Expedited Specialist

About the role

The Expedited Specialist II will conduct reviews of submitted human subject research applications in accordance with federal requirements, HRO policies and procedures and accreditation standards. Under the direction of the Assistant Director, the Expedited Specialist will work with personnel in all areas of the submission and review process to ensure appropriate screening and review of research documents, and provide support to research staff on research submissions, training requirements, and updated processing procedures.

Responsibilities

• Work independently to review research activity submitted to the MGB IRB to determine research is not human subjects research or a clinical investigation subject to IRB review;
• Determine if research meets exemption criteria;
• Approve non-exempt minimal risk research using the expedited review procedure;
• Afford minor changes in approved research;
• Conduct continuing review of approved minimal risk research;
• Review other events.

Requirements

• Education: Bachelor's degree required; Master’s degree in medically-related area preferred (Nurse Practitioner, Physician’s Assistant)
• Licenses and Certifications: Certified IRB professional (CIP) credential in good standing (or must pass certification exam within first 90 days of employment)
• Experience: At least 1-2 years of knowledge of federal, state, and local laws and regulations governing human subjects research required; Minimum of 3 years of relevant experience in IRB, clinical research, and/or regulatory affairs

Qualifications

• Excellent oral and written communication skills.
• Excellent organizational skills with the ability to prioritize work and adhere to timelines.
• Ability to assess institutional and federal criteria and apply it to a variety of situations, and make decisions based on specified criteria.
• Excellent interpersonal skills to effectively communicate with cross-functional teams, including staff at all levels of the organization and both scientific/medical and non-scientific/medical personnel.
• Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization.
• Ability to effectively conduct meetings, both formal and informal, and to lead and facilitate large working sessions with all levels of staff.
• Self-motivated, independent, and possesses the ability to learn quickly.

Skills

• Knowledge of federal, state, and local laws and regulations governing human subjects research.
• Ability to apply institutional and federal criteria to a variety of situations and make decisions based on specified criteria.
• Excellent communication and interpersonal skills.
• Organizational and prioritization skills.
• Problem-solving and collaboration abilities.
• Meeting facilitation and leadership skills.
• Learning agility.

Benefits

At Mass General Brigham, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.

Pay

$63,252.80 - $102,596.00/Annual

Schedule

Monday through Friday, 8:30 AM to 5 PM ET