In-House CRA: Centralized Clinical Trials Support

Advanced Recruiting Partners; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Advanced Recruiting Partners seeks an experienced In-House Clinical Research Associate (CRA) to support planning, conduct, and oversight of clinical trials. You will work with Clinical Operations, CRAs, Trial Managers, investigators, and cross-functional teams to ensure studies comply with the protocol, ICH-GCP, and sponsor SOPs.

The role focuses on centralized trial support, trial documentation, site support, data review, study tracking, and timely communications with sites and field CRAs.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 2+ years of clinical research experience, preferably in CRO/pharma.
• Experience supporting trials from start-up to close-out preferred.
• Working knowledge of ICH‑GCP, FDA regulations, and trial processes.

Responsibilities

• Provide centralized support to clinical study teams and field CRAs throughout the study lifecycle.
• Support start-up activities, site activation, and regulatory documentation.
• Assist with site identification, feasibility, selection, and activation.
• Review TMF/ISF documents and conduct remote data review to identify discrepancies and trends.
• Support site monitoring by reviewing reports, follow-ups, action items, and issues.
• Maintain study trackers for activation, enrollment, monitoring, deviations, queries, and metrics.
• Communicate with clinical sites and field CRAs to resolve issues and meet deliverables.
• Prepare study materials, meeting minutes, newsletters, and communications.
• Support study status reports and operational metrics for managers.
• Assist investigator meetings, site initiation, and study close-out activities.
• Ensure activities comply with protocol, ICH‑GCP, regulations, and sponsor/CRO SOPs.
• Identify risks and elevate significant issues to the study team.
• Participate in team meetings and continuous improvement initiatives.
• Maintain accurate documentation of all study-related activities.

Skills

CRA experience

ICH-GCP

CTMS

TMF/eTMF

EDC

Cross-functional teamwork

Education

Life sciences degree

Healthcare degree

Tools

CTMS

EDC

eTMF

IWRS/IRT

MS Office

Job description

Advanced Recruiting Partners seeks an experienced In-House Clinical Research Associate (CRA) to support planning, conduct, and oversight of clinical trials. You will work with Clinical Operations, CRAs, Trial Managers, investigators, and cross-functional teams to ensure studies comply with the protocol, ICH-GCP, and sponsor SOPs.

The role focuses on centralized trial support, trial documentation, site support, data review, study tracking, and timely communications with sites and field CRAs.