Job Profile Summary

Job Overview

This position assists in planning and implementing clinical research studies as assigned. Works directly with patients and their families providing a wide range of state-of-the-art imaging. Performs a variety of screening and technical diagnostic tests and facilitates all implementation phases of new studies and the ongoing coordination and maintenance of open and closed studies. The position arranges and coordinates all clinical trial activities and plays a key role in assisting the Principal Investigators in recruiting and overall coordination of patients for clinical studies. Supports and provides guidance on the administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies.

Job Description

Minimum Qualifications:

1. High school diploma or equivalent.

2. Two (2) years of experience in research-related activities.

Preferred Qualifications:

1. Bachelor’s degree in a research-related field.

2. Five (5) years of experience in research-related activities.

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Assists in the recruitment of study participants.

2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.

3. Completes follow up with study participants in prescribed settings as required.

4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.

5. Complies with all institutional policies and government regulations pertaining to human subjects' protections.

6. Reviews protocol with the clinical team and ensures clinical team is aware of their roles and responsibilities.

7. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location.

9. Identifies and resolves problems with protocol compliance by notifying investigator and the protocol sponsor as necessary.

10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.

11. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

12. Maintains inventory of all study supplies.

13. Responsible for maintenance of equipment certifications for clinical trials.

14. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.

15. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.

16. Reviews all eligibility and ineligibility criteria in the patient's record.

17. Verifies information with the physician.

18. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.

19. Maintains regulatory binders, case report forms, source documents, and other study documents.

Physical Requirements:

1. Ability to physically assist patients from wheelchairs into exam chairs.

2. Ability to escort patients to other floors within the department as needed.

3. Ability to assist the elderly and visually impaired.

4. Requires prolonged standing, walking, some bending, stooping, and stretching.

5. Close contact with children, adolescents, elderly, and sensory handicapped patients, with some exposure to blood and hypodermic needles.

Skills & Abilities:

1. Excellent interpersonal skills necessary to work effectively with patients, understand their needs, and be responsive to the elderly and sensory handicapped.

2. Ability to work closely and effectively with physicians and other clinical staff, including residents, fellows, attending physicians, and nurses.

3. Basic knowledge of anatomy and physiology.

4. High degree of detail, organizational talents, data collection, and analysis skills.

5. Strong computer/graphic skills.

6. Ability of priority quickly and appropriately

7. Excellent communication skills required for effectively explaining the exam process to patients and attempting to allay their concerns and apprehensions.

8. Demonstrates knowledge and skills necessary to assess the needs of patients of different age populations in order to provide care appropriately.

9. Energetic, self-motivated, and ability to work in a fast-paced environment.

10. Demonstrates proficiency with or a learning-knowledge in use of the technician requirements.

11. Knowledge of or aptitude for biological sciences.