Muhammad Naeem Shaikh

Monitor Investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records / clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Responds to company client and federal regulatory requirements / audits.

Perform monitoring visits and site management for a variety of protocols, sites and therapeutic areas Administer protocol and study related training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and Line Manager Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report forms (CRF) completion and submission, and data query generation and resolution Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation

Implements and monitors Clinical Trials to ensure Sponsor and Investigator obligations are being met and compliant with applicable local regulatory requirements and ICH-GCP guidelines Reviews and verify accuracy of clinical trial data collected, either onsite or remotely Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites Performs source document verification and query resolution as per study requirements Performs essential document site file reconciliation Assesses IP accountability, dispensation and compliance at the investigative sites Updates applicable tracking systems (CTMS, eTMF) Communicates with investigative sites

Coordinated support from hospital departments to conduct clinical trials at CMC in collaboration with UCSF Fresno researchers Facilitated in writing reports on hospital resource utilization related to Research procedures Supported the coordination of conduct of Research studies to ensure adherence to Good Clinical Practice Guidelines, State and Federal regulations and institutional policies and procedures Provided assistance in Community Medical Center (CMC) research billing process

Assisted Investigators in screening patients for potential COG study enrollment, scheduled patients for study visits as per the study protocol, developed source documents, extrapolated data and completed electronic data submission Participated in the Human Subject Committee meetings and revision of consent when reviewing Oncology and Hematology protocols to assure that all Government regulations (IRB) and compliance issues (COG and NCI) were met within these studies for the Protection of Human Subjects

Involved in CDC sponsored study. Obtained Informed Consent from patients Performed study procedures including screening, interview, and blood draw, nose and throat swab and sputum for culture Participated in Chart reviews and data entry

Collected urine samples from predominantly male patients, for detection of bladder cancer, prepared slides for examination Compared the results of abnormal chromosomes in urine cells with Cytology results Collected data and summarized the results Participated in team meetings