Clinical Research Coordinator

SYEDA SAMEENA FATIMA

Phone number:602-***-****

Email address: **************@*****.***

Motivated and experienced Clinical Research Coordinator with a Bachelor of Science in Biology, over 1 year in clinical research, and extensive background in retail and pharmacy environments. Proven ability to manage study documentation, participant recruitment, and IRB submissions while adhering to GCP/ICH regulations. Leveraged strong organizational and communication skills—honed through retail leadership and pharmacy interactions—to streamline trial workflows and maintain high participant satisfaction.

Education & Credentials

● Bachelor of Science in Biology, Kennesaw State University, Kennesaw, GA

Graduation: December 2023

Relevant Coursework: Bioethics, Good Clinical Practice

● Pre-University Studies, Sree Vani Women's College, Hyderabad, India

Focus: Mathematics, Physics, Chemistry

Certificates

●Pharmacy Technician Certificate, September 2015

● Good Clinical Practice (GCP) Certified, NIDA Clinical Trials Network, July 2023 ● HIPAA Training Certificate, March 2024

● IATA Training Certificate, March 2024

Experience

Gastroenterology Consultants, P.C. Roswell, GA

Unblinded lead Pharmacist and Coordinator (March 2024-Present)

● Coordinate the storage, handling, and preparation of investigational products in accordance with sponsor protocols, ensuring compliance and integrity throughout the clinical trial process.

● Organize and document clinical data as it was released to investigational product administration, maintaining accurate records

●Oversee and maintain the site's blinding plan

● Manage the collection, labeling, storage, administration, and shipment of lab samples, adhering to strict protocols to ensure sample integrity and compliance with regulatory standards.

● Schedule, supervise, and conduct study participants visits

● Enter patient information into the Electronic Data Capture (EDC) system, ensuring accurate and timely data entry to support study analysis and reporting.

● Order laboratory kits and investigational products, managing inventory to ensure the availability of necessary materials for ongoing studies.

● Perform lab draws according to protocol and shipped samples to central laboratories, ensuring sample integrity and adherence to study timelines.

● Coordinate monitoring visits

● Regulatory Compliance: Ensured adherence to FDA, EMA, and local guidelines, staying updated on changing regulations.

● Budgeting: Negotiated Clinical Trial Agreements, organized pre-site visits, and managed study costs.

● Endoscopy and Imaging: Collected and uploaded biopsy images and videos following protocol.

● Vendor Coordination: Familiar with platforms like Alimentive, Medidata, and Veeva Vault for data management.

● Financial Management: Managed invoices, stipends, and endoscopy-related costs.

● Site Operations: Ordered supplies, coordinated logistics, and maintained fiscal oversight.

Balancing these tasks requires attention to detail and strong organizational skills.

● Recruit patients for ongoing studies by reviewing medical histories and assessing inclusion/exclusion criteria, contributing to the successful enrollment and progression of clinical trials.

Rental Property Manager (07/2016 – Present)

Draft and execute short- and long-term leases ensuring compliance with legal requirements.

Manage accounts and budgets. Oversee financial activities to maintain profitability and support strategic decision-making.

Document short- and long-term profits and losses, keeping detailed financial report Contract skilled and unskilled laborers for various projects, coordinating resources to meet project timelines and quality standards.

Maintained profitability by putting affordable plans into effect and streamlining running operations.

Purchased and sold properties at various stages, assessing market conditions to maximize returns

On investment.

Managed renovations as required, overseeing project execution to enhance property value and appeal.

Identified and maintained relationships with new, existing, and potential lessees, fostering positive tenant relations, and ensuring high occupancy rates. CVS Caremark Contract

Pharmacy Technician (3/17/2014 – 05/17/2014)

● Tele-counseled mail-order patients on medications under pharmacist supervision. ● Managed bridge supply, drug identification, and data entry.

● Provided high customer service.

● Adhered to SOPs and HIPAA laws.

● Facilitated communication between pharmacists, managers, and patients. Generated reports within deadlines.

The limited

Sales Associate (06/2008 – 2010)

● Promoted to managerial position; chose to stay home to raise my child.

● Recognized for exemplary sales techniques and customer service.

● Managed daily sales of garments and store credit cards.

● Maintained daily accounts and handled store closing procedures. Served as retail cashier; nominated multiple times as top credit card seller. Dress Barn

Sales Associate (2010 – 2011)

● Offered Sales Manager position; declined due to pending relocation. ● Managed store closing procedures.

● Maintained daily accounts.

Non-Profit Experience

● Entered data into spreadsheets for the Cardio-Renal Society of America's Ladakh Project.

● Assisted in medical coding, focusing on cardiology and nephrology. References

● Dr. Anton Bryantsev

● Position: Associate Professor of Developmental Biology

● Institution: Kennesaw State University

● Phone: 470-***-**** or 505-***-****

● Email: ********@********.***

Dr. Waseem Ahmed, M.D.

● Position: Clinical Teams Manager

● Organization: ICON plc

● Phone: 770-***-****

● Email: ******.*****@*******.***

Skills and Knowledge

● Proficient in MS Office Suite (Excel, PowerPoint, Word) ● Experienced with Google Docs

● Skilled in Electronic Medical Records (EMR) systems ● Knowledgeable in configuring IPV4, IPV6, and DNS zones ● Basic understanding of SAS terminology and principles ● Familiar with basic laboratory principles

Medical and Pharmaceutical Knowledge:

● Proficient in medical and pharmaceutical terminology ● Understanding of FDA drug safety guidelines

● Knowledge of pharmacy practice ethics

● Familiarity with pharmacology of medications

● Experience in patient care and interaction

Language Proficiency:

● Fluent in English, Hindi, and Urdu

● Elementary proficiency in Italian

Contact this candidate