Nasreen Sayed, Ms, Ccrp Email & Phone Number

Texas, United States

Indianapolis, Indiana, Us

Diabetes and Weight Management

Durham, North Carolina, Us

◆ Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.◆ Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.◆ Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.◆ Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. ◆ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.◆ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.◆ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.◆ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel/Sponsor training requirements and study specific procedures, plans and training.

Dallas, Texas, Us

◆ Lead research studies in compliance with state and federal protocol requirements, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and standards of Good Laboratory Practice (GLP).◆ Facilitate study initiative visits and pharmaceutical/medical device/CRO monitoring visits. ◆ Establish relationships with key stakeholders. ◆ Mitigate risks to effectively complete study projects.◆ Support and work closely with cross-functional teams to achieve business and study objectives. ◆ Draft case report forms and other study deliverables in a prompt manner. ◆ Facilitate and lead project meetings, manage and execute overall project scope, budget, and timelines. ◆ Develop study-specific protocols, consent forms, and other trial-related materials. ◆ Coordinate and determine project goals, strategy, and schedule to meet research needs. ◆ Manage and conduct research studies across the development lifecycle to meet trial deliverables, set timelines, budgets, and standard clinical trial practices. ◆ Contribute to the planning of clinical trial activities.◆ Engage and cultivate and relationships with key clinicians and serve as the Subject Matter Expert (SME).

Dallas, Texas, Us

◆ Facilitated and conducted training and education for physicians and healthcare staff on clinical trial process. ◆ Drafted and implementing training and marketing project plans. ◆ Forged long-term relationships with study participants and regularly traveled to study participants’ homes to complete assessments.◆ Interviewed, hired, and supervised new employees, interns, and medical students. ◆ Frequently traveled to outpatient clinics and medical practices for marketing purposes.◆ Contributed statistical reports and project milestones for Data Safety Monitoring Board (DSMB) meetings.◆ Completed Institutional Review Board study modifications, continuing reviews & sponsored annual reports. ◆ Improved quality of data collection by internal auditing.

Dallas, Texas, Us

◆ Screened and obtained informed consent and interacted with TBI study patients on a daily/weekly basis.◆ Functioned as primary liaison between client, third party vendors and TBI project team for project issues, including initiating planning, executing, monitoring and controlling and closing out of assigned studies.◆ Wrote and created study protocols/ICF’s.◆ Reviewed site regulatory documents such as CV’s, medical licenses, and financial disclosure forms for study start- ups.◆ Rotated being on-call every four weeks for research studies.◆ Participated in ongoing internal and external meetings as required. ◆ Assisted with in-services for nurses, physicians and other hospital personnel for medical device clinical trial.◆ Operated and recorded data from Moberg device in ICU for Boost clinical trial.◆ Provided patient training with medications and reinforce as applicable.◆ Coordinated and resolved all sponsor related inquiries in a timely manner.◆ Independently performed research, created poster presentations and attended professional meetings.◆ Coordinated and resolved all inquiries and problems associated with data submissions.◆ Processed patients’ blood and cerebral spinal fluid samples per protocol.◆ Communicated with pharmacy to ensure administration of investigational drug to patients. ◆ Managed and maintained the Institutional Review Board paperwork. ◆ Scored neuropsychological tests such as the GOSE, COWA, CVLT, Digit Span, Trails A & B.◆ Created poster presentations and attended American Academy of Neurology Meetings.

Master Of Science (Ms), Applied Cognition & Neuroscience

Bachelor Of Science (Bs), Neuroscience