Job Description
Job Profile Summary
This role focuses on research and development of new products, innovation, and process improvement. It supports the development of new products and clinical research projects, including basic, translational, and clinical research aimed at solving specific problems for an entity or community. The position involves overseeing the design, implementation, or delivery of processes, programs, and policies using specialized knowledge typically acquired through advanced education. It is an entry-level role requiring broad theoretical knowledge, with supervision and problem complexity being relatively low.
Job Overview
This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.
Job Description
Minimum Qualifications:
Bachelor's degree OR High School Diploma or equivalent AND four (4) years of related experience.
Basic Life Support (BLS) certification may be required based on specific role requirements.
Preferred Qualifications:
Two (2) years in research-related activities.
IATA Hazardous Goods Shipping certification.
CITI Human Research Protection certification.
Duties and Responsibilities
Assist in recruiting study participants.
Follow up with study participants as required.
Complete record abstraction, conduct study measurements, and fill out Case Report Forms according to best practices.
Ensure compliance with policies and regulations related to human subjects, maintain study documents, and monitor adverse events.
Support IRB requirements, including document submissions and reviews.
Perform basic laboratory activities as needed.
Maintain patient confidentiality and adhere to HIPAA and FDA guidelines.
Identify and resolve protocol compliance issues.
Arrange tests and procedures as per protocol and report results.
Participate in sponsor site visits.
Maintain inventory of study supplies.
Assess patient eligibility based on protocol criteria.
Review patient records for eligibility.
Verify information with physicians.
Interview patients for eligibility and obtain informed consent.
Conduct QC of CRFs before data entry.
Coordinate data queries and perform data entry.
Perform tests like EKGs and walk tests as appropriate.
Physical Requirements
Typical clinical and administrative office setting.
Skills & Abilities:
Strong organizational, data collection, and analysis skills.
Meticulous attention to detail.
Excellent computer skills, including word processing.
Ability to prioritize tasks effectively.
Excellent communication and interpersonal skills.
Systematic record-keeping.
Tufts Medicine is committed to diversity and inclusion. We are an equal opportunity employer and provide reasonable accommodations for individuals with disabilities. Contact us at
[email protected] for accommodation requests.
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