FAHEEMA PARVEEN

1) Project Management:

• Assist in the planning, initiation, and execution of clinical research projects.
• Develop project timelines, milestones, and deliverables in collaboration with the project team.
• Monitor project progress and identify potential risks or issues; implement corrective actions as needed.
• Coordinate with various Sponsors/CRO to ensure adherence to project timelines and objectives.

2) Regulatory Compliance:

• Ensure compliance with relevant regulatory guidelines, including ICH-GCP, and NDCT Rules 2019 regulatory requirements.
• Assist in the preparation and submission of regulatory documents, such as study protocols, informed consent forms, and regulatory submissions.
• Maintain up-to-date knowledge of regulatory requirements and communicate changes to the project team.

3) Participant Recruitment and Retention:

• Create strategy for patient recruitment and retention.
• Educate participants about the study protocol, procedures, and informed consent process.

4) Data Management:

• Oversee data collection, entry, and management activities to ensure data integrity and accuracy.

5) Team Leadership and Training:

• Provide guidance and support to clinical research coordinators.
• Oversee the progress of the clinical trial and ensure that the trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), GCP and applicable regulatory requirements.

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
• Participate in site pre-study, initiation, routine monitoring, and study closeout visits in-line with SOPs and Protocols
• Completes case report forms
• Extracts data from patient file (Source documents) in a timely manner
• Schedules study subject appointments and serves as the patient liaison to the PI and other participating physicians
• Monitored patient safety throughout clinical trials and reported any adverse events or serious adverse events.

• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Maintained accurate and up-to-date case report forms and source documents for traceability.
• Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
• Monitored patient safety throughout clinical trials and reported any adverse events.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
• Prepared and maintained regulatory documents for clinical trial submissions.

• Collaborate with principal investigators (PIs) and sponsors to develop study protocols, including participant recruitment strategies, study procedures, and data collection methods.
• Assist in obtaining regulatory approvals (e.g., Institutional Review Board approvals) and ensure compliance with regulatory requirements.
• Identify and screen potential participants according to study eligibility criteria.
• Explain the study protocol, risks, and benefits to potential participants, and obtain informed consent.
• Develop and implement recruitment strategies to ensure adequate participant enrollment.
• Coordinate study visits and procedures, including scheduling participant appointments, conducting study assessments, and collecting study-related data.
• Ensure adherence to the study protocol and compliance with Good Clinical Practice (GCP) guidelines.
• Monitor participant safety throughout the study and promptly report adverse events to the appropriate regulatory authorities.
• Collect, record, and manage study data accurately and in accordance with protocol requirements.
• Maintain study documentation, including case report forms (CRFs), source documents, and regulatory files.
• Ensure data quality and integrity through regular monitoring and verification procedures.

• Assisting the Member Secretary in arranging the meetings, preparing agenda, minutes of meetings and performing of other duties assigned by the Chairperson/Member Secretary
• Documentation and Record Maintenance of all the ongoing clinical trials.