Clinical Research Technician

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 facilitat es 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 DUTIES AND ESSENTIAL FUNCTIONS :

• Demonstrates proficient use of the following research duties and functions :
• Responsible for assisting in the recruitment of study participants.
• Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
• Reviews all eligibility and ineligibility criteria in the patient’s record.
• Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
• Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.
• Completes follow up with study participants in prescribed settings as required. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.
• Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.

Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries.

Completing data entry as warranted.

• Performs basic laboratory activities as needed
• Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents.

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

• Reviews protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.
• 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.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adhere to FDA Good Clinical Practice Guidelines.
• Identifies and resolves problems with protocol compliance by notifying investigator and the protocol sponsor as necessary.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation
• Maintains inventory of all study supplies
• Certifies and participates in all current clinical trials for all ophthalmic specialties
• Certifications expected within 6 months of hire
• Submits images to reading centers and keeps archives of submission data.
• Responsible for maintenance of equipment certifications for clinical trials.

JOB REQUIREMENTS :

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.

JOB KNOWLEDGE AND SKILLS :

1) Experience in an ophthalmic or healthcare related setting

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

Also requires the ability to work closely and effectively with physicians and other clinical staff, including residents, fellows, attending physicians, and nurses.

3) Knowledge of eye terminology, basic anatomy and physiology of eye preferred.

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) Knowledge of or aptitude for biological sciences preferred.

8) Proficiency and ability to work independently in all areas and provide smooth patient flow.

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

10) Must demonstrate knowledge and skills necessary to assess the needs of patients of different age populations in order to provide care appropriately.

11) Knowledge of laser software and laser safety, where applicable.

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

13) Bilingual in Cantonese, Mandarin, or Russian preferred.

14) Current CPR certification preferred.

LICENSES, ETC. :

If you do not have, you may be required to obtain once hired.

• BLC certification
• IATA Hazardous Good Shipping Certification
• CITI Human Research Protection Certification
• CRA and / or OCT-C Certification
• COA Certification

PHYSICAL REQUIREMENTS :

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

2) Ability to escort patient 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.

WORKING CONDITIONS

1) Typical clinical and administrative office setting

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

3) Busy multi-specialty practice, and work environment involving several physicians.

4) Must be able to perform all essential functions of this position with reasonable accommodation if disabled

5) May access PHI / HIPAA identifier as part of daily tasks