Description

SUMMARY

Oversees details of studies. Ensures compliance with study review board and monitors.

Demonstrates quality patient service during interactions with patients, coworkers, and vendors:

• Exhibits a positive attitude and is flexible in accepting work assignments and priorities
• Meets attendance and tardiness expectations
• Is dependable; follows policies and procedures
• Maintains professionalism in interactions with patients and coworkers
• Performs quality work and consistently exhibits initiative

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Evaluate protocols; assist in study selection; correspond/coordinate with the sponsor/CRO; prepare study budgets.
• Prepare/manage site for clinical research studies, create study-specific source document binders for each subject including appointment calendar for study visits and enrollment logs; prepare for monitor visits including initiation, interim, and close-out visits; create protocols for Investigator Initiated Trials.
• Conduct in-services for study staff, review GCP guidelines, maintain GCP &/or CITI certification; obtain/maintain study-specific examiner certification as required by protocol for participating study staff; attend study coordinator meetings. Conduct in-services for study staff, appointment/surgery schedulers, and surgery staff, etc.
• Participate in subject recruitment, advertising, patient education/subject consent process, enrollment process, & follow-up visits.
• Maintain regulatory documents including those items required for study site, sponsor, and IRB for initiation, interim reports, and close-out documentation.
• Conduct clinical research as outlined in the study protocol; maintain knowledge of clinical research issues; follow GCP guidelines; implement confidentiality and privacy regulations.
• Perform study-specific testing/exams, administer questionnaires/surveys per protocol guidelines; document medical/ocular health.
• Complete study source documentation; complete/submit case report forms via courier service, fax, or electronic data capture; dispense/collect study drug/device as outlined in the study protocol; maintain study supplies, study drug/device accountability logs, and calibration logs.
• Assist in classifying and reporting Adverse Events and Serious Adverse Events to sponsor and IRB; manage follow-up care; report relevant events and/or resolution.
• Coordinate financial agreements, study budgets, and subject stipends with financial officer and sponsor.
• Other duties as assigned.

JOB QUALIFICATIONS To perform the job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily with or without reasonable accommodation. The requirements below are representative of the minimum knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties and responsibilities.

EDUCATION AND/OR EXPERIENCE

• Position requires at least high school graduate. College grad preferred.
• Position also requires CCRC or higher.
• A strong working knowledge of ocular anatomy and common diseases and conditions typically obtained by having at least 1 year of ophthalmic or optometric experience is required.
• Must have at least 1 year of ophthalmic technician experience typically acquired through working in an ophthalmic or optometric office.
• This position requires an organized, inquisitive and detail oriented individual who is proficient in spreadsheet and word processing software.
• Being comfortable working in a team environment, being open to working in varying roles and traveling to various locations is required.

CERTIFICATES, LICENSES, REGISTRATIONS

• Position also requires CCRC or higher.

PHYSICAL DEMANDS

Indicate the amount of time spent for each activity required as it relates to the essential functions.

Location: Work takes place in a normal office environment. Travel to other CVP locations may be necessary to fulfill essential duties and responsibilities of the job. Thus, those needing to travel for work must have access to dependable transportation, and driving record must meet company liability carrier standards.

Exposure: Works in normal office environment during normal business hours. May be exposed to blood or bodily fluids. May also be exposed to various cleaning supplies.

Equipment: The equipment typically used in this position is a computer, fax, copier, printer, scanner and telephone. Must have good working knowledge of Word, Excel and Access. Other equipment may be used as needed. Personal Protective Equipment (PPE) follows standard precautions using personal protective equipment.

DISCLAIMER

This job description is intended to convey information essential to understanding the current scope of the job and the general nature and level of work performed by current job holder(s) within this job. This job description is not intended to be an exhaustive list of qualifications, skills, efforts, duties, responsibilities or working conditions associated with the position. CVP reserves the right to change the expectations of the job and assign or reassign duties and responsibilities at any time.