MS Word
Amna Hashmi
Clinical Research Associate
Lahore
Summary
Detail-oriented and highly organized Clinical Research Associate (CRA) with [X] years of experience in monitoring and managing clinical trials across multiple therapeutic areas. Skilled in ensuring compliance with ICH-GCP, FDA, EMA, and other regulatory guidelines, conducting site visits, and maintaining high-quality data integrity. Adept at site initiation, monitoring, and close-out activities, ensuring patient safety, and collaborating with investigators and site staff. Proficient in using electronic data capture (EDC) systems and resolving protocol deviations efficiently. Strong communication, problem-solving, and analytical skills, committed to delivering high-quality clinical research outcomes.
Overview
6
6
years of professional experience
12
12
years of post-secondary education
11
11
Certifications
2
2
Languages
Work History
Clinical Research Associate
Mayo Hospital
07.2024 - Current
- Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with study protocols and regulations.
- Ensure proper site adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements (FDA, EMA, ICH-GCP).
- Verify that informed consent procedures are correctly followed and documented.
- Ensure the proper handling, storage, and accountability of investigational products.
- Identify and resolve issues at study sites, including protocol deviations, data discrepancies, and regulatory non-compliance.
- Review source documents, case report forms (CRFs), and electronic data capture (EDC) entries for accuracy and completeness.
- Ensure adverse events (AEs) and serious adverse events (SAEs) are reported and documented properly.
- Work closely with investigators and site staff to ensure timely and accurate data collection.
- Assist in the development and review of study-related documentation, including protocols, monitoring plans, and site training materials.
- Serve as the main point of contact between the sponsor, contract research organization (CRO), and clinical trial sites.
- Provide training and support to investigators, study coordinators, and site staff.
- Communicate findings from monitoring visits and provide recommendations for corrective actions.
- Participate in investigator meetings, study team discussions, and regulatory audits as needed.
- Ensure sites comply with ethical guidelines, Institutional Review Board (IRB) or Ethics Committee (EC) requirements, and local/international regulatory requirements.
- Assist in preparing and submitting regulatory documents to authorities as required.
- Maintain detailed documentation of site visits, issues identified, and actions taken in monitoring reports.
- Support study start-up activities, including feasibility assessments and site selection.
- Assist with study drug or device accountability and reconciliation.
- Monitor patient recruitment and retention efforts to ensure timely study completion.
- Oversee resolution of queries related to data entry and protocol adherence.
Unblinded Pharmacist
Mayo Hospital
05.2023 - 08.2024
- Prepare, compound, and dispense investigational oncology drugs according to study protocols.
- Maintain accurate drug accountability records, including receipt, storage, dispensing, and destruction per regulatory requirements.
- Ensure proper storage and handling of investigational products (IP) per manufacturer and protocol guidelines.
- Manage drug inventory and coordinate resupply orders with the sponsor or drug manufacturer.
- Handle unblinded study medication while ensuring that blinded study team members remain unaware of treatment allocations.
- Maintain strict confidentiality regarding treatment assignments, ensuring blinding integrity is preserved for other study personnel.
- Collaborate with blinded and unblinded study team members to ensure proper drug administration while preventing unintentional unblinding.
- Ensure adherence to GCP, GMP, institutional policies, and regulatory requirements (e.g., FDA, EMA, ICH).
- Accurately document drug preparation, administration, and accountability in study-specific records.
- Prepare for and participate in monitoring visits, audits, and regulatory inspections.
- Work closely with investigators, study coordinators, and oncology care teams to support patient treatment schedules.
- Provide guidance on safe handling and administration of oncology trial medications.
- Communicate with sponsors, contract research organizations (CROs), and regulatory bodies regarding drug-related concerns.
Oncology Pharmacist
ONCOLOGY MD
02.2023 - 05.2023
- Prepare, compound, and dispense chemotherapy, targeted therapies, immunotherapies, and supportive care medications.
- Ensure accurate dosing, preparation, and administration of oncology drugs per treatment protocols.
- Monitor for chemotherapy toxicities, drug interactions, and adverse effects.
- Adjust dosages based on patient-specific factors such as renal/hepatic function, genetic markers, and lab results.
- Maintain compliance with USP and standards for hazardous drug handling.
- Work closely with oncologists, nurses, and other healthcare professionals to develop individualized treatment plans.
- Participate in tumor boards, clinical rounds, and treatment planning discussions.
