Majid Khan
Germantown,Maryland
Summary
Research professional with proven skills in organizing and managing research studies. Strong background in data collection, analysis, and documentation. Effective collaborator focused on team success and adaptable to evolving project needs. Skilled in participant recruitment, protocol adherence, and maintaining ethical standards. Reliable and results-driven, ensuring high-quality outcomes in complex research environments.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Research Study Coordinator
HolyCross Health
12.2022 - Current
- Coordinates patient care in compliance with protocol requirements. Educates participants regarding medication administration. Maintains individual participant investigational drug accountability.
- Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP).
- Assist in screening potential participants with the delegated investigator for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in the study protocol.
- Supports the review of clinical protocols, informed consent forms, study instructions/manuals/guidelines, department-generated tools, and other study-related clinical documents.
- Coordinates patient care in compliance with protocol requirements. Educates participants regarding medication administration. Maintains individual participant investigational drug accountability.
- In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug and thoroughly documents all findings.
- Ensures the completion and maintenance of consent forms, case report forms, SAE, and source documents to ensure that research is conducted according to guidelines.
- Responsible for accurate and timely data collection, documentation, entry, and reporting.
- Schedules and participates in monitoring and auditing activities.
- Maintains comprehensive knowledge of assigned research protocol to coordinate the compliant execution of assigned protocols per research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
- Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives.
- Maintains regulatory documents per SOPs and applicable regulations.
- Assists in preparing, submitting, and maintaining IRB approval materials.
- Compliance with all federal, state, and professional regulatory standards to provide a safe environment for study participants, caregivers, and study personnel and maintain strict patient confidentiality according to HIPAA regulations and applicable law.
- Act as point of contact for research sites with oversight from the Project Manager.
- Follows the study communication plan for collaboration with research sites.
Lead Clinical Data Manager
Science 37
11.2021 - 11.2022
- Represent Clinical Data Management as a vital member of the Study Management Team for a study, providing training, management, and oversight of all data collection in Science 37’s platform.
- Interact with sponsors, project managers, and all levels of internal staff in highly cross-functional project teams, acting as the lead in designing, implementing, and documenting data collection.
- Responsible for Case Report Forms (CRF), eSource Forms, and database design and build according to Standard Operating Procedures and protocol-specific requirements.
- Perform user acceptance testing on database applications and data transfers.
- Ensure the consistency, accuracy, and integrity of clinical trial data.
- Review, analyze, and validate clinical trial data throughout the study’s lifecycle.
- Query data inconsistencies and address them with an appropriate action plan by revising the case report forms in compliance with standard operating procedures, sponsor, and regulatory guidelines.
- Perform quality control activities: prepare and execute internal database reviews, visual quality control on data transfers.
- Create, review, and maintain project timelines and monitor the progress of data management activities.
- Expertise in developing Data Management deliverables, including Data Transfer Specification (DTS), Data Import Agreement (DIA), Data Management Plan (DMP), Data Validation Specification (DVS), and CRF Completion Guidelines (CCGs).
- Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedures.
- Serve as the clinical data management lead and communicate the status of projects, timelines, changes, and issues to departmental leadership.
- Serve as a resource relative to Clinical Data Management and its support tools, programming and reporting environments.
- Expertise in defining and specifying data collection requirements (such as eCRFs, CRFs, edit checks, and perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database.
- Expertise in writing data management reports and Archival study-related documents in eTMF and overseeing the database lock for an interim analysis.
- Proficient in managing eTransfer’s (ePRO's), eTMF, VEEVA, eConsent and eProtocol.
- Supported the implementation of new technologies and software tools to enhance data management capabilities and streamline workflows.
- Managed the transition to electronic data capture systems, resulting in increased productivity and reduced manual errors.
Clinical Data Manager II
Georgetown University
08.2017 - 10.2021
- Ensured consistency, accuracy, and adherence to ICH regulations, Good Clinical Practice, Good Clinical Data Management Practices, SOPs, and Working instructions.
- Independently managed the cross-functional collaboration, development, and maintenance of the components of the Study Data Management Plan (DMP) and data management deliverables, including the Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, and data quality plan.
- Managed the patient protocol information, reviewed protocols, and incorporated protocol-specific guidelines into the review of clinical data.
- Contributed to the design of the databases and forms, ensuring they meet requirements for entering and reporting clinical data.
- Participated in ongoing data review throughout the study, including the correction of errors and discrepancies management for the life of a project.
- Expertise in supporting end-to-end Data Management related tasks and planning their efficient execution.
- Performed the DM vendor management, including Performance, Budget, Billing, and risk mitigation.
- Processed, tracked, and validated data accurately and on time, following data processing and entry guidelines.
- Experience in vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database.
