Ehab Hammad Email & Phone Number

Dublin, IE

Morrisville, NC, US

Durham, North Carolina, US

• Perform site selection, initiation and COV in accordance with contracted scope of work and GCP
• Provide visits and site management for a variety of protocols and therapeutic areas.
• Evaluate the study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to PM, CL or Resource Manager (RM).
• Manage progress of studies by tracking regulatory submissions and approvals, recruitment and CRF completion and submission and data query and resolution.
• May provide assistance to less experienced clinical staff.
• Responsibilities include direct contact with assigned clinical sites and uses judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.

• Perform SSV, SIV, IMV and COV.
• Perform 100% SDV of data, verify documentation and timely reporting of ICF, AEs and SAEs, laboratory sample collection and distribution, eCRFs, resolution of queries, investigational product accountability.
• Ensure collection, filing and maintenance of required regulatory documents. Maintaining regular contact and providing support to assigned sites including training.
• Attend Investigator Meetings and/or Study Coordinator Meetings.
• Assist with review data/eCRF completion for quality, query responses/resolution, and timeliness. Provide support to clinical sites.

• Provide subject care and data collection procedures in adherence with the assigned study protocol, good clinical research principles and FDA regulations.
• Ensure Institutional Review Board (IRB) approval of Protocol and Informed Consent Form is obtained prior to initiation of the study.
• Randomize subjects per each protocol via IVRS or IWRS and dispense study drug or study device to appropriate study and protocol.
• Perform follow up visits in the site or over the phone with the adherence to the protocol follow schedule for each visit.
• Maintain accurate records of the receipt, inventory and dispensation of study drug and materials.
• Collect pertinent information and data from subject charts and records, subject interview and other sources. Complete case report forms (CRFs) and electronic case report forms (eCRF) in accordance with research protocol.