Clinical Research Associate

The Position

The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.

Responsibilities

• Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final

reconciliation of study documents

• Routinely monitor TMF inspection readiness for assigned studies
• Assist Study Lead with investigational product and ancillary supplies management, accountability and

reconciliation activities

• Collect and/or review Essential Documents from investigational sites
• Review informed consent documents for accuracy and completeness
• Support investigator identification, feasibility, and activation activities
• Review monitoring visit reports for accuracy and completeness
• Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim

update meetings, data safety committee meetings, etc.)

• Perform QC (formatting, spelling and grammar, accuracy, consistency) of study-level documents (master

ICFs, study plans, manuals, CRFs/CRF completion instructions, etc.) in alignment with study protocols

• Contribute to the development of study-level documents ( study templates, manuals, guides,

newsletters, etc.)

• Provide updates on study/site status as needed to ensure timely study entry and updates are reflected

on ClinicalTrials.gov or equivalent

• Perform periodic data reviews as requested by Study Lead
• Prepare and present updates at team meetings as assigned by Study Lead
• Support central/referral laboratory set-up and on-time activation (eg specifications, user manual) as

delegated by the Study Lead

• Work closely with CRO to plan for execution of study start-up and ongoing study execution activities as

assigned by the Study Lead.

• Provide guidance and training to junior level team members as assigned by management
• Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or

efficiency

• Participate in process improvement projects including SOP/WI development
• Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory

requirements.

Requirements:

• 2 years in clinical research
• 1 year onsite monitoring/site management experience
• Experience managing/supervising vendors preferred
• Highly proficient knowledge and understanding of ICH-GCP

Preferred:

• 4-year college degree
• CRA certification