Clinical Research Coordinator I

Baystate Health•Springfield, MA

About The Position

The Clinical Research Coordinator I will be the primary administrator of site, will monitor the research plan and protocol, ensure subject enrollment goals are being met and that analyses are occurring on time. He/she will also managing the components of the project, including: the IRB responsibilities, assisting with the functioning of the DSMB, Patient Advisory Board, and Stakeholders Advisory Board, and working closely with the Principal Investigator.

Requirements

High School / GED
Solid knowledge of medical terminology.
Solid knowledge of State and Federal Regulations and Guidance's as they relate to research.
Highly detail-oriented individual with excellent interpersonal and time management skills.
Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program.
Must obtain CCRP certification when eligible, it may take up to 2 years to be eligible
GED or HiSET

Nice To Haves

Bachelor's degree
Master's eegree
None Listed
Solid knowledge of medical terminology
Certified Clinical Research Professional - Association of Clinical Research ProfessionalsAssociation of Clinical Research ProfessionalsAssociation of Clinical Research Professionals, Must obtain CCRP certification when eligible, it may take up to 2 years to be eligible - per research compliance

Responsibilities

Conducts study tasks that are moderately complex in accordance with established protocols or guidelines
Works with patients & families. May conduct screening of patients for inclusion in non-interventional studies based on predetermined criteria.
Assists with study procedures and the collection of complex data.
Assists in screening of patients for inclusion in interventional studies based on predetermined criteria.
Assists with/conducts informed consent process for non-interventional studies with the PI/SubI available for questions.
Assists with the informed consent process for interventional studies.
Assists with patient education regarding protocol and requirements.
Contributes to preparation, submission, and maintenance of regulatory documents.
Contributes to and maintains study and patient files in a highly organized manner.
May contribute to development of study specific source and site documentation. Secures study and patient files to ensure confidentiality.
Performs actual tasks. Records & Organizes Data. Contributes to and maintains source documents and case report forms.
Compiles information for interpretation.
Works in collaboration with IRB, SPA, and other BMC areas for study success.
Responsibilities may include meetings and collaboration with sponsor/CRO for study success.
Responsibilities may include travel as needed for Investigator Meetings, etc.
May assist in coordinating and supervising assigned study activities.
May assist with training of lesser qualified study personnel
Provides feedback on the performance of Research Assistant staff for performance evaluation purposes.