Syeda Sakina Banu
New Hyde Park,NY
Summary
Skilled multitasker with superior work ethic and good teamwork, problem-solving and organizational skills. An experienced Clinical Research Project Assistant with 5 years of experience seeking a challenging role where expertise in project coordination, regulatory compliance, and data management can be leveraged to contribute to the success of a clinical research project. Willing to take on any task to help team. Reliable and dedicated team player with hardworking and resourceful approach.
Overview
6
6
years of professional experience
Work History
Laboratory Project Coordinator II
ICON Clinical Research PVT Ltd
2021.03 - 2022.11
- Responsible for effectively assisting department's management by providing administrative support in completion of client studies and to ensure effective operation of department
- Administratively supports manager by assisting with special projects, data management, and generating validation reports for both clients and management groups:
- Actively assisting Project Managers in day-to-day monitoring of trials
- Generating, reviewing and following up on internal management reports such as open-status reports, commented results reports, etc
- Generating about 50 to 60 external management reports daily and sharing with Project Managers accordingly.
- Managing samples related to project management, e.g., running and reviewing storage data manifests and patient storage logs, coordinating outgoing shipments, etc. actively following up on test results
- Successfully implementing amendments on existing trials for review by Project Manager
- Reconciling data for interim and final locks including review of storage samples
- Handling activities in logistics related to project management, e.g., coordinating import/export information, settling up logistics for sites, etc
- Assisting setup of new protocols, including use of ICOLIMS
- Actively assist Project Manager in any ad-hoc tasks related to project management.
DRC Senior Data Coordinator
LabCorp Formerly COVANCE India Pharmaceutical Services Private Limited
2019.07 - 2020.11
- Handling data revision requests received from lab/PM/CRA/CRO, ordering test groups as per protocol, canceling test groups as per sponsor approval, deleting test groups, PVC/kit revisions, investigator site changes, updating demographic details of subjects, detachment of attachment of visits to patients based on requisition form and relabeling of containers
- Perform complex revisions to clinical data with Zavacor as per defined data revision processes, served as a Quality Assurance Delegate (QAD) for reviewing SOP/VRD files and preparing training files as per regulatory principles
- Make corrections to patient demos, safety stability issues, test reports and all laboratory circulations according to change protocol, update patient file with latest modifications in study, sample disposal and accession/visit deletion within the database
- Preparing final date files before interim and audit data lock and approvals, ensure compliance with departmental guidelines and company standards through adherence to SOPs, WIs, management communications and other patient documentation
- Active and continual coordination with PM, CRA, CROs and labs with respect to data revision/correction
- Checking and reviewing subject demographics using Zavacor database
- Relabeling of containers and moving test groups from one container to another
- Data review, data reconciliation, data revision, data correction and data compilation.
- Identified data errors and discrepancies and implemented swift corrections.
Clinical Process Assoc
IQVIA, formerly Quintiles and IMS Health, Inc
2017.06 - 2018.12
- Evaluate laboratory data through data cleaning, assembling datasets, and analysis of laboratory test results to inform purchasing of testing supplies and equipment
- Provide project and client support to clinical project coordinators (CPC), senior project coordinators, project managers and line managers
- Maintain overview of project delivery across all projects for all clients
- Coding, evaluating and interpreting collected data for assigned studies
- Actively participate in development of study protocols including guidelines for administration or data collection procedures while setting up a study protocol
- Query management of assigned project/studies
- Provided expertise as SME (Subject Matter Expertise) for Centralized Monitoring Team
- Performed internal department audits for Centralized Monitoring Team
- Identifying protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Monitored and reported on process performance to verify compliance with established standards.
Intern
BIOCON RESEARCH LTD
2017.02 - 2017.08
- In the Department of compliance and documentation:
- Responsible for assisting with preparation of all external and internal documentation for assigned trials, working on trial master file (TMF) - preparation, review, maintenance, and quality control
- Perform the tasks of organizing and preparing study files related to the findings of clinical study, assisted designee in answering and reverting on various queries
- Assisted documentation team and projects manger during the CRO visit and CRO TMF review
- Handling clinical documents like case report forms and patient informed consent forms for accurate.
- Sorted and organized files, spreadsheets, and reports.
- Participated in workshops and presentations related to projects to gain knowledge.
- Collaborated with senior management on new initiatives to build confidence.
- Completed research, compiled data, updated spreadsheets, and produced timely reports.
Education
Master of science - Life Science
Bangalore University
Bangalore - India2016
Skills
- Excellent organizational and administrative skills
- Experience in project management and coordination
- Familiarity with laboratory procedures and protocols
- Ability to work effectively in team environment
- Effective communication and interpersonal skills
- Proficient in Microsoft Office and other relevant software
- Clinical research coordination and project management
- Knowledge of Good Clinical Practice (GCP) and regulatory compliance.
- Successfully coordinated and managed multiple clinical trials simultaneously, meeting all project timelines and Implemented site communication plan for complex oncology study, resulting in improved communication and issue resolution between sites and sponsor/CRO.
- Successfully managed site budgets and payments for multiple clinical trials, ensuring timely and accurate.
- Developed and implemented comprehensive training program for site personnel on study protocols
- Procedures, and study-related documentation, resulting in improved study conduct and compliance.
- Identified and resolved data discrepancies and queries in timely manner, ensuring data integrity and Accuracy.
- SOP compliance
- Discrepancy management
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Judge a man by his questions rather than his answers.
Voltaire
Timeline
Laboratory Project Coordinator II
ICON Clinical Research PVT Ltd
2021.03 - 2022.11
DRC Senior Data Coordinator
LabCorp Formerly COVANCE India Pharmaceutical Services Private Limited
2019.07 - 2020.11
Clinical Process Assoc
IQVIA, formerly Quintiles and IMS Health, Inc
2017.06 - 2018.12
Intern
BIOCON RESEARCH LTD
2017.02 - 2017.08
Master of science - Life Science
Bangalore University
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