The Research Department Supervisor oversees the coordination and management of clinical research studies, ensuring compliance with study protocols, institutional policies, FDA regulations (CFR), and ICH Good Clinical Practice (GCP). This role leads all phases of clinical trials, from design through closeout, and supervises research staff to ensure efficient, compliant operations. The supervisor works closely with Principal Investigators (PIs), central research teams, sponsors, and other stakeholders to support study execution, financial management, and resource allocation. Responsibilities may vary based on study type and departmental needs. The Research Department Supervisor is also a part of the overall Management Team of Sacramento Eye Consultants. In addition to the above, the Research Department Supervisor is expected to step in as a back up to any of the Clinical Research Coordinator roles below when needed. 

Coordinate all clinical research activities.

Expected to Perform all CRC Core responsibilities (as applicable):

· Adhere to an IRB approved protocol

· Participate in the informed consent process of study subjects

· Support the safety of clinical research patients/research participants

· Coordinate protocol related research procedures, study visits, and follow-up care

· Screen, recruit and enroll patients/research participants

· Maintain study source documents

· Report adverse events

· Understand good clinical practice (GCP) and regulatory compliance

· Educate subjects and family on protocol, study intervention, study drug, etc. 

· Comply with Institutional policies, SOPs and guidelines

· Must comply with federal, state and sponsor policies

Also may be responsible for any of the following:

· Manage essential regulatory documents

· Register study on ClinicalTrial.gov (if Physician initiated protocol)

· Complete case report forms (paper & electronic data capture) and address queries

· Submit documents to regulatory authorities (eg. IRB, FDA, etc.) 

· Facilitate pre-study, site qualification, study initiation, and monitoring visits

· Facilitate study close out activities3

· Coordinate research/project team meetings

· Collect, process and ship laboratory specimens

· Schedule subject visits and procedures

· Retain records/archive documents after study close out

Required Skills:

• Effective writing and communication, work as part of a team,      ability to multitask 

· Must complete Good Clinical Practice (GCP) within 30 days of hire or have comparable certification

· Fluent in English – both spoken and written

· Excellent Organizational Skills – able to keep track of multiple projects

· Understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information (including patient, office and sponsor)

· Meticulous attention to detail

· Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately. Added ability working with various software in order to enter data for sponsors (specifics will be trained)

· Basic math knowledge (addition/subtraction/rounding/averaging)

· Trainable/Coachable – works well with others

· Capacity to learn and willingness to ask questions to gain understanding

Desired Skills:

· Ophthalmic Technician experience

· Medical Terminology

· Ophthalmic Terminology

· Experience with assisting/conducting in Pharma/Device Clinical Trials

· Expertise in using Excel

· Fluent in Spanish – both spoken and written

Education & Experience:

· High school diploma required

· 1 year ophthalmology experience required

· 1-2 years ophthalmic technician experience desired

• Effective writing and communication, work as part of a team,      ability to multitask 

· Must complete Good Clinical Practice (GCP) within 30 days of hire or have comparable certification· Fluent in English – both spoken and written· Excellent Organizational Skills – able to keep track of multiple projects· Understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information (including patient, office and sponsor)· Meticulous attention to detail· Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately. Added ability working with various software in order to enter data for sponsors (specifics will be trained)· Basic math knowledge (addition/subtraction/rounding/averaging)· Trainable/Coachable – works well with others· Capacity to learn and willingness to ask questions to gain understanding