In House Clinical Research Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee and assist clinical sites from the approval stage through to the close-out process.

• Create study documents and tools, including templates for Informed Consent Forms (ICF).

• Aid sites in securing IRB approval and in preparing submission materials.

• Address regulatory board inquiries from sites regarding protocol and ICF clarifications.

• Ensure that all necessary regulatory documents for the site are in order before the shipment of investigational products.

• Perform routine file evaluations and assess site performance issues.

• Keep consistent communication with study sites to guarantee compliance.

• Conduct remote evaluations of data entered on electronic Case Report Forms (eCRFs).

• Support initiatives to recruit investigative sites for participation in clinical studies.

• Adhere to ICH GCP guidelines and FDA regulations.

• Participate in internal meetings, as well as those with clients/sponsors and scientific discussions as necessary.

• Manage and prioritize competing demands to fulfill commitments.

⛳️ Requirements

• Bachelor's degree (BS/BA) from an accredited program or equivalent experience.

• 1-2 years of experience in the field of clinical research.

• Demonstrated ability to be meticulous, comprehensive, and attentive to detail.

• Excellent organizational abilities along with the capability to juggle multiple tasks and perform effectively in a dynamic environment.

• Strong analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.

• A self-motivated individual who excels in a collaborative setting.

• Proficient command of the English language, both written and spoken.

• Exceptional communication and interpersonal skills with a focus on customer service.

• Proficient in the MS Office Suite, especially Word and Excel.

• Permanent authorization to work in the United States.

🏝️ Benefits

• Opportunities for professional development.

• Global travel opportunities.

• Flexible work programs.