet the specifications required by local regulations, ICH-GCP, FDA, and Sponsor
Ensure all study documentation is filed in the TMF in accordance with company's SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance, and archival procedures
Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.) and responsible for maintenance of regulatory documents
Reviewed regulatory documents as required for inspection readiness
Ensured the timely completion of Contracts, IRB submission & approvals and subject enrollments

Clinical Document Quality Coordinator

Eisai

07.2017 - 09.2021

Ensure all study documentation is filed in the TMF in accordance with company's SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
Ensure effective project plans are in place and operational for each trial and work proactively with the clinical team to set priorities in accordance with applicable project plans, Company's SOPs, ICH/GCP guidelines and regulatory requirements
Review e-CRFs and performed source document verification (SDV)
Review Investigator study files, Informed Consent forms and regulatory documents
Maintained and evaluated subject enrollment, managed investigator payments, maintained documentation of communication with the site, and ensured adequacy of the supplies at the site
Ensured data cleaning activities are performed on time and with quality data
Performed Quality control review of TMF to ensure all essential documents are within the file, in the appropriate sections with SOPs and industry standards
Manages overall performance of TMF process to drive quality and compliance across the organization to ensure that all operational objectives are met
Provide business support to all TMF users by problem-solving issues, from onset to resolution, using the applicable software
Create and maintain the support structures for the system
Ability to extract pertinent information from all study documents such as protocols, informed consents, contracts, etc
Facilitate the set-up of trials in the Trail Management File (TMF) by working closely with project managers to interpret requirements for conducting a trial and then customizing the system to meet those requirements
Excellent research coordination skills/understanding pertaining to all phases of clinical trials
Track progress of clinical studies, ensuring projects meet timelines and quality expectations and Configure CTMS system to align with department goals and processes
Maintains central study files (including regulatory documents) for assigned projects

Clinical Trial Assistant (Internship)

Karyopharm Therapeutics

10.2016 - 04.2017

Prepare and maintain the Trial Master File (TMF) for the study while assisting clinical Operations management team in quality checking and raising finding as per the TMF guidance to documents like but not limited to Protocols, Protocol Amendments, clinical trial agreements, budgets, correspondence etc
Reviewed monitoring visit reports, updating TMF plan and communicated with respective document owner in remediation process
Extensively involved in set-up, maintenance, quality review and tracking of clinical trial master file documents (Paper and e-TMF)
Tracked and reviewed Pre-Study, Initiation, Interim, and Close-Out Monitoring Visits and monitoring report submissions
Participate in preparation of regulatory submissions that are necessary to initiate and maintain clinical studies including clinical study report, safety reports, and FDA annual reports
Tracked the progress of the clinical trial, attended the clinical team meetings which includes scheduling and taking minutes
Maintained, reviewed, reconciled and archived clinical trial master file documents, including and not limited to clinical study site documents, training materials, email correspondence and other study documents