Clinical Research Coordinator I - Ophthalmology

Tufts Medicine; Boston (MA); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player in clinical research is seeking a dedicated Clinical Research Assistant to support various ophthalmology studies. In this role, you will assist in participant recruitment, manage study documentation, and ensure compliance with institutional and regulatory guidelines. Your meticulous attention to detail and strong organizational skills will be essential as you handle data collection and analysis. This position offers a unique opportunity to contribute to innovative research that enhances vision care, all within a collaborative and supportive environment. If you are passionate about clinical research and eager to make a difference, this role is for you.

Qualifications

• Bachelor's degree or equivalent experience required.
• BLS certification may be required based on role.

Responsibilities

• Assist in recruiting study participants and follow up as needed.
• Maintain regulatory compliance and monitor clinical adverse events.
• Perform basic laboratory activities and maintain study supplies.

Skills

Organizational Skills

Data Collection and Analysis

Attention to Detail

Computer Skills

Communication Skills

Interpersonal Skills

Record-Keeping

Education

Bachelor's Degree

High School Diploma

Tools

Basic Life Support (BLS)

IATA Hazardous Good Shipping certification

CITI Human Research Protection certification

Job description

Job Overview

The Department of Ophthalmology boasts a robust and well-established clinical research portfolio, actively engaged in a variety of industry-sponsored and federally-funded Phase II and III trials. Our focus spans both innovative treatments and cutting-edge imaging technologies. Aligned with our mission to preserve and enhance vision, our clinical research efforts support all specialties within Ophthalmology, with a primary emphasis on Anterior Segment, Posterior Segment, and Pediatric Ophthalmology.

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.

Job Description

Minimum Qualifications:

1. Bachelor's degree OR High School Diploma or equivalent AND Four (4) years of related experience.
2. Basic Life Support (BLS) certification may be required based on specific role requirements.

Preferred Qualifications:

1. Two (2) years in research related activities.
2. IATA Hazardous Good Shipping certification.
3. CITI Human Research Protection certification.

Duties and Responsibilities:

1. Assists in the recruitment of study participants.
2. Completes follow up with study participants in prescribed settings as required.
3. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
4. 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.
5. Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
6. Performs basic laboratory activities as needed.
7. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
8. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
9. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
10. Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
11. Maintains inventory of all study supplies.
12. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
13. Reviews all eligibility and ineligibility criteria in the patient's record.
14. Verifies information with the physician.
15. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
16. Conducts a QC check of completed CRFs prior to submission for data entry.
17. Coordinates resolution of all data queries.
18. Completes data entry as warranted.
19. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

Physical Requirements:

1. Typical clinical and administrative office setting.

Skills & Abilities:

1. High degree of organizational talents, data collection, and analysis skills.
2. Requires meticulous attention to detail.
3. Excellent computer skills including word processing.
4. Ability to prioritize quickly and appropriately.
5. Excellent communication and interpersonal skills.
6. Systematic record-keeping.