Clinical Research Coordinator - Ophthalmology

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.

Physical Requirements

% of Time

LBS

Physical Requirements

% of Time

LBS

Bending

10

Vision close/distance

100

Carrying

10

25

Vision color vision

100

Climbing

10

Vision depth perception

100

Driving

10

Vision peripheral vision

100

Grasping

10

Vision ability to adjust focus

100

Hearing

100

Stooping

10

Lifting

10

25

Walking

10

Pulling

10

25

Writing/Typing

100

Pushing

10

25

Speaking

100

Reaching

10