United States citizen with Bachelor’s degree in Medicine and Bachelor’s degree in Surgery [MBBS] from the University of Karachi. Experienced in many therapeutic areas including, women’s health, gastroenterology, pulmonary, cardiology, endocrinology, and neurology.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Director of Health Clinics
NAIC NGO
Sacramento, CA, USA
05.2020 - 06.2025
Oversaw clinical teams and monitored workflows, ensuring compliance with standards and optimizing service delivery.
Addressed patient concerns and resolved operational issues to maintain high patient satisfaction.
Led and supervised clinical and administrative staff, including hiring, training, performance, evaluation, and scheduling.
Clinical Research Associate I
Syneos Health
Morrisville, NC
10.2018 - 06.2019
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely).
Verify that investigator and investigator’s team are adequately trained and comply with the protocol.
CRA Responsibilities
Research Coordinator II
Baylor college of Medicine-Gastroenterology
Houston, TX
03.2018 - 10.2018
Completion of regulatory documents and IRB submission.
Attending investigator meeting as required.
Obtain patient consent and enroll subjects into appropriate research studies, making every effort to ensure that all eligibility criteria are met.
Schedule subjects for all pre-study, interim, and follow up assessments, per protocol.
Facilitates and coordinates the daily clinical trial activities.
May perform Venipuncture (blood draws) and obtain vital signs, EKG on study participants.
Collection of biopsies.
Collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
Ensure accurate data collection, documentation, organization, and safety of research participants.
Complete case report forms (electronic and paper) and resolve data queries/DCFs within sponsor-defined timelines.
Coordinate monitoring visits between CRAs and investigators, and work closely with CRAs during visits to ensure study data is accurate and source documented in accordance with GCP and ICH guidelines.
Communicate with IRBs, according to their guidelines, on initial submissions, annual renewals, administrative changes, and if applicable, protocol deviations.
CRC Responsibilities
Clinical Research Coordinator Sr
Spring Clinical Research
Houston, TX
10.2015 - 01.2018
Independently coordinate numerous protocols, including patient recruitment, and conducting screening procedures.
Review and develop a familiarity with the protocol (study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections).
Comply with protocols, GCP and ICH guidelines, and regulatory requirements.
Explain process and procedures to educate participants regarding the research study.
Coordinate all aspects of patient participation in research studies, and schedule subjects for all pre-study, interim, and follow up assessments, per protocol.
Complete Case Report Forms (electronic and paper) and resolve data queries/DCFs within sponsor-defined timelines.
Perform pharmacokinetic (PK) sampling, specimen processing, and shipment of blood samples to central laboratories.
Maintain patient research charts (source documents) and manage regulatory files/Investigator Site File.
Coordinate monitoring visits between CRAs and investigators, and work closely with CRAs during visits to ensure study data is accurate and source documented in accordance with GCP and ICH guidelines.
Scheduling and conducting on site or remote Site Close out visits and train new study coordinators on research protocols.
CRC Responsibilities
Education
Bachelor’s in Medicine and Bachelor’s in Surgery - MBBS
University Of Karachi
Pakistan
01-2005
Skills
Well-versed in medical terminology
Sound understanding of medicine
Experience in Epic, Athena, e-Clinical and PrognoCIS EMR
Proficient in Microsoft Word, Excel, and Power Point
ECRF competence in InForm, Oracle, and Medidata Rave
Experience in CTMS, eTMF and veeva Vault
Experience in phase II, III and IV clinical trials
Self-confident, fast learner, and hard-working
Certification
SOCRA Certification (CCRP)
Collaborative Institutional Training Initiative (CITI)
Certification in Family Medicine
COVID-19 Training for Healthcare Workers (Coursera)
TeleOBGYN 12 Weeks Virtual Course
Mayo Clinic (IATA)
Basic Phlebotomy
Languages
English
Hindi
Urdu
Timeline
Director of Health Clinics
NAIC NGO
05.2020 - 06.2025
Clinical Research Associate I
Syneos Health
10.2018 - 06.2019
Research Coordinator II
Baylor college of Medicine-Gastroenterology
03.2018 - 10.2018
Clinical Research Coordinator Sr
Spring Clinical Research
10.2015 - 01.2018
Bachelor’s in Medicine and Bachelor’s in Surgery - MBBS
University Of Karachi
Past (non-research) Professional Experience
Portfolio representative for Account Control Technology
2905 Sherwood Way, San Angelo, TX 76901
List of study protocols
A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease. Protocol Number: RECD3126.
