Research Support - Baystate Health
Category(s): Research, Research Support
Full Time / Part Time: Full-Time
Advises Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities.
Works in collaboration with IRB, SPA, and other BMC areas for study success. Records & Organizes Data. Contributes to and maintains source documents and case report forms. Compiles information for interpretation. Responsibilities may include meetings and collaboration with sponsor/CRO for study success.
1) Prepares submissions to the IRB, SPA, sponsors, contract research organizations, regulatory agencies, etc. in collaboration with investigators and other research personnel in a skilled and timely manner.
2) Maintain electronic databases to track regulatory documents, submissions, etc.
3) May Ship blood samples/specimens.
4) May have other responsibilities including maintenance of refrig./freezer logs, inventory/ordering of study supplies, scheduling of study appts, budget tracking, etc.
5) Assists with sponsor visits. May perform actual study tasks as appropriate in accordance with BMC policies and federal and state regulations.
6) Creates and maintains well organized and complete regulatory binders.
7) Contributes to and maintains study and patient files in a highly organized manner.
8) Maintains updated curriculum vitals and licenses for all investigators and research staff.
9) Contributes to ICF development.
10) Secures study and patient files to ensure confidentiality.
Required Work Experience:
1) Knowledge and skills necessary for this level are typically attained through 2-4 years of clinical research experience
2) Solid understanding of data collection and research principles
3) Highly detail-oriented individual with excellent interpersonal and time management skills
4) Strong computer skills including database and web-based applications
Preferred Work Experience:
1) None Listed
Skills and Competencies:
1) Strong knowledge of IRB requirements and Federal and State regulations as they relate to research
2) Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program
3) Records & Organizes Data
4) Contributes to and maintains source documents and case report forms
5) Compiles information for interpretation
6) Advises Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities
7) Works in collaboration with IRB, SPA, and other BMC areas for study success
8) Responsibilities may include meetings and collaboration with sponsor/CRO for study success
You Belong At Baystate
At Baystate Health we know that treating one another with dignity and equity is what elevates respect for our patients and staff. It makes us not just an organization, but also a community where you belong. It is how we advance the care and enhance the lives of all people.
DIVERSE TEAMS. DIVERSE PATIENTS. DIVERSE LOCATIONS.
Bachelor of Science (Required)
Clinical Research Coordinator – Association of Clinical Research Professionals
Equal Employment Opportunity Employer
Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.