Clinical Research Proj Coord I

Job Summary

The Clinical Research Project Coordinator I provides supervision and non-clinical administrative support for research projects involving human subjects. This position coordinates the daily activities of the project and serves as a point of contact for the Principal Investigator, sponsor, and junior study staff. Responsible for initiating and maintaining participant recruitment, tracking study participants, and facilitating data collection. Ensures completion of study procedures and adherence to research protocol(s). Maintains study records and may assist with IRB and regulatory submissions.

Duties & Responsibilities

Responsibilities may include any or all of the following:

• Responsible for the management of research project(s) involving human subjectts
• Trains and supervises project specific staff (Clinical Research Assistants I-III, volunteers, students, consultants, etc); records HR issues as needed
• Develops and implements participant recruitment plan
• 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
• Supports Principal Investigator in preparing regulatory reports, including convening and preparing for DSMB meetings, and assisting with sponsor progress reports as necessary

Requirements

• Bachelor’s Degree Required
• Minimum 1-3 years experience
• CCRP, CCRA, or ACRP-CP preferred
• Excellent communication skills and analytic abilities
• Basic computer skills, e.g. familiarity with Microsoft software, completing spreadsheet/data entry.
• Ability to work with diverse populations and support an inclusive, culturally responsive environment.

About Us

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, is a trusted, integrated health care organization that fuels the latest advances in medical research, attracts the nation’s top specialty-trained doctors, hones renowned services and innovative programs, and engages in the important discussions people need to have about their health and end-of-life wishes. Care New England is helping to transform the future of health care, providing a leading voice in the ongoing effort to ensure the health of the individuals and communities we serve.

EEO Statements

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.

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.

Responsibilities may include any or all of the following:

• Responsible for the management of research project(s) involving human subjectts
• Trains and supervises project specific staff (Clinical Research Assistants I-III, volunteers, students, consultants, etc); records HR issues as needed
• Develops and implements participant recruitment plan
• 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
• Supports Principal Investigator in preparing regulatory reports, including convening and preparing for DSMB meetings, and assisting with sponsor progress reports as necessary
• Bachelor’s Degree Required
• Minimum 1-3 years experience
• CCRP, CCRA, or ACRP-CP preferred
• Excellent communication skills and analytic abilities
• Basic computer skills, e.g. familiarity with Microsoft software, completing spreadsheet/data entry.
• Ability to work with diverse populations and support an inclusive, culturally responsive environment.