Position Description: The Clinical Research Project Coordinator II provides oversight and support in the research and non-clinical administrative aspects of projects involving human subjects. The incumbent implements and oversees the daily operations of the study which include monitoring participant recruitment, implementing protocols, managing research data and samples, and supervising staff. Assists with administrative functions including IRB compliance, maintaining supplies, writing proposals, ensuring compliance with grant criteria, assisting in marketing initiatives, and providing reports. The incumbent maintains data required by sponsors, aids in preparing project-related reports, and serves as a resource to all entities/individuals involved in the specific research study. Additionally, the incumbent assists in preparing and reviewing submissions to sponsors, including budgeting, and/or maintaining and managing project budgets.

Education: Bachelor's Degree Required

Experience: Minimum 3 to 5 Years

Certifications: CCRP, CCRA, or ACRP-CP preferred

Responsibilities may include any or all of the following:

• Manages research project(s) involving human subjects

• Trains and supervises project specific staff (Clinical Research Assistants I-III, volunteers, students, consultants, etc); records HR issues as needed

• Assists in the planning, implementation, and management of project data

• Promotes the project(s) through marketing, website, other sources, etc.

• Coordinates project meetings including creating agendas and drafting minutes

• Collaborates on presentations, publications, and dissemination of project results, as requested

• Supervises biospecimen collection, packaging, shipping, and infection control procedures

• Aids in preparation of IRB protocols, amendments, annual reviews, risk assessments, adverse event reports, and informed consent documents; communicates with IRB throughout submission and review process

• Supports Principal Investigator in preparing regulatory reports, including convening DSMB meetings and writing DSMB reports, and assisting with sponsor progress reports.

• Helps prepare and review grant submissions, including budgets, according to sponsor guidelines and/or

• Manages financial functions related to grant and budget compliance

• Interfaces with grants management office and sponsors

• Perform clinical operations of research transthoracic echocardiograms including preliminary interpretation of studies, including an assessment of ventricular performance.

• Utilize 2D, M-Mode and Doppler techniques to evaluate and record pertinent anatomical, pathological and functional data.

• Explain and answer any questions a participant may have to ensure comfort level for the testing procedure.

• Demonstrate proficiency in performing routine echocardiograms utilizing independent judgment and manipulation of equipment to obtain all necessary measurements.

• Recognize cardiac abnormalities and notify the research Cardiologist of any IRB approved Red Flags criteria met.

• Download and prepare echocardiograms for research cardiologist review.

• Demonstrate proficiency in Ankle Brachial Index (ABI) Measurements, record ABI measurements.

• Perform ECGs, recognize ECG abnormalities and notify the research cardiologist of abnormal findings.

Care New England Health System (CNE) and its member institutions, Butler Hospital, Women & Infants Hospital, Kent Hospital, VNA of Care New England, Integra, The Providence Center, and Care New England Medical Group, and our Wellness Center, are trusted organizations fueling the latest advances in medical research, attracting top specialty-trained doctors, and honing renowned services and innovative programs to engage in the important discussions people need to have about their health.

EEOC Statement: Care New England is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Ethics Statement: Employee conducts himself/herself consistent with the ethical standards of the organization including, but not limited to hospital policy, mission, vision, and values.

Americans with Disability Act Statement: External and internal applicants, as well as position incumbents who become disabled must be able to perform the essential job-specific functions either unaided or with the assistance of a reasonable accommodation, to be determined by the organization on a case-by-case basis.