Clinical Research Coordinator II

Job Overview:This position will assist the Principal Investigators (PIs) and Cardiovascular Director of ClinicalResearch in planning and implementing clinical research studies as assigned.Job ProfileSummary​This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes.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 otherlower levelprofessionals or manage processes and programs.The majority oftime is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typicallyacquiredthrough advanced education.An entry level role that applies broad theoretical job knowledge typically obtained through advanced education.May require the followingproficiency:  work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.Job DescriptionMinimum Qualifications:1.Bachelor’sdegreeORHigh School Diploma or equivalentANDFour (4) years of related experience.2.Basic Life Support (BLS) certification may berequiredbased on specific role requirements.3. Two (2) years in research relatedactivities.Preferred Qualifications:1.Five (5) years inresearch relatedactivities.2.Previousexperience in clinical trials.3.IATA Hazardous Good Shipping certification.4. CITI Human Research Protection certification.Duties and Responsibilities:Theduties and responsibilities listedbeloware intended to describe the general nature of workandare not intended to be an all-inclusive list.Other dutiesand responsibilitiesmay be assigned.1.Responsibleforassistingin the recruitment of study participants.2.Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings asrequired.3.Completes follow up with study participants in prescribed settings asrequired.4.Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Formsin accordance withbest practice methods.5.Complies withall institutional policies and government regulationspertaining tohumansubjects’protections.6.Responsible forassistingwith Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements,submittingdocuments for review, adverse event reporting and annual reviews.7.Performs basic laboratory activities as needed.8.Maintainspatient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.9.Identifiesand resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.10.Arranges necessary tests and proceduresin accordance withprotocol requirements and reports results to the investigator.11.Performs necessary tests as needed and asappropriate tolevel of training such as EKGs, Walk tests,etc.12.Organizes andparticipatesin site visits with the study sponsor to review completeness and accuracy of study documentation.13.Maintainsinventory of all study supplies.14.Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.15.Reviews all eligibility and ineligibility criteria in the patient’s record.16.Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.17.Conductsa QC check of completed CRFs prior to submission for data entry.18.Coordinatesresolution of all data queries.19.Completesdata entry aswarranted.20.Maintainsregulatory binders, case report forms, source documents, and other study documents.21.Monitorsthe occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.Physical Requirements:1.Typical clinical and administrative office setting.Skills & Abilities:1.High degree of organizational talents, data collection and analysis skills.2.Requires meticulous attention to detail.3.Excellent computer skills including word processing.4.Ability to prioritize quickly and appropriately.5.Excellent communication and interpersonal skills.6.Systematic record-keeping.At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.Pay Range:$47,924.24 - $59,894.75