Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer over 5 years experience in the field of Ophthalmology and 1 and a half years in the field of Clinical Research.
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. Answer phone calls, schedule appointments, verify insurances, whether medical or vision. 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.
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