- Experience in implementing CDISC standards.
- Monitored study progress and the conduct of their respective projects, including all data cleaning and QC activities, to ensure they remained on target with project timelines.
- Coordinated, facilitated, and participated in all data management activities from protocol initiation through database lock with minimal oversight.
Clinical Data Manager I
First Scientific Ltd
05.2014 - 06.2017
- Supported CRF design, review, and validation of clinical databases.
- Performed all aspects of user acceptance testing associated with clinical study databases.
- Created data management plans and other documentation as needed with minimal oversight.
- Proactively identified and addressed issues impacting data quality, deliverables, or timelines.
- Managed the non-CRF data, including lab data and image handling.
- Performed data management study startup activities, including CRF/eCRF design, CRF annotation, developing database specifications, defining validation specifications, and testing the database and validation specifications.
- Ensured all clinical data management documentation was stored and archived promptly and compliant.
- Designed, produced, and distributed standard and customized status, resourcing, and tracking reports and functional area plans to appropriate team members and senior management.
- Managed the interaction with data management vendors to ensure that data management tasks remained on target according to project timelines.
- Proactively organized ongoing data review throughout the study to ensure timely and appropriate identification of errors and discrepancies.
- Facilitated the correction of errors and discrepancies through the site query process, documented permanent data issues, communicated issues with team members, and delivered a quality-locked database for analysis.
Education
Ph.D. - Chemistry
University of York
UK05.2014
M.Sc - Chemical Research
University of London
UK06.2008
Skills
- Experienced in coordinating Phase I–IV clinical trials in compliance with ICH-GCP, FDA, and IRB regulations
- Skilled in patient recruitment, informed consent, and retention strategies, consistently meeting or exceeding enrollment targets
- Proficient in data collection, query resolution, and electronic data capture (EDC) systems such as REDCap, Medidata, and CTMS
- Strong knowledge of protocol adherence, AE/SAE reporting, and regulatory documentation
- Collaborated with sponsors, CROs, and multidisciplinary clinical teams to ensure high-quality trial execution
- Adept at preparing regulatory submissions, source documents, and case report forms (CRFs) with 100% audit readiness
- Skilled in training research staff and mentoring interns on SOPs, study protocols, and compliance standards
- Recognized for maintaining exceptional attention to detail, ensuring data integrity, and supporting successful monitoring visits and audits
- Demonstrated ability to manage multiple concurrent studies, prioritize tasks, and meet strict deadlines
- Strong interpersonal and communication skills with a proven ability to build trust with patients, caregivers, and healthcare professionals
Affiliations
Association of Clinical Research Professionals (ACRP)
Certification
Association of Clinical Research Professionals - Certified Professional (ACRP-CP)
Publications
- Poster presentation "Solution state 15N and 29Si nuclear magnetic resonance from solid-state dynamic nuclear polarization" at a conference, USA, 2007.
- In 2008, I presented a Talk on "Dynamic nuclear polarization and natural abundance 15N nuclear magnetic resonance" at a conference in the USA.
- Poster presentation "Applications of parahydrogen in hyperpolarization" at a Food and Environment Research Agency, UK conference, 2007.
- Poster presentation "Detection of biologically relevant molecules using SABRE" at a FOOD and Environment Research Agency, UK, 2008.
- Presented a Talk titled "Probing the magnetic states of pyridine created by Signal Amplification by Reversible Exchange." Euromar, 2008.
- Presented a poster, "Applications of parahydrogen in the biological field." Euromar, 2007.
- Hyperpolarization through reversible interactions with parahydrogen. Majid Khan, Lyrelle S. Lloyd, Aziz Asghar, Micheal J. Burns, Adrian Charlton, Steven Combes, Simon B. Duckett, Richard J. Lewis, Andrew D. Roberts, and Amy J. Ruddlesden. Catal. Sci. Technol., 2014, 4, 3544 3554.
IT Skills & Personal Attributes
- IT & Conversation: Proficient in Excel, articulate presentation, and excellent searching skills.
- Personal Skills: Problem-solving abilities to overcome significant scientific challenges. Good work ethic and a positive attitude to motivate others. Possesses IT, Management, and communication skills.
- Interest: Attending workshops & seminars to make networks with similar industrial professionals.
- Socialize: Participate in various outdoor activities and develop personal skills through learning.
Timeline
Clinical Research Study Coordinator
HolyCross Health
12.2022 - Current
Lead Clinical Data Manager
Science 37
11.2021 - 11.2022
Clinical Data Manager II
Georgetown University
08.2017 - 10.2021
Clinical Data Manager I
First Scientific Ltd
05.2014 - 06.2017
Ph.D. - Chemistry
University of York
M.Sc - Chemical Research
University of London