- Provide expert recommendations on chemotherapy regimens, premedications, and supportive care strategies.
- Educate patients and caregivers on chemotherapy regimens, side effects, and adherence strategies.
- Provide guidance on managing nausea, fatigue, pain, and other chemotherapy-related side effects.
- Ensure patients understand medication safety, including handling precautions for oral chemotherapy at home.
- Ensure adherence to safety protocols for handling, storing, and disposing of hazardous drugs.
- Monitor and report adverse drug reactions (ADRs) and chemotherapy-related toxicities.
- Participate in medication safety initiatives and quality improvement programs.
- Conduct audits and ensure compliance with institutional policies, regulatory bodies (FDA, EMA), and accrediting organizations (JCI, ASHP).
- Stay updated on advancements in oncology treatments, clinical trials, and emerging therapies.
- Support clinical trials by managing investigational oncology drugs and ensuring protocol adherence.
- Conduct research, publish findings, and contribute to oncology pharmacy advancements.
- Train and mentor pharmacy students, residents, and healthcare staff on oncology pharmacotherapy.
Warehouse Pharmacist
ALAQ LABORATORIES
02.2022 - 02.2023
- Oversee the proper storage of medications, ensuring compliance with temperature control and environmental conditions.
- Monitor and maintain stock levels, ensuring timely ordering and restocking of pharmaceutical products.
- Ensure accurate record-keeping of inventory, batch numbers, and expiry dates to prevent stockouts or wastage.
- Perform regular inventory audits and reconciliation to detect and prevent discrepancies.
- Ensure warehouse operations comply with Good Distribution Practices (GDP), Good Storage Practices (GSP), and Good Manufacturing Practices (GMP).
- Maintain compliance with national and international pharmaceutical regulations (e.g., FDA, WHO, EMA, MHRA).
- Conduct regular checks to ensure proper handling, packaging, labeling, and transportation of pharmaceutical products.
- Assist in audits and inspections by regulatory authorities and internal quality teams.
- Review and verify prescriptions or wholesale orders before dispatch.
- Ensure accurate picking, packing, and dispatch of pharmaceutical products to healthcare providers, pharmacies, and hospitals.
- Work closely with logistics teams to track shipments and resolve delivery issues.
- Implement cold chain management protocols for temperature-sensitive medications.
- Ensure proper handling and disposal of expired, damaged, or recalled medications.
- Monitor and enforce safety protocols for hazardous substances and controlled drugs.
- Train warehouse staff on safe handling procedures and regulatory compliance.
- Work closely with procurement teams to ensure timely replenishment of stock.
- Liaise with suppliers, manufacturers, and regulatory authorities for product-related issues.
- Provide guidance and support to warehouse staff regarding pharmaceutical regulations and best practices.
Clinical Pharmacist
ALI LIFE CARE HOSPITAL
11.2021 - 02.2022
- Review and assess patient medication regimens to ensure safety, efficacy, and appropriateness.
- Provide recommendations on drug therapy adjustments based on patient-specific factors such as kidney function, liver function, and comorbidities.
- Monitor patients for therapeutic effectiveness, adverse drug reactions (ADRs), and drug interactions.
- Collaborate with physicians, nurses, and other healthcare professionals to develop individualized treatment plans.
- Participate in medical rounds with healthcare teams to provide pharmacological expertise.
- Advise healthcare providers on drug alternatives, cost-effective treatments, and latest clinical guidelines.
- Assist in the management of antimicrobial stewardship programs, pain management, or chronic disease management.
- Educate healthcare professionals and patients on medication use, side effects, and adherence strategies.
- Ensure compliance with hospital policies, national guidelines, and regulatory requirements (e.g., FDA, EMA, JCI).
- Identify and report medication errors or adverse drug events, implementing corrective actions as needed.
- Participate in quality improvement initiatives, such as reducing polypharmacy and optimizing high-risk medication use.
- Provide counseling to patients on proper medication use, potential side effects, and lifestyle modifications.
- Educate patients on anticoagulation therapy, diabetes management, or other specialized drug therapies.
- Promote medication adherence and prevent medication-related complications through patient engagement.
- Stay updated on new drug developments, clinical guidelines, and emerging treatment strategies.
- Conduct or participate in clinical research, audits, and drug utilization reviews.
- Mentor pharmacy students, interns, and residents in clinical pharmacy practices.
