Trial Management Clinical Research

Dr Asma Khan. MBBS, MS.

Graduate Research and Teaching Assistant UNC, Charlotte

*************@*****.***. Mobile:+1-980-***-****

**** ********** **** ****, ********* NC 28223.

Career Profile:

Experienced clinician with a strong background in patient-facing roles within large-scale inpatient and academic settings. Over 4 years of research expertise supporting multi-site, CRO-run clinical trials. Seeking to leverage clinical and research experience in a specialized trial management position, focusing on ensuring high standards of trial execution, compliance, and patient outcomes.

Relevant work experience:

Trial Management Intern

Repare Therapeutics, Cambridge MA May 2023 – Dec 2023

Assist in collecting, organizing, and maintaining clinical trial data.

Input and manage data in electronic databases.

Assist in preparing and organizing essential study documents, including consent forms, regulatory binders, and patient records.

Help schedule patient visits and follow-ups as required by the study protocol.

Support patient enrollment by explaining the study to potential participants under supervision.

Assist in analyzing data under the guidance of senior researchers or data analysts.

Support the creation of reports and presentations for team meetings or external stakeholders.

Research Analyst 2020-2021

HCG Oncology research center, India

Data collection from trial participants, data entry into custom developed databases.

Data management, cleaning and processing.

Statistical testing of data using research framework question, hypothesis testing

Data visualization, analysis and interpretation.

Ensure secure handling and storage of participant data as per ethics requirements and institutional policies.

Clinical Research Assistant 2018-2020

Cancer Research Institute, India.

Submitted ethics applications and amendments for the clinical trial project.

Participant recruitment, conscenting, onboarding, etc for a sample of 500 patients.

Performed participant assessments, drawn labs, routine follow ups, recorded vitals, and assessment findings, etc. for a 12-month longitudinal study.

Maintained communication with study participants, addressed concerns, recorded drop outs, developed monthly anonymous summary reports for the investigators, etc.

Provided participant with education and safe handling techniques.

Education

Master’s in Health Informatics and Analytics, UNC Charlotte Graduated May 2024

Bachelor of Medicine, Bachelor of Surgery (M.B.B.S)

Certifications and Honors

Healthcare data quality and Governance- UC Davis

Data or Specimen only research(IRB)- CITI Program

Good Clinical Practices(GCP)- CITI Program

Phi Kappa Phi Honor- Phi Kappa Phi Honor Society

Relevant Skills

Clinical Research: Protocol compliance, data accuracy verification, site monitoring, regulatory requirements

Technical Skills: SQL, Tableau, Python, SAS, Microsoft Office Suite (Word, Excel, PowerPoint)

Data Management: REDCap, electronic data capture (EDC) systems, clinical trial management systems (CTMS)

Soft Skills: Strong organizational and time management skills, excellent written and verbal communication, attention to detail, team collaboration.

Clinical Skills

History and physicals

General physical and systemic examination

Drawing labs

Additional Experience

Experienced in working with diverse patient populations in oncology, nephrology, and cardiology.

Proven leadership and project management skills with a focus on timely delivery of high-quality results within budget.

Extensive knowledge of FDA and IVDR regulatory requirements for clinical research.

Professional Development

Active participation in clinical research and health informatics conferences.

Continuous learning and certification efforts in clinical research and healthcare data analytics.

References available on request.

Contact this candidate