Sr. Drug Safety Specialist
Resume:
Nidhi Prem, MBBS
Sr. Drug Safety Specialist
Washington
8+ years in the clinical research industry
4.5 years regional and in-house monitoring experience
2.5 years as Clinical Research Coordinator for neurology, stroke and oncology trials
Medical degree (Bachelor of Medicine, Bachelor of Surgery – MBBS)
2 years’ experience as an physician in India treating patients in the emergency department
Experience with site feasibility, site selection/initiation/monitoring/close-out visits, investigator meetings (attendance and preparation), GCP training, query resolution, management of SAEs, drug accountability, remote data entry, budget negotiations, collection of regulatory packages, enrollment tracking.
1 year relevant work experience in Drug Safety managing large long term Safety phase 4 trials.
Therapeutic area
Oncology
• Prostate cancer
• Pre-malignant oral lesions
• Sarcoma
Neurology
• Stroke
• Alzheimer’s disease
Psychiatry
• Dementia
• Schizophrenia
• Psychosis
Gynecology
• Polyps
• Endometriosis
• Fibroids
Endocrine
• Diabetes
• Anemia’s Dermatology
• Actinic Keratosis
• Acne
• Warts
• Vitiligo
• Psoriasis
• Scabies
• Actinomycosis
Respiratory
• Tuberculosis
• Common Cold
• Guillain Barre syndrome
Infectious Diseases
• Malaria
• Kala azar
• Dengue
• Ameobiasis
Gastrointestinal
• Gastro Intestinal Ulcers
• Esophageal atresia
• Gastro Esophageal Reflux Disease
PROFESSIONAL EXPERIENCE
Clinsys Clinical Research, Inc.
Sr. Drug Safety Specialist May 2010 – Present
• Responsible for SAE reconciliation data for periodic safety update reviews
• Completed some or all tasks in preparing, tracking and reporting SAE’s.
• Assured SAE’s are transmitted in timely fashion to the Sponsor, I and regulatory authorities.
• Prepared Standard Operating Procedures for SAE reporting requirements.
• Conduct direct enquires at participating sites to verify records and SAE Follow ups.
• Assisted to establish protocol specific notifications procedures for Adverse event reporting requirements
• Performed external data status applications and input for project cycle time.
• Offered guidance and acted as liaison with CRA and site questions.
• Provided hotline support for query resolutions and site questions.
• Created project essential documents.
• Designated to train new staff and employees to accomplish study related goals.
• Triage of incoming cases to determine seriousness for prioritization of daily workflow.
• Create initial reports by directly entering information into Drug Safety databases, amend reports and enter follow-up information as acquired, and prepare report for Sponsor submission.
• Maintain continuous knowledge expertise in local and global requirements for safety reporting.
• Coordinate submission of technical complaints to the Quality Assurance dept. and the matching of technical complaints that also involve adverse events.
• Adhere to departmental timelines for expedited reports from clinical and post-marketing safety surveillance.
• Collaborate with Medical, Regulatory and Clinical teams in review of safety information.
• Manage prioritization of cases, accurate case registration and data entry
Clinical Research Associate II, November 2008 – April 2010
• Participate in the identification of potential qualified investigators and clinical sites as required, including initial contact with potential investigators and conducting pre-qualification visits
• Participate in the collection, review and tracking of regulatory documents, both pre-study and throughout the trial as required
• Attend Investigator Meetings, Sponsor meetings, Kick-off/Rally meetings and Clinsys meetings as required
• Participate in the development of study specific project plans, monitoring tools, etc.