DAL-301: A phase III, double-blind, randomized, placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis.
A Repeat-dose Study in Subjects with Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multi-Center Study with a 78-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy: MK-8835-007/B1521017.
Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (Protocol B1481038 / SPIRE-2).
Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (Protocol B1481022 / SPIRE-1).
Protocol number: 16GI01 Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment with LT 02 (Delayed Release Phosphatidylcholine Granules) vs. Placebo in Subjects with Ulcerative Colitis Refractory to Standard Treatment with Mesalamine.
RHB-104-01: A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease.
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Cardiovascular Outcomes following Treatment with Ertugliflozin (MK-8835/PF-04971729) in Subjects with Type 2 Diabetes Mellitus and established Vascular Disease; MK-8835-004/B1521021
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD exacerbations over a 52-Week Treatment Period in Subjects with moderate to very Severe COPD.
Cardiovascular Inflammation Reduction Trial (CIRT): A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome.
Biogen Protocol 105MS401 Plegridy (peginterferon β -1a) Real World Effectiveness and Safety Observational Program (POP).
To assess whether treatment with the selective peroxisome proliferator alpha modulator (SPPARM-a), pemafibrate, will prevent Non-fatal MI, Non-fatal ischemic stroke, Hospitalization for unstable angina requiring unplanned coronary revascularization; or CV death in adults with type 2 diabetes who have elevated triglycerides and low HDL-C, are at high risk for CV events and are on background moderate- or high-intensity lipid lowering therapy or meet LDL-C criteria for lipid control.
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction.
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease.
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease.
Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis.
Entyvio(Vedolizumab) long term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or crohn's disease.
A multicenter, 2 part study to assess the efficacy and safety of H.P. Acthar gel in subjects with Rheumatoid Arthritis with persistently active disease.
Pemafibrate to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes{Prominent}.
A Phase 3, multicenter, randomized, double blind study of a single dose of S03318 compared with placebo or Oseltamivir 75mg twice daily for 5 days in patients with influenza at high risk of influenza complications (Capstone-2).
A randomized, double-blind, placebo-controlled study to evaluate the effect of Praluent on neurocognitive function in patients with heterozygous familial hypercholesterolemia or with non-familial hypercholesterolemia at high and very high cardiovascular risk.
A 6 week, randomized, double blind, placebo and active controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of CHF5259PMDI{Glycopyronium bromide} in subjects with chronic obstructive pulmonary disease(COPD).
A phase 3b, randomized, controlled, multicenter study with oral ferric maltol or intravenous iron(ferric carboxy maltose, FCM), for the treatment of iron deficiency anemia in subjects with inflammatory bowl disease.
A phase 3 randomized, double blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Etrolizumab as an induction and maintenance treatment for patients with moderately to severely active crohn’s disease.
Clinical Study Protocol M15-991, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment.
Clinical Study Protocol M16-006, A Multicenter, Randomized, Double-Blind,Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.
Clinical Study Protocol M16-000, A Multicenter, Randomized, Double-Blind,Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991.
Clinical Study Protocol M14-430, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433.
Clinical Study Protocol M14-431, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy.
Clinical Study Protocol M14-433 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but have not Failed Biologic Therapy.
M14-702-A phase 3 study to evaluate the safety and efficacy of Elagolix in combination with Estradiol/Norethindrone Acetate in subjects with moderate to severe Endometriosis-Associated pain.
M16-283-A phase 3b study to evaluate the safety and efficacy of Elagolix in combination with Estradiol/Norethindrone Acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
M16-837-Phase 2, multicenter, Double-blind (Sponsor unblind), randomized, placebo-controlled study of the safety and efficacy of Elagolix in women with Polycystic Ovary Syndrome.
M16-824-(Low Dose) A phase 3 study to evaluate the safety and efficacy of Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
M12-815-A phase 3 study to evaluate the efficacy and safety of Elagolix in combination with Estradiol/Norethindrone Acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
M12-816- Extension study to evaluate the efficacy and safety of Elagolix in premenopausal women with heavy menstrual bleeding associated with uterine fibroids.
Claims Processing Representative, Home Health & Hospice at Advocate Aurora Health SystemsClaims Processing Representative, Home Health & Hospice at Advocate Aurora Health Systems
Medical Records and Health Information Technician at Guelph General HospitalMedical Records and Health Information Technician at Guelph General Hospital