In-house Clinical Research Associate II

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

📋 Description

• Assist in gathering feasibility questionnaires and collecting CDAs from prospective sites.

• Oversee the shipment and receipt of study materials at participating sites.

• Revise and conduct quality checks on site-related documents for inclusion in the Trial Master File (TMF).

• Aid field CRAs in maintaining the Investigator Site File, reconciling TMF, and ensuring TMF quality control.

• Execute pre-study, study initiation, interim, remote monitoring, and close-out visits under supervision.

• Assist with the management of investigational product inventory.

• Maintain consistent communication with study sites.

• Conduct remote reviews of electronic data capture (EDC) case report forms.

• Support sites in resolving EDC and vendor inquiries.

• Generate reports, manage study trackers, and provide updates to Clinical Trial Managers.

• Prepare field CRAs for site visits by summarizing action items, protocol deviations, queries, supplies, and training requirements.

• Assist in handling changes in site staff, including documentation, qualifications, training, and task distribution.

• Manage vendor access for site personnel.

• Support prescreening, screening, and participant recruitment efforts.

• Aid in tracking Subject Eligibility Review and assist the Medical Monitor.

• Act as the operational point of contact for clinical research trials when necessary.

• Mentor and train In-house CRA I and II team members.

• Attend and provide updates during study meetings.

• Execute other assigned duties.

⛳️ Requirements

• Strong oral and written communication abilities.

• Excellent planning and organizational skills, coupled with effective time management.

• Good interpersonal skills.

• Capacity to work in a systematic and organized manner.

• Solid understanding of clinical research principles and processes.

• Familiarity with FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory standards; training will be provided by WCT.

• Strong knowledge of standard operating procedures; training will be given by Worldwide Clinical Trials.

• Basic proficiency in Microsoft Office.

• Familiarity with IVRS and eCRF systems; training will be provided by Worldwide Clinical Trials.

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related science.

• At least two years of clinical research experience (e.g., study coordinator, research nurse, etc.).

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.