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
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
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