Intern as Pharmacist
SERVAID+ PHARMAC
06.2019 - 07.2019
- Clinical Skills: worked at Servaid+ Pharmacy my duties were to take care about patient’s prescription, Drug-Drug interactions, monitoring of safe use of medicines and dosage regimen
Education
M-Phil - Pharmacology
Lahore College For Women University
Lahore, Punjab 05.2023 - 01.2025
Doctor of Pharmacy (Pharm-D) - undefined
PUNJAB UNIVERSITY COLLEGE OF PHARMACY
Lahore, Punjab 01.2016 - 01.2021
B.A - undefined
UNIVERSITY OF THE PUNJAB
Lahore, Punjab 01.2017 - 01.2019
Intermediate - Pre-Medical
GOVT. ISLAMIA COLLEGE FOR WOMEN, LAHORE CANTT
Lahore, Punjab 01.2013 - 01.2016
Skills
SPSS 23
MS Word
MS PowerPoint
MS Excel
Clinical documentation
Clinical data management
IRB submissions
Quality control
Data evaluation
Project management
Study design
Site management
Patient recruitment
Case report forms
Data collection
Electronic data capture
Site monitoring
Medical writing
ICH guidelines
Clinical study reports
Clinical research coordination
Clinical trial management
Drug development
Drug accountability
Protocol review
Team collaboration
Trial oversight
Study monitoring
Investigator coordination
Trial management
Extra-Curricular Activities
PUCP-SPORTS GALA 2021, Lahore, Punjab, Pakistan, Leader, 03/01/21, 04/30/21, Managed and organized sports games for students.
Honors And Awards
- Academic Scholarships, Lahore, Punjab, Pakistan, Received full merit-based scholarship from PUCP (2016-2018)
- Online Courses, Lahore, Punjab, Pakistan, Completed IDF online short course on Prevention of type 2 Diabetes and CVD (2020)
- Awards and Certifications, Lahore, Punjab, Pakistan, Career-Prep Fellow at Amal Academy (08/01/21 - 10/31/21)
Technical Skills
- SPSS 2.3
- MS Word
- MS PowerPoint
- MS Excel
Personal Information
Age: 26
Software
SPSS 23
Certification
Medical Errors Assessment-Stanford University
Interests
Cricket
Calligraphy
Gardening
Current affairs
Cricket, Calligraphy, Gardening, Current affairs
Cricket: Demonstrates teamwork, strategic thinking, leadership, and physical fitness. Highlights your ability to collaborate and perform under pressure.
Calligraphy: Reflects creativity, patience, attention to detail, and artistic skills. Shows a keen eye for precision and aesthetics.
Gardening: Indicates patience, dedication, and an appreciation for nature. Suggests a methodical approach to tasks and the ability to nurture and sustain projects over time.
Current Affairs: Shows awareness of global trends, analytical thinking, and an interest in staying informed. Demonstrates intellectual curiosity and a proactive approach to learning.
Timeline
Research Study Design (RSD)
08-2024
Clinical Research Associate
Mayo Hospital
07.2024 - Current
Regulatory Updates For Clinical Research Professionals By Socra
07-2024
Personnel GCP Training NIDA
01-2024
Gep Course by LSHTM
07-2023
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
07-2023
Unblinded Pharmacist
Mayo Hospital
05.2023 - 08.2024
GCP-NIDA Clinical Trials
05-2023
M-Phil - Pharmacology
Lahore College For Women University
05.2023 - 01.2025
Oncology Pharmacist
ONCOLOGY MD
02.2023 - 05.2023
Warehouse Pharmacist
ALAQ LABORATORIES
02.2022 - 02.2023
Clinical Pharmacist
ALI LIFE CARE HOSPITAL
11.2021 - 02.2022
Women Empowerment
09-2020
Role of Pharmacist in Hospitals
09-2020
Medical Errors Assessment-Stanford University
04-2020
How to Taper Patients Off Opioids- Stanford University
04-2020
Pestilence, Plague and Prevention-Griffith University
04-2020
Intern as Pharmacist
SERVAID+ PHARMAC
06.2019 - 07.2019
B.A - undefined
UNIVERSITY OF THE PUNJAB
01.2017 - 01.2019
Doctor of Pharmacy (Pharm-D) - undefined
PUNJAB UNIVERSITY COLLEGE OF PHARMACY
01.2016 - 01.2021
Intermediate - Pre-Medical
GOVT. ISLAMIA COLLEGE FOR WOMEN, LAHORE CANTT
01.2013 - 01.2016