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 close-out.

• Create study documents and resources, including templates for informed consent forms (ICF) and contents for site binders.

• Provide support to sites regarding IRB approvals, submission materials, and site-specific ICFs.

• Address requests from regulatory boards for clarifications on protocols and ICFs.

• Ensure all necessary regulatory documents and approvals are secured prior to the shipment of investigational products.

• Collect, organize, and regularly review regulatory documents at sites and within the Trial Master File (TMF).

• Evaluate site performance and adherence to protocols, identify issues, and deliver ongoing training to sites.

• Maintain communication with study sites about protocol and Good Clinical Practice (GCP) compliance, as well as subject enrollment rates.

• Perform remote reviews of electronic Case Report Form (eCRF) data.

• Work alongside field Clinical Research Associates (CRAs) and data management to address discrepancies in data queries.

• Assist in the recruitment of investigative sites.

• Adhere to ICH GCP guidelines, FDA regulations, and company Standard Operating Procedures (SOPs).

• Engage in internal meetings, as well as those with clients/sponsors, scientific discussions, and other required gatherings.

• Manage competing priorities effectively and fulfill commitments.

• Execute additional assigned responsibilities.

⛳️ Requirements

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

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

• Demonstrated ability to be meticulous, thorough, and detail-oriented.

• Excellent organizational skills with the capability to handle multiple tasks in a dynamic environment.

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

• Capacity to tackle unstructured or ambiguous challenges effectively.

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

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

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

• Permanent authorization to work in the United States.

🏝️ Benefits

• Opportunity for remote work with limited travel, facilitating collaboration across geographical boundaries and time zones.