Clinical Research Medical
Resume:
Baltimore, MD *****
Phone: 443-***-****
E-mail: *************@*****.***
Dr. Shumaila Rani (MBBS)
Objective: To obtain a Clinical Research Associate position in an environment where I will get a chance to utilize my knowledge and my experience.
Education:
Clinical Research Professional Certification (CCRP) with Certificate No: ho7zg0sqa0 (August 2020) University of Health Science – Pakistan
Major: Master of Research Science (June 2015)
Jiamusi Medical University - China
Major: Bachelor of Medicine and Surgery (June 2012) F.G Degree College – Pakistan
Major: Bachelor of Science – Biology (May 2007)
Research Experience:
Certified Clinical Research Professional Society (CCRPS) 03/2020 – Present
• Maintain the research database in access for all MHS protocols.
• Conduct monitoring visits to ensure the integrity of clinical data with respect to accuracy, accountability, documentation and adherence to procedures through review of CRFs, Source documents, medical records, and regulatory documents
• Conduct all activities according to defined project – specific performance and quality standards, ICH/GCP, SOPs and local requirements.
• Ensure site IRB approval is current and all IRB documentation is in order.
• Conduct retention requirements, drug accountability procedures, serious adverse events (SAEs) reporting procedures and overall management.
• Coordinate the development of protocols, documentation and standard operating procedures for administration and monitoring the clinical trials.
• Monitor compliance of participating physicians with regulatory requirements (FDA, DHHS, and MHS IRB Guidelines).
• Accurately prepare IRB agendas, medical staff committee reports, and ensure that all necessary documents are submitted before established deadlines. Research Medical Officer – Shaukat Khanum Memorial Cancer Hospital & Research Center 04/2015 – 06/2019
• Assumed the role of CRA as assign and performed clinical trial site management activities.
• Remained knowledgeable about applicable regulations, guidelines, diagnostics and clinical trials in general.
• Continued to participate in clinical monitoring training both formal and on the job.
• Monitored assign sites for compliance to protocols and regulations.
• Prepared site visit reports, confirmation letters, follow-up letters and other monitoring documentation as required.
• Performed monitoring visits such as PSSV, SIV, PMV and COV’s.
• Reviewed and verified ICF process documents, study subject data in case report forms (eCRFs) to source documents, resolve data queries, drug accountability, violations and data verifications as required.
• Assisted with tracking patient enrollment, site data, eCRF and ICF as required.
• Facilitated the distribution of study materials and supplies to sites.
• Attended and participated in weekly project team meetings, supporting the project team(s) in development of plans and protocols for studies, designed and reviewed of ICF templates and CRF.
• Contributed site selection materials, site training materials, study data, reports, procedural manuals and other projects – specific documents with the Project Study Team.
• Provided follow–up on deficiencies, maintenance of study files, memos, reports, and documents and coordination of the study.
• Worked on Preparation of tissues, cell cultures, blood samples, etc. for testing.
• Ensured the smooth and efficient day-to-day operation of research and data collection activities.
• Maintained, monitored, and ordered research supplies. Medical Officer – Shaukat Khanum Memorial Cancer Hospital & Research Center 07/2014 – 03/2015
• Ensured the highest standards of patient care for all patients.
• Worked with consultant about the patient’s admission, condition and advised treatment per oncology protocols.
• Carried out investigative and treatment procedures within the Organization.
• Followed- up patients for further plans and treatment.
• Conducted regular ward rounds and ward work at a time that facilitates efficient patient flow and meets treatment objectives.
• Typed patient’s notes, history, and daily progress report in the electronic system.
• Ensured that the team completes discharge summary ideally at the time of discharge.
• Maintained comprehensive and accurate records for all patients seen.
• Established and maintained teamwork and co-operation with the multidisciplinary team. Related Work Experience:
Observership – University of Maryland Hospital – Medical Unit 02/2017 – 03/2017
• Observed both inpatient and outpatient clinical activities
• Attended conference meetings and seminars related to new study.
• Analyzed records, reports and exam data to help them diagnose patients’ conditions.
• Examined and interacted with patients.
Internship and House Job – Aziz Batti Shaheed Hospital 08/2012 - 07/2014
• Performed medical examinations of in and outpatients.
• Diagnosed and made prognosis.
• Prescribed medical treatment based on medical examinations and diagnosis.
• Maintained up-to-date case records and made necessary medical reports.
• Referred patients to professional superiors for more detailed attention, as may appear necessary.
• Communicated patient’s progress to attending physician(s). Skills:
• Research: maintaining medical records, clinical research, clinical trials, conferences, aseptic technique, data collection, electronic data capturing systems, filing, graphs, obtaining vital signs, education and training
• Regulatory: GCP, HIPPA, Data monitoring, quality control and compliance, FDA regulations
• Training: mentoring, process improvement, quality improvement, safety, education and training
• Other: Microsoft Excel, PowerPoint, and Word, Multitasking, creative problem solver, detail-oriented Volunteer Work:
• Attended free medical camps to help and arranged medicines for needy people.
• Presented CPC in Shaukat Khanum Memorial (SKM) on Hodgkin lymphoma during community work.
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