The Study Coordinator works independently providing study coordination including screening of potential research participants for protocol eligibility, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, and other research information. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Essential Skills and Abilities: Ability to work effectively and efficiently, must be self-directed and motivated, ability to prioritize and meet deadlines, highly detailed oriented, skills to effectively communicate with patients, family members, medical personnel, sponsors and physician owners.
Essential Computer Applications: Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Coordinate and manage all the daily activities of the study; Ensure study activities follow established protocol.
Perform all physical measurements on study subjects, as well as biospecimen collection and processing; Assure study interventions are completed per protocol; Serve as a liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.;
Recruit, screen, and interview study subjects, ensuring eligibility and understanding of the study; Explain and obtain the informed consent to the subjects; schedule participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Notifies investigators about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
Coordinates training and education of other personnel.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
May identify new research opportunities and present to investigators.
Participates in required training and education programs.
Willingness to work evenings or to vary hours in order to coordinate study visits, juggling of multiple tasks/responsibilities, and good organizational skills.
Education: B.A./B.S. degree (or equivalent combination of education and experience) in Health Sciences or related field; CITI and GCP training a plus.
Experience: Two (2) years minimum experience in Healthcare data management and/or clinical trials required; Ophthalmology background a plus.
ACRP/SoCRA certification required
Phlebotomy certification a plus
Internal Number: CRC1
For over 42 years, Piedmont Eye Center has been a trusted name in eye care in the Central Virginia area. With eight eye care specialists, Piedmont Eye Center is Lynchburg’s largest ophthalmology center. Our doctors use only the latest and best technology to diagnose and treat various eye diseases. Plus, our doctors are local, living in your community, to offer convenient care that fits your busy lifestyle.