Clinical Trials Coordinator

I. Position Summary:

The Clinical Trials Coordinator responsibilities are performed under general supervision and consist of mid-level research Coordinator duties that require a firm understanding of Clinical research concepts, guidelines, principles and practices; tasks require a high level of organizational skills and the exercise of discretion and ability to ask the right questions to determine proper course of action while following established protocols.

He/she monitors eligible patients enrolled in research protocols in accordance with FDA required Good Clinical Practice. Adheres to National Patient Safety Goals as appropriate based on the level of patient contact this position requires.

II. Essential Functions:

Data Entry / Management (including, but not limited to the following):

* Performs data collection/completion

* Maintains research records including source documents, case report forms, and system EMR.

* Tracks and maintains the quality and integrity of all research documents.

* Prepares documents for submission to the appropriate IRB and new protocol submissions, amendments, revisions, status changes, continuing reviews, expedited reviews and informational items.

* Prepares for and participates in sponsor monitoring visits, study initiation visits, and closeout visits.

Clinical / Patient Involvement (including, but not limited to the following):

* Identifies patients for clinical studies.

Means include but are not limited to: chart reviews, physical assessments, advertising, health fairs, media outlets and phone

* Screening to determine study eligibility and enrolls appropriate patients in clinical studies to meet contractual goals

* Responsible for specific clinical research studies as assigned by the Clinical Research Manager. It includes the identification, consent process, randomization, administration of study drugs, monitoring of eligible patients enrolled in research protocols in accordance with FDA required Good Clinical Practices.

* Responsible for initiation, organization and carrying out of patient follow-up. Assess patients and analyzes patient data at follow-up visits.

* Collects data as required by the study protocol including vital signs, ECGs, phlebotomy, and lab processing.

* Administers drugs according to protocol and inventories study drug to maintain drug accountability.

Administrative/Regulatory (including, but not limited to the following):

*Conducts research testing and acts as immediate resource between clinical and study Sponsor staff.

*Attends various meetings pertaining to research projects and DMEI research program overall; may present information.

*Assumes lead role to ensure adherence to protocol while coordinating the work of research team personnel

*Assumes lead role pertaining to Monitoring visits conducted by IRB, study Sponsor, etc.

*Knowledge of pre/post project requirements and federal guidelines.

Other Duties

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

III. Accountability:

(Reports to and accountable for)

The Clinical Trials Coordinator reports to the Clinical Research Manager for Dean McGee Eye Institute.

IV. Qualifications:

(Minimum education, training and experience, licensure, certification)

* Bachelor’s Degree in Healthcare Administration, Business OR an equivalent combination of education and/ or experience which comparable knowledge, skills and abilities have been achieved.

* Ophthalmology experience or Research experience preferred; or otherwise approved by Clinical Research Manager

* Knowledge of medical terminology

* Proficiency with computer systems and Microsoft Office (Outlook, Word, PowerPoint and Excel) required.

* Must be able to communicate effectively in English (Verbal/Written).

* Oklahoma State Driver’s License as well as a driving record which is acceptable to our insurance carrier.

Preferred

*36 months of research program coordination experience OR

*24 months of ophthalmology experience, plus COT or COMT certification

V. Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Strength (Lift/Carry/Push/Pull): Light (Exerting up to 20 pounds of force occasionally or up to 10 pounds of force frequently)

Standing/Walking: Frequently; activity exists 1/3 to 2/3 of the time

Keyboarding/Dexterity: Constantly; activity exists 2/3 or more of the time

Talking (Must be able to effectively communicate verbally): Yes

Seeing: Yes

Hearing: Yes

Color Acuity (Must be able to distinguish and identify colors): Yes

VI. Environmental Conditions:

Exposed to variations in volume, location and timing of work.

Able to respond to a variety of demands and expectations from staff, physicians, patients and families.

Exposure to high stress caused by a need to meet a variety of deadlines and priorities with frequent interruptions from phone calls and co‑workers. Exposure to automobile traffic and weather conditions when driving to and from doctor offices. Most travel is conducted between high volume times of day. Hazards are minimal if safety precautions are utilized.

Work involves potential exposure to infectious waste, hazardous materials, exertion and musculoskeletal injury. May be exposed to cleaning solvents.

This position may have additional or varied physical demand. Please Human Resources for additional information.

All applicants will receive consideration regardless of membership in any protected status as defined by applicable state or federal law, including protected veteran or disability status.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.