Marwa Taha M.Ed Email and Phone Number

Responsible for the successful planning, implementation, and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.·Coordinate site management activities·Develop site/monitoring tools and training materials·Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions·Set and enforce project timelines with the assigned study team·Coordinate remote review of clinical data within EDC system·Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract·Define and implement functional standards, goals, and expectations with clinical monitoring team.·Serve as CRA mentor and perform accompanied field assessment visits as required

·Manages complex clinical research studies in Research Resources Office.·Manages clinical research employees, their activities and workload.·Leads the planning and scheduling activities of direct reports and provides feedback to leadership on study assignments.·Develop and presents training and education on research related procedures.·Manages overall study conduct, by ensuring subject safety is maintained, protocol activities are appropriately carried out, and regulations/GCP practices are followed. ·Responsible for the creation of requires study tools, such as Manual of Operations, source documents, and study orders to insure seamless operations and accurate data collection. ·Oversees reporting and compliance activities.

·Prepare, oversee, and review documents that are related to Investigator Initiated Trials at the Houston Methodist Cancer Center.·Maintain consistency throughout every aspect of the clinical trial, treatment, reporting, data management and staff procedures.·Ensure compliance with all federal, state, and local guidelines regarding clinical trial standard practices.·Monitor and report on the progress of clinical trials. ·Coordinate and lead in the internal feasibility meeting, pre-site visit and site initiation visits.·Lead planning and communication with trial sponsors and research teams to make sure that trials are conducted and executed effectively.·Support investigators and clinical research team with reporting, study auditing, and site visits.·Develop and maintain research protocols, amendments, and procedures.·Coordinate data collection and documentation; queries databases and prepares reports; manages compliance documents.·Prepare and submits annual report, adverse events reporting and audit findings. ·Develop and follow up with Corrective Action Plans and communicate findings to auditors, IRB and research management.

· Responsible for working with specified oncology clinical research teams to conduct ongoing quality assurance reviews of clinical research studies.· Assess audit readiness and develop site specific education and processes to ensure compliance with federal, state laws and The Methodist Hospital Research Institute requirements. · Assist or lead the planning, development and implementation of clinical research training programs and continuing education programs.

· Plans and implements patient, community and staff health education programs and projects. · Manages the research/program agenda and oversees overall operations of multiple research programs.· Assists in grant proposals and submissions.· Monitors the progress of projects and research deliverables, set deadlines, provides supervision and guidance to the research personnel.· Develops cancer materials and resources necessary for program implementation and evaluation. · Develops and conduct training related to research for research personnel and community groups. · Develops and evaluates materials and resources necessary for program implementation and evaluation. · Establishes, cultivates and maintains working relationships and contacts with internal and community constituents, healthcare facilities and other entities to develop and facilitate collaborative partnerships.· Communicates with community and professionals to share objectives and outcomes. · Prepares presentations at professional meetings.

· Provide community outreach, presentations and health education to the participating communities.· Develop and coordinate educational material necessary for program implementation.· Manage and test program material and educational tools for community outreach.· Manage research protocols, and implementation of study components.· Initiate and maintain relationships with internal and external community partners.· Prepare progress reports and presentations.· Train interns and research assistants and provide continuing education opportunities.· Monitor quality control of research data.

· Assist in the creation and management of research protocols, implementation of study components, such as consenting, screening, data collection and assessments.· Oversee, test and develop educational material necessary for community outreach and program implementation.· Maintain relationships with internal and external community partners.· Coordinate health fairs and prepare materials for community outreach and general health promotion and prevention.· Identify and report needed protocol and procedural changes.· Coordinate the ongoing implementation of protocols and defining recruitment and retention strategies. · Maintain confidential study files and records in an organized and secure manner. · Manage data, track and maintain records of recruitment and participation. · Prepare progress reports and presentations. · Supervise interns and trainees on studies and program procedures.

· Recruit, screen and obtain informed consent for research participants.· Encourage community members to participate in clinical and behavioral research studies.· Educate participants through one on one appointments to explain protocols and deliver health education curriculum.· Coordinate and supervise the work of data collectors, and support staff.· Document and maintain records of data and findings.· Develop questionnaires, evaluation and health education material.· Manage, design, and implement research projects and database.· Disseminate and report back to the community about the results of research studies.· Monitor quality control of research data, and accelerometers management and data analysis.

· Develop and implement public health research, community outreach and recruitment.· Recruit participants from various community organizations and events.· Assist in the development and execution of research study.· Organize and coordinate program implementation training for students and interns.· Accelerometers management and data analysis.· Collect, process, and assist in the compilation and verification of research data.· Assist in the development and execution of research studies.· Prepare literature searches, publication material, and overall administrative assistance.· Counseling and youth motivational interviewing, and family health education.· Organize community event, such as health fairs, professional summits and 5K.

· Plan and implement children's social and developmental activities, and prepare lesson plans.· Assist development assessments for children.· Assist the lead teacher in managing the classroom.

- Assists with research projects in Health Disparities office - Completing health assessments and educating participants- Documents and maintains record of data and findings - Accelerometers management and data analysis- Performing a variety of Administrative Tasks- Assist a faculty member with a research project; engage in literature searches- Perform health assessment and patient screenings- Data management and quality control of research data

- Performing eye exams- Assisting in refractive surgeries - Communicating with patients to get detailed health conditions - Pre/post procedures patient education and consenting - Providing emergency care- Conducting low vision evaluations- Contact lens fitting- Examining patients of all ages to detect signs of injury, disease, abnormality or vision defects- Offering advice and reassurance about vision-related matters- Writing referral communications to doctors

- Performing eye exams - Preparing work order for optical laboratory- Working with sales professionals from vision care suppliers- Ensuring that all orders arrive and are to the specifications of the patient- Taking eye and facial measurements- Contact lens fitting and prescriptions - Eyeglasses and Sunglasses fitting & repairing - Guiding patients in selecting frames - Advising patients on any necessary repairs and adjustments

- Assisting with routine data analysis and interpretation using data analysis programs - Following established policies, procedures, and objectives, to improve quality and control standards