• Employment Type: Full Time
• Shift: Days
• Hours: 8-4:30
• Location: Boston, MA

The Clinical Research Coordinator II coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Tufts Medical Center policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and Ophthalmology study team members and external institutions, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

• Responsible for Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
• Create and maintain tracking for all subsequent SRC/IRB submissions, protocol and consent amendments, safety reporting, deviation, violation or other event reporting. Ensure various regulatory reporting requirements are met.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice (GCP) guidelines.
• Reviews existing protocols, taking time to prepare approval submissions, filing regulatory documents, implementing improvements as needed, and following regulations regarding researcher, assessment, and data gathering accurately.
• Collaborates with research coordinators, principal investigators, and other departments with the submission of protocol amendments and other regulatory submissions.
• Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies/offices to ensure all required information is relayed and responsible for the systematic documentation/tracking when applicable.
• Maintain working knowledge of current regulations, regulatory guidance and or local policies
• Assists Clinical Research Director with regulatory based training and implementation of new or revised regulation, guidance and/or local policy.
• Assess and prioritize needs of regulatory projects in the department; assigning tasks to research assistants as appropriate and supervising projects to completion
• Maintains collaborative team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment.
• Performs other similar and related duties as required or directed.

JOB KNOWLEDGE AND SKILLS:

• High degree of organizational talents, data collection and analysis skills.
• Requires meticulous attention to detail.
• Excellent computer skills including word processing
• Ability to prioritize quickly and appropriately
• Excellent communication and interpersonal skills
• Care in organization and systematic record-keeping Previous experience in clinical trials desirable

EDUCATION:

• BS or equivalent

EXPERIENCE:

• 2-5 years experience in research related activities

An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements.

LICENSES, ETC.:

• BLS certification may be required based on specific role requirements
• IATA Hazardous Good Shipping Certification
• CITI Human Research Protection Certification

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Typical clinical and administrative office setting.
• Must be able to perform all essential functions of this position with reasonable accommodation if disabled.
• May access PHI/HIPAA identifiers as part of daily tasks.

AMERICANS WITH DISABILITIES STATEMENT:

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

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

COVID-19 POLICY:

Please note that effective October 1, 2021, as a condition of employment at Tufts Medical Center, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.