Clinical Research Coordinator II - WoMB

Tufts Medicine; Lowell, Northern (MA, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Tufts Medicine is seeking a Clinical Research professional to support the development of new products and the innovation of clinical trial processes within our research programs.

You will assist the Principal Investigator in planning and implementing clinical studies, coordinating IRB submissions, ensuring HIPAA compliance, and reporting results in line with FDA Good Clinical Practice guidelines, under close supervision.

Qualifications

• Bachelor's degree OR High School Diploma or equivalent AND four years of related experience.
• Basic Life Support (BLS) certification may be required based on role requirements.
• Preferred qualifications include experience in clinical trials.

Responsibilities

• Assist with IRB requirements for each study including education, submissions, adverse event reporting and annual reviews.
• Maintain patient confidentiality per HIPAA and ensure study information is secure.
• Adhere to FDA Good Clinical Practice Guidelines and coordinate tests per protocol.

Skills

Organizational skills

Data collection & analysis

Excellent communication

Education

Bachelor's degree

High School Diploma or equivalent

Job description

In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. 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:**2. Previous experience in clinical trials.**Duties and Responsibilities:** The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.6. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.14. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.**Physical Requirements:****Skills & Abilities:**1. High degree of organizational talents, data collection and analysis skills.3. Excellent computer skills including word processing.4. Ability to prioritize quickly and appropriately.5. Excellent communication and interpersonal skills.Tufts Medicine is a leading integrated health system bringing together the best of academic and community health care to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care network and a large clinically integrated physician network, Tufts Medicine has more than 15,000 dedicated employees and caregivers. The health system came together in 2014 to leverage the experience of its member organizations and integrate their missions to together transform the ways that consumers engage with and experience their care.