Ensures the validity of clinical trials by providing timely and accurate data entry under the direction and guidance of the Principal Investigator, Department Director, and clinical research protocols of Health Outcomes Centers (HOC).

DUTIES AND RESPONSIBILITIES:

1. Establishes, manages and maintains a record-keeping system to insure adequate documentation of each clinical protocol is in accordance with IRB requirements. Manage and ensure records are audit ready and available upon request. Maintain all regulatory binders in compliance with IRB regulations and sponsor requirements.

2. Manage with sourcing, enrolling, scheduling, and evaluating patient response to study criteria. Assist with the day-to-day operations of the front and back office. Assists in the coordination of referrals, scheduling and patient communication.

3. Enters, verifies, analyze and validates data within 48 hours per study protocol and sponsor requirements.

4. Communicate with patients and send patients to labs if applicable. Conducts customer outreach calls regarding compliance and routine matters in accordance with the patient management program. Communicate with providers on patient updates.

5. Coordinates with Pharmacy on monitoring inventory and reconciling medications with patients. Coordinate with Pharmacy to follow up with insurance companies in a timely manner regarding prior authorizations and billing.

6. Analyze and consolidate patient data using case report forms (CRFs). Recall patients every 6 months and gather data regarding changes in medical status and medication compliance.

7. Manage, analyze and present study data as required. Review and answer queries regarding case report forms (CRFs) within a timely fashion.

8. Prepare for next day clinic by identifying appointment types and chart preparation. Updates pre-registering patients and screening patients for program eligibility.

9. Manage patient enrollment and report daily changes to Lead Clinician. Notify Lead Clinician of any issues or with study sites or with patients.

10. Provide exceptional customer service internally and externally. Greets each customer with appropriate introduction. Address concerns prior to end of interaction. Assists with other departments as needed.

11. Performs other related duties as assigned.

JOB QUALIFICATIONS:

High school diploma or equivalent required

Experience with EMR/EHR preferred

Data entry and database maintenance experience required

Bilingual in English and Spanish preferred

Knowledge of research design pertaining to clinical trials preferred

Knowledgeable of personal computers

Knowledge of database entry preferred

Scheduled hours and/or work locations are subject to change

PHYSICAL ACTIVITIES AND REQUIREMENTS:

Finger Dexterity: Using fingers to make small movements such as typing or picking up small objects.

Talking: Frequently conveying detailed or important instructions or ideas accurately, clearly, or quickly.

Hearing: Able to hear average or normal conversations and receive ordinary information.

Repetitive Motions: Frequently and regularly using the wrists, hands, and fingers.

Visual: Average, ordinary, visual acuity necessary to prepare or inspect documents or other materials.

Physical: Sedentary work; sitting most of the time. May have to lift folders, files, papers, audio/video equipment, and other such items weighing up to approximately 25 lbs.

Education

• High School/GED or better in General Business