Daniel Stokes

● Interacting with staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physician’s offices

● Read, understand and specified protocols for patient visits and procedures through schedule of activities and CRF guidelines

● Obtain patient informed consent with current versions

● Obtain medical history, concomitant medications, surgeries, hospitalization and any procedures needed to qualify patient for protocol requirement such as ECG, vitals, bloodwork and outside venders

● Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary

● Account for clinical trial materials (i.e. CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study

● Attend Investigator Meetings, P/SIV’s, monitor visits, site calls as directed either on site or travel

● Perform all study-related duties in a timely manner

● Maintain and complete IP accountability and drug confirmation for all study drugs that are shipped to site

● Clean and prep unblinded/blinded pharmacy rooms

● Dose patients with proper IP that is verified by IWRS/IRT system either through a subcutaneous, intramuscular or oral route

● Contact CRA’s with questions, concerns or updates regarding study requirements or needed supplies regularly

● Upload updated IRB documents into CTMS system

● Upload regulatory documents required for site

● Send out lab results for signature to PI’s to confirm subject eligibility

● Have weekly meetings with PI to discuss subject eligibility for randomization

● Request, edit and revise eSource for studies based on guidelines, manuals, ICF and protocol

● Schedule future appointments and assist with recruitment calls when needed

● Document protocol deviations and help assist with QC when needed

● Responsible for submission of subject payments, if needed transportation assistance

● Ensure ICF, esource and protocol reviews are completed properly to ICH GCP standards before final version is submitted for approval

• Assist in planning and implementation of pharmaceutical research studies, including the recruitment and enrollment of patients for research studies as well as the development and management of databases related to research studies
• Provide sickle cell education to participants and collaborate with other medical services
• Manage full range of patient and protocol assessments, including safety and efficacy
• Create and complete source documents and collaborate with team members to implement program policies and procedures.
• Coordinated investigator meetings, conference calls, and site initiation visits as needed.
• Collected, processed and delivered specimens from trial participants.
• Conducted screening interviews to determine eligibility of possible subjects.
• Performed patient assessments, collected and analyzed data, and prepared reports.
• Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .

• Coordinated and supervised Sickle Cell Trait Screening to the DC Metropolitan community.

• Shadowed and assisted numerous surgeries and office hours under an Orthopedic Surgeon
• Obtained experience with medical charting and history, dictation, injections, interpreting x-rays, and other medical tasks.