Clinical Research Associate

SOOFIA MASOOD

********@*****.*** • 630-***-****

EDUCATION

Dow Medical University Bachelor of Medicine, Bachelor of Surgery

St. Joseph’s College Associate of Science

EXPERIENCE

HCRA Clinical – Clinical Research Associate [unblinded and blinded lead], Houston, TX Jul 2022 – Current

• Lead team of 2 clinical research associate

• Read and comprehend assigned research protocols.

• Conduct prescreening of potential patients

• Conduct meetings with CRAs and keep everything up to protocol

• Use the Electronic Medical Record (EMR) to screen eligible patients.

• Facilitate patient qualification discussions with the Principal Investigator.

• Report Adverse and Serious Adverse Events to IRB and Sponsor following guidelines.

• Obtain and document informed consent following ICH/GCP and site SOPs.

• Ensure timely and accurate data entry based on the ALCOA principle.

• Organize and collect all source data in the electronic source system.

• Address and close any queries from prior visits.

• Receive, check, and keep medication in proper storage facility with proper temperature making sure that accountability logs are readily available.

• Dispense medication to participant maintaining the blind after eligibility was done by the PI with accurate Investigational Product accountability.

• Audit inventory of medication making sure supplies are enough for all participants and order more whenever needed

• Maintain records in the IRT (software to keep track of study information)

• Took part in 9 different studies and got familiarized with each study protocol and trained colleagues on said protocols

also Record attendance during training sessions.

Whenever a new version of a Protocol is released, conduct trainings of the colleagues accordingly.

• Conduct QC of all the unblinded and blinded documents

• Plan subject visits as per protocol-specific schedules.

• Prevent protocol deviations related to out-of-window procedures.

• Coordinate with location administration to ensure space and resource availability.

• Complete case report forms (CRFs) and other patient tracking information accurately and promptly.

• Maintain a comprehensive understanding of all data collection instruments and ensured accurate data collection according to the protocol.

DM Clinical Research – Clinical Research Associate [unblinded and blinded lead], Houston, TX Jan 2019 – Dec 2021

• Lead team of 4 clinical research associates

• Conducted meetings with CRAs and kept everything up to protocol

Enrollment Management:

• Used the Electronic Medical Record (EMR) to screen eligible patients.

• Facilitated patient qualification discussions with the Principal Investigator.

• Reported Adverse and Serious Adverse Events to IRB and Sponsor following guidelines.

• Obtained and documented informed consent following ICH/GCP and site SOPs.

• Ensured timely and accurate data entry based on the ALCOA principle.

• Organized and collected all source data in the electronic source system.

• Addressed and closed any queries from prior visits.

• Prepared and passed FDA audit on testing facility for study with 429 participants

• Received, checked, and kept medication in proper storage facility with proper temperature making sure that accountability logs are readily available.

• Dispensed medication to participant maintaining the blind after eligibility was done by the PI with accurate Investigational Product accountability.

• Audited inventory of medication making sure supplies are enough for all participants and ordered more whenever needed

• Maintained records in the IRT (software to keep track of study information)

• Took part in 31 different studies and got familiarized with each study protocol and trained colleagues on said protocols

• Whenever a new version of a Protocol was released, conducted trainings of the colleagues accordingly.

• Conducted QC of all the unblinded and blinded documents

• Planned subject visits as per protocol-specific schedules.

• Prevented protocol deviations related to out-of-window procedures.

• Coordinated with location administration to ensure space and resource availability.

• Completed case report forms (CRFs) and other patient tracking information accurately and promptly.

• Maintained a comprehensive understanding of all data collection instruments and ensured accurate data collection according to the protocol.

DM Clinical Research – Quality Control Specialist, Houston TX Aug 2018 – Jan 2019

• Quality control lead for multiple studies

• Fact checked ICF (Informed Consent Form) by making sure signatures, dates, patient information etc. was accurate

• Carried out GDP (Good Documentation Practice) by following ALCOAC and making sure data integrity was not compromised.

• Also carried out GCP (Good Clinical Practice) and SOP (Standard of procedures)

• Making sure not to obsolete the original data whenever a correction was made in the study documents.

• Making sure entries on study documents and any changes were made by study team members with the authority to do so, as delegated by the PI (DOA)

• All the OOW (out-of- window visits) must have a progress notes indicating clear reason for the delayed visit.

• Any SAE and AE should be notified to the IRB after consulting with the PI depending on the severity of the condition.

Loyola University Medical Center – Research Associate; Maywood, IL 2008 – 2013

• Performed methods for coagulation and platelet function testing while carrying out other analytical techniques such as ELISA based assays for the surrogate markers of inflammation and thrombotic activation

• Worked on two articles based on the research work in the following areas:

o Role of inflammatory mediators in DIC.

o Cancer and thrombosis. Role of micro particles

o Variations in the anti-coagulant responses in various pathologic states.

• Invited to present work in the 4th meeting of the German Society of Thrombosis in St. Galen Switzerland in February 2012

Medicon Hospital – Primary Care Physician; Karachi, PK 1996

CERTIFICATIONS

• CITI GCP Certificate

• IATA Certificate

• NIH Certificate

• USMLE STEP 3

• USMLE STEP 2 CS

• USMLE STEP 2 CK

• USMLE STEP 1

ADDITIONAL INFORMATION

Computer Skills: MS Office, Excel, PowerPoint, Impala, Florence, Crio, IMedidata, FireCrest, EndPoint, IRT, SIP, Inform

Languages: Fluent in English and Urdu

Work Eligibility: Eligible to work in the U.S. with no restrictions

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