Clinical Research Coordinator I

Baystate Health, is Western Massachusetts’s premier healthcare provider and home to Baystate Medical Practices, the largest multispecialty group in the region. Baystate Medical Center, is also the region’s only level 1 trauma center and pediatric trauma center.

The Clinical Research Coordinator I will be the primary administrator of a site. They 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

manage 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.

Job Responsibilities:

1) Conducts study tasks that are moderately complex in accordance with established protocols or guidelines

2) Works with patients & families. May conduct screening of patients for inclusion in non-interventional studies based on predetermined criteria.

3) Assists with study procedures and the collection of complex data.

4) Assists in screening of patients for inclusion in interventional studies based on predetermined criteria.

5) Assists with/conducts informed consent process for non-interventional studies with the PI/SubI available for questions.

6) Assists with the informed consent process for interventional studies.

7) Assists with patient education regarding protocol and requirements.

8) Contributes to preparation, submission, and maintenance of regulatory documents.

9) Contributes to and maintains study and patient files in a highly organized manner.

10) May contribute to development of study specific source and site documentation. Secures study and patient files to ensure confidentiality.

11) Performs actual tasks. Records & Organizes Data. Contributes to and maintains source documents and case report forms.

12) Compiles information for interpretation.

13) Works in collaboration with IRB, SPA, and other BMC areas for study success.

14) Responsibilities may include meetings and collaboration with sponsor/CRO for study success.

15) Responsibilities may include travel as needed for Investigator Meetings.

16) May assist in coordinating and supervising assigned study activities.

17) Provides feedback on the performance of Research Assistant staff for performance evaluation purposes.

Required Education:

High School / GED

Preferred Education:

Bachelor's degree

Master's degree

Required Work Experience:

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.

Preferred Work Experience:

Medical or Radiation Oncology and/or Research Terminology.

Solid knowledge of State and Federal Research Regulations and Guidance's

Skills and Competencies:

Solid knowledge of medical terminology. Microsoft office products. Experience with an electronic medical record Computer Application. He/She will be adaptable with changing platforms. Clinical & software applications. A self starter who is accountable for performance outcomes and has the ability to prioritize with competing priorities; Coordinator will be responsible for up to 20 different clinical trials and has the ability to work well both autonomously and within a team.

Certifications:

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.

Within 90 days of hire. Packaging and Shipping of Dangerous Substances (Human Blood and Tissue) Certification thru the Centers for Disease Control and Prevention.