SEENAM SHARMA
Calgary,AB
Summary
Dedicated Clinical Research Coordinator with 7 years of experience in clinical research and drug safety across various therapeutic areas including Cardiology, Dermatology, Oncology, and Pulmonary medicine. Skilled in patient recruitment, data collection, IRB submissions, adverse event reporting and regulatory documents maintenance with strong understanding of Alberta health systems, ICH-GCP requirements, TCPS2, Heath Canada Div5 and FDA regulations.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
University of Calgary
Calgary
01.2024 - Current
- Recruit, screen, obtain consent and coordinate study participant visits in accordance with study protocols for industry sponsored clinical trials.
- Oversee data collection by completing electronic case report forms via EDC databases such as RedCap, Medidata Rave and INform.
- Create source document worksheets in accordance with the study protocol.
- Receive and verify study supplies and conduct drug accountability.
- Maintain regulatory files including regulatory binder, training logs, delegation logs and other essential documents.
- Communicate effectively with study sponsors to resolve database queries and coordinate monitoring visits.
- Manage study finances, including invoicing for milestone completion and monitoring accounts with meticulous record keeping.
- Demonstrate knowledge and adherence to university processes related to research activities.
- Primary research coordinator for Amyloidosis registries, responsible for regulatory documentation, ethics approvals, AHS approvals, data collection and invoicing.
- Manage the Undergraduate Student Research program by conducting student interviews, onboarding participants, facilitating necessary access, training students in data collection and supervising data entry.
- Liaise with team members and stakeholders across institutional departments and disciplines, including Principal Investigators, clinic nurses, students, AHS staff, CRO and research accounting
- Organize regular meetings with various working groups, such as the Amyloidosis Program of Calgary, AB Amyloidosis Working Group, Canadian National Society and PANN
- Create meeting agendas and minutes for monthly Amyloidosis Program of Calgary meetings and lead team meetings as applicable.
- Develop reports, surveys, and PowerPoint presentations as needed and assist in planning Amyloidosis Program of Calgary events.
- Contribute to the maintenance of the Amyloidosis Program of Calgary Website and manage Amyloidosis Program of Calgary mailbox.
Clinical Research Coordinator
Wiseman Dermatology Research
Winnipeg, Canada
05.2023 - 12.2023
- Recruited study participants by identifying and screening potential subjects, obtaining informed consent, and conducting and administering questionnaires or other data collection tools
- Managed and organized regulatory documentation, maintaining meticulous records for audits and inspections
- Interfaced with regulatory authorities, maintaining effective communication and addressing queries promptly
- Oversaw adherence to study protocols, ensuring the integrity and quality of clinical research
- Contributed to the development and submission of regulatory documents, supporting successful approvals
- Documented all protocol deviations and reported them to regulatory authorities
- Coordinated with CRAs during monitoring visits for all monitoring aspects and completed data retrieval
- Conducted patient visits and made preparations for those visits
- Maintained training logs and delegation of authority logs for each study
- Engaged in data management duties, which involved tasks such as data entry and addressing queries within clinical databases
- Executed all aspects of study visits, including assessment, adverse events, monitoring safety, medication, questionnaires, sample collection, processing, and shipment of samples according to protocol
Drug Safety Associate
Elite Safety Sciences
Bridgewater, USA
01.2023 - 10.2023
- Performed triage, duplicate search, data entry for incoming ICSR reports (post marketing and clinical trial), considering assessments of validity, seriousness, listedness, causality and significance of follow-up information received
- Executed duplicate case checks in the Argus safety database
- Experienced in maintaining a good knowledge of the safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations
- Conducted data entry into the safety database, including report type, case classification, MedDRA coding of events and product selection
- Performed quality checks of ICSRs to ensure high quality of the reports in accordance with client SOPs and regulatory requirements
- Produced urgent queries as needed for clarification of clinical reports
- Implemented quality check and oversight of sponsor established product complaint processing as outlined or directed by sponsor
- Trained and experienced in audit preparation, regulatory inspections, CAPA investigations and program compliance
Drug Safety Associate
Parexel international
Mohali, India
11.2017 - 02.2022
- Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) with focus on clinical trial cases
- Performed Triage, duplicate search and Data entry of ICSRs in the safety database, including writing clinical narratives
- MedDRA coding, case processing, raising follow up queries in clinical database reconciliation Via SDARFs, determining the expectedness of adverse events against various labeling documents
- Performed book in for all types of cases such as E2B, LAM and mailbox
- Raised follow up queries and action items as per missing or discrepant information
- Strong knowledge of ICH, GCP, GVP, US-FDA, Health Canada, MHRA, EMA and TGA safety reporting requirements
- Expertise in causality assessment and processing of SUSAR/SESAR case reports
- Extensive hands on experience with coding dictionaries including Meddra and WHO drug dictionaries and sound knowledge of CIOMS and MedWatch forms
Dental Intern
Gian Sagar Dental College and Hospital
Mohali
08.2016 - 08.2017
- Examined patients for various dental health diseases.
- Observed proper sterilization techniques of all instruments used in the clinic.
- Monitored and assessed patients' vital signs prior to procedures.
- Collected and documented medical history for patients.
- Administered local anesthesia to patients prior to dental procedures.
- Maintained charts of patient visits, treatments performed, medications prescribed.
- Performed procedures such as restorations, tooth extractions and scaling.
- Performed pediatric dental procedures, including fillings and extractions, ensuring a child-friendly environment.
- Educated children and their guardians on oral hygiene practices and post-treatment care.
- Supported the coordination of patient schedules and facilitated effective communication between patients and the dental team.
Education
Bachelors of Dental Surgery -
Gian Sagar Dental College and Hospital
01.2017
Skills
- Connect Care
- Epic
- IRISS
- REDcap
- Medidata Rave
- INform
- Argus Safety
- MedDRa Coding
- WHO drug dictionary coding
- Microsoft Office Suite
- Attention to detail
- Excellent prioritization skills
- Ability to work independently
- Presentation skills
Certification
- ICH Harmonized Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2)
- Health Canada Food and Drug Regulations Part C, Division 5: Drugs for Clinical Trials involving Human Subjects
- Research Ethics based on the Tri-Council Policy Statement: Ethical conduct for Research involving Humans (TCPS 2: Core 2022)
- Transportation of Dangerous goods TDG/IATA
- N2 Clinical Research Standard Operating procedures
- AHS Information Privacy & IT Security Awareness
- Introduction to Pediatric Oncology, St. Jude Children's Research Hospital, Oct 2024
Languages
- English
- Punjabi
- Hindi
Timeline
Clinical Research Coordinator
University of Calgary
01.2024 - Current
Clinical Research Coordinator
Wiseman Dermatology Research
05.2023 - 12.2023
Drug Safety Associate
Elite Safety Sciences
01.2023 - 10.2023
Drug Safety Associate
Parexel international
11.2017 - 02.2022
Dental Intern
Gian Sagar Dental College and Hospital
08.2016 - 08.2017
Bachelors of Dental Surgery -
Gian Sagar Dental College and Hospital
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