Matthew Casarez

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SIA services and coordination of these projects. May have contact with investigators for submission related activities. Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Achieves PPD’s target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. May develop country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Adhered to standards in areas involving data collection, research protocols and regulatory reporting. Obtained informed consent of research subjects or guardians. Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials. Conducted informed consent presentations and maintained documentation. Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants. Kept patient care protocols and clinical trial operations in compliance. Organized, analyzed and modeled study data. Collected, processed and delivered specimens from trial. Assessed drug storage conditions and procedures to check adherence to standard protocols. Tracked study-specific trial management tools and systems. Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board. Attended necessary meetings, that include investigator meetings, pre site selections visits, site initiation visits, etc.

Obtain subject informed consent according to federal regulations, GCPs and IRB requirements. Clearly and concisely document subject assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs. Recruit qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines. Schedule and conduct subject visits according to protocol requirements and timelines. Maintain accurate and complete written source documentation of subject visits and protocol related activities. Accurately complete case report forms and/or worksheets generated by the sponsor. Maintain confidentiality of patient and protocol issues as appropriate by HIPAA regulations. Promptly report adverse events to supervisor Principal Investigator/Sub-Investigator as deemed necessary. Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to supervisor, Principal Investigator and/or Sub-Investigator. 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. Maintain ongoing communication with Principal Investigator, Sub-Investigators, and other persons assisting with the trial and documents these communications according to protocol requirements. Attend Investigator Meetings and/or other trainings as directed. Perform all study-related duties in a time and cost-effective manner.

Obtaining informed consent per ICH/GCP and site SOP’s. Interviewing and collecting data from the study participants. Recruited volunteers for studies through database search and through investigator recommendations. Scheduling subject visits according to clinical protocol and study protocol. Obtaining subject vital statistics. Dispensing/collection study medications per protocol and providing accurate investigation product accountability. Collecting subject laboratory specimens according to protocol, processing, and shipping per IATA guidelines with IATA certification. Completing case report forms and other patient tracking information accurately and on a timely basis as assigned and required by Sponsor. Maintaining a thorough understanding of all data collection instruments. Collecting data accurately and maintains strict adherence to protocols. Ensuring IP is maintained under temperature control per protocol. Performs lead, backup and unmasked coordinator duties as designated.

Scribed for Dr. Richard Evans, Dr. Michael Singer and Dr. Angela Rowden. Assisting with and recording comprehensive and intermediate exams electronically through Integrity EMR system. Sending patients medications to their pharmacy. Assisting with minor procedures such as Chalazion excision, Lid Lesion removal, SLT(Selective Laser Trabeculoplasty, LPI(Laser peripheral iridotomy), YAG Capsulotomy, Blepharoplasty(upper and lower), Ptosis repair, cosmetic injections and intravitreal injections for Macular degeneration, diabetic macular edema, etc. Worked up patients and collected medical history, past procedures, current medications, allergens, family history, and any other information needed by the doctors. Performed special tests such as Visual Fields, OCT's of the macula and optic nerve, Optomap Fundus photography, VEP/ERG and LipiView. Maintained a professional and welcoming attitude, and provided the best patient care possible.

Run pre-screening tests for patients including visual acuity, auto refraction, visual field, OptoMap, OCT, Clearpath and more. Gathered patients information including both systemic and ocular medical history, family medical history, current medications, allergens, chief complaints, and more. Taught patients the correct way to insert and remove contact lenses, along with offering tips and advice for treating and handling lenses.