Clinical Assistant

Posted:
10/30/2024, 5:38:11 AM

Location(s):
Massachusetts, United States ⋅ Framingham, Massachusetts, United States

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Medical, Clinical & Veterinary

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Clinical Assistant assists the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies providing administration and project tracking support. 

Under supervision, the Clinical Assistant provides support to the Clinical team during the start-up, execution, and close-out of clinical studies, including a variety of supportive clinical trial management tasks. 

KEY RESPONSABILITIES

  • Prepares meeting materials, attends meetings, and prepares meeting minutes.

  • Assists with preparing and assembling study documents and materials, including ISF.

  • Ships study materials/ISF to participating clinical sites.

  • Sorts study-specific email repositories.

  • Assists with maintenance of Trial Master Files (TMFs).

  • Supports with ethic/regulatory documents preparation and sites’contract negotiation.

  • Maintains relationship with ECs and CA at national level.

  • Assists with site communication.

  • Assists in sites/vendors invoicing management and tracking.

  • Collaborates in the preparation of weekly/monthly and ad hoc project reports, also updating CTMS and maintains study-specific trackers as needed.

  • Supports in CRAs activities follow-up.

  • Supports with document translation, if required and based on level of English.

  • Participates in internal, client/sponsor, scientific, and other meetings as required.

  • Performs additional duties as assigned. 

  • Provides general administrative support to the Department.

DESIRED QUALIFICATION & EXPERIENCE

  • Either relevant work experience or Scientific High School Diploma, Bachelor’s Degree preferred 

  • Research or health care related academic/work experience preferred 

  • Basic knowledge of ICH GCP and appropriate regulations 

  • Basic knowledge of Clinical Research and Regulatory and Ethical requirements 

TECHNICAL COMPETENCES & SOFT SKILLS 

  • English, medium/good 

  • MS Office Suite, Good 

  • Professional  

  • Trustworthy 

  • Ability to effectively prioritize 

  • Quality focused 

  • Personable Attitude 

  • Willingness to learn  

Languages

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences

Contract Type

Regular