<p>THIS POSITION IS PAID THROUGH INDUSTRY RESEARCH FUNDING. CONTINUATION OF EMPLOYMENT IS CONTINGENT UPON THE CONTINUED CONTRIBUTIONS AND FINANCIAL SUPPORT OF SCO'S INDUSTRY PARTNERS.</p> <p>Position Overview</p> <p>The incumbent coordinates research studies conducted through SCO's clinical programs and participates with study patients in data collection, follow-up reporting, and communication with study funding sources.</p> <p>Essential Functions</p> <ul> <li>Coordinates with Principal Investigator (PI) to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures. </li><li>Assists the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, and execution of the research plan. Maintains documentation of training. </li><li>Assists PI to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures. </li><li>Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the Director of Research. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate personnel of external audits by FDA and sponsors. </li><li>Collects data in research-related patient eye exams; may perform visual fields, ocular photography, scanning laser topographers/nerve laser topographers/nerve fiber layer analyzers, ultrasonography, biometry, and other tests as needed. </li><li>Attends investigator meetings as required or requested by the PI. </li><li>Prepares study materials as requested by the PI to include, but are not limited to, source documents, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Reports all adverse events to sponsor and IRB. </li><li>Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc). </li><li>Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals. </li><li>Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Ensures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. </li><li>Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol on Investigational Drug/Device Accountability. </li></ul> <p>Completes study documentation and maintains study files in accordance with sponsor requirements, policies, and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.</p> <ul> <li>Assists the PI in submission of accurate and timely closeout documents to applicable federal agencies and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures. Arranges secure storage of study documents that will be maintained according to the contracted length of time. </li><li>Assists PI in the protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and sponsoring agency policies and procedures. </li><li>Assists PI in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with federal regulations and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Maintains documentation of training. </li><li>Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. </li></ul> <p>Job Specifications</p> <p>Education: Bachelor's degree in a related field or equivalent years of experience in a similar role is required.</p> <p>Experience: Experience in medical research is highly desired.</p> <p>Special Skills/Certifications: Certification in Clinical Research preferred (CCRP)</p> <p>SCO does not discriminate on any basis within our educational programs or in our employment practices. Our success as an academic institution requires an ongoing commitment to fostering an accepting and inclusive campus atmosphere because we recognize that each individual deserves to feel included and respected.</p> <p>While hours may vary based on the needs of each clinical study, the typical office hours are Monday-Friday, 8:30-4:30. This is a 35-hour/week position.</p>