• Act as a liaison between the Project Manager and study site personnel to obtain and provide timely communication of site issues including enrollment status, protocol deviations/violations, SAEs, and other site issues
• Conduct Site Initiation Visits in accordance with the study specific Clinical Monitoring and Site Management Plan, including advising and training site personnel on Sponsor and regulatory requirements for study conduct
• Assist site personnel with the development of recruitment strategies and enrollment plans
• Conduct Interim Monitoring Visits per the schedule defined in the study specific Clinical Monitoring and Site Management Plan to ensure compliance with the study protocol, GCP/ICH regulations, Clinsys/Sponsor SOPs and overall clinical objectives
• Review site files and records, investigational product accountability records, case report forms and source documents for accuracy, completeness, consistency and compliance; identify deficiencies and discrepancies; provide additional training and initiate corrective action as required
• Conduct Close-out Visits per the study specific Clinical Monitoring and Site Management Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution and resolution of outstanding action items
• Document and maintain all site contacts utilizing the Site Contact Form
• Advise and train study site personnel on sponsor and regulatory requirements for study conduct, adequate screening and enrollment of study subjects, data management expectations and adherence to study specific timelines
• Prepare timely and accurate monitoring reports, confirmation letters and follow-up letters for all site visits as per the study specific Clinical Monitoring and Site Management Plan
• Prepare expense reports, manage time, and schedule subsequent visits in accordance with sponsor expectations and within the study budget
• Co-monitor and assist other CRAs as needed, especially for data deadlines and database locks
Clinical Research Associate, February 2008 – October 2008
• Conduct site-monitoring visits to perform source document verification, protocol compliance, regulatory compliance, and drug accountability
• Prepare reports on study status and monitoring activity
• Track pre-study documents and other regulatory documents during the course of the study at assigned sites, as required
• Assist in the identification of qualified investigators; including contacting potential investigators and conducting pre-study visits
• Provide instruction to research site personnel on proper conduct of study to ensure timely and proper completion of data by assigned clinical sites
• Assist with the follow-up of serious adverse events; reconcile SAEs with the clinical data (CRF/RDE)
• Assist in the resolution of data queries
Prakash Neurological Centre – Meerut, India, January 2001 – October 2007
Clinical Research Associate, January 2005 – October 2007
• Researched, prepared, and updated clinical protocols, instructions for use
• Informed consents, reports of prior investigations, bibliography, case report forms (CRFs), clinical trial reports, and other study-related documents in consultation with the cross-functional project team, investigators, data management, and biostatistics
• Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, patient enrollment, follow up, and study closure activities
• Developed and managed study budgets, timelines, and resource requirements
• Managed all outsourced activities for assigned trials
• Provided management level representation during audits
• Performed monitoring and auditing at participating sites, CROs, Core Labs, etc., to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies
• Conducted ongoing review of adverse event information
• Compiled and updated adverse event logs
• May interface with regulatory agencies, as appropriate
• Conducted/supervised training of investigators, site staff, and internal clinical staff
• Conducted/supervised site initiation activities
• Set-up and maintained (or supervised) accurate study status and accountability logs
• Reviewed data listings and tables
• Educated internal/external data management on the clinical context of these documents and provide oversight of data reconciliation
• Evaluated clinical data/information, wrote, and revised annual, interim, and final reports and clinical sections of regulatory submissions
• Oversaw clinical research staff and performed personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives)
Clinical Research Coordinator/Project Manager, November 2002 –Dec 2005
• Identification and recruitment of potential research participants
• Created and developed information materials to improve subject knowledge and increase enrollment
• Reviewed all new protocols to determine the requirements for implementation
• Identification and recruitment of potential research participants
• Screened for potential research participants through evaluation of subjects using inclusion/exclusion criteria and protocol specified eligibility requirements
• Explained research study to potential participants and ensured that informed consent was obtained prior to initiation of any study related procedures
• Ensured that participants received consent copies with all appropriate signatures
• Performed basic laboratory procedures including blood, tissue and/or body fluid collection and processing (if required)
• Performed insertion of intravenous catheters
• Performed protocol specified procedures (i.e. Vital signs, Electrocardiograms etc…)
• Performed administration of research interviews and all research related questionnaires
• Supervised and assumed responsibility for administration of study medication administration
• Received, inventory and returned shipments of all study medications and related supplies
• Maintained drug accountability records
• Coordinated with Principal Investigator and central administration to help ensure that clinical research and related activities were performed in accordance with regulations and sponsoring agency policies and procedures
• Assisted Principal Investigator to create, review protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities
• Assured appropriate and safe research participant management according to protocols
• Assisted with ongoing communication to research participants and families and collect, record and maintain records of all data collected on research participants
• Coordinated with the Principal Investigator to prepare a categorized budget and justification and confirmed accuracy and completeness of budgeted costs
• Assisted Principal Investigator to prepare, submit, or modify scientific protocol in accordance with regulations and University and sponsoring agency policies and procedures
• Assisted Principal Investigator to submit accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures
Doctor Family Physician/Surgeon Assistant, January 2001 – November 2002
• Responsible for emergency management and diagnosis of patients and seeing around 50 patients/day
• Helped senior doctors with brain and heart surgeries
• Helped out in overall management of the hospital
EDUCATION
Bachelor of Medicine and Surgery (M.B.B.S.), equivalent to M.D., Himalayan Institute of Medical Science, Dehradun, UP India
CERTIFICATIONS / PROFESSIONAL TRAINING
Effective Clinical Trial Design, CIPLA Pharmaceutical Ltd.
Good Clinical Practice (GCP), ICH & FDA regulations Training: Certified, CITI Collaborative Institutional Training Institute
Efficient Clinical Trial Monitoring Design and Data Collection, Nicholas Piramal India Ltd.
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