Clinical Research Assistant

Job Description

About Company

Tufts Medicine is a prominent integrated health system committed to delivering exceptional, connected, and accessible care across Massachusetts by bringing together the best of academic and community healthcare. It encompasses Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home (an expansive home care network), and a large integrated physician network.

Tufts Medicine is an equal opportunity employer that values diversity and inclusion. The organization does not discriminate based on various protected characteristics, including race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, or marital status. They are dedicated to providing reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive employment benefits. Requests for accommodation can be made by emailing careers@tuftsmedicine.org.

Job Description (Detailed)

Job Profile Summary
This role is centered on research and development of new products, innovation, and the improvement of existing products and processes. It specifically focuses on duties within Research Programs and Projects, providing support for the development of new products and innovation. This includes Clinical roles engaged in research projects, performing basic, translational, and/or clinical research aimed at solving specific problems for an entity or community.

As a professional individual contributor role, this position may direct the work of lower-level professionals or manage processes and programs. The majority of time is dedicated to overseeing the design, implementation, or delivery of processes, programs, and policies utilizing specialized knowledge, typically acquired through advanced education. This is described as an entry-level role that applies broad theoretical job knowledge, usually obtained through advanced education. For an entry-level professional, work is closely supervised, problems faced are generally not difficult or complex, and the role involves explaining facts, policies, and practices related to the job area.

Job Overview
This position’s primary responsibility is to assist the Principal Investigator (PI) in the planning and implementation of assigned clinical research studies.

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 depending on the specific role.

Preferred Qualifications:
• Two (2) years in research-related activities.
• IATA Hazardous Good Shipping certification.
• CITI Human Research Protection certification.

Duties and Responsibilities:
• Assists in the recruitment of study participants.
• Completes follow-up with study participants in prescribed settings.
• Completes record abstraction of source documents, conducts required study measurements, and completes study Case Report Forms (CRFs) in accordance with best practice methods.
• 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 Principal Investigator (PI), the study sponsor, and the Institutional Review Board (IRB).
• Assists with Institutional Review Board (IRB) requirements, including meeting institutional educational requirements, submitting documents for review (amendments, adverse event reporting, annual reviews).
• Performs basic laboratory activities as needed.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
• Identifies and resolves problems with protocol compliance by notifying the investigator and, if necessary, the protocol sponsor.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
• Maintains inventory of all study supplies.
• Assesses potential patients and their 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 obtain signature for the informed consent form.
• Conducts a QC check of completed CRFs prior to submission for data entry.
• Coordinates resolution of all data queries.
• Completes data entry as warranted.
• Performs necessary tests as needed and appropriate to level of training, such as EKGs, Walk tests, etc.

Physical Requirements:
• The work primarily takes place in a typical clinical and administrative office setting.

Skills & Abilities:
• Requires a high degree of organizational talents, data collection, and analysis skills.
• Demands meticulous attention to detail.
• Possesses excellent computer skills, including proficiency in word processing.
• Ability to prioritize quickly and appropriately.
• Demonstrates excellent communication and interpersonal skills.
• Capable of systematic record-keeping.