Senior Clinical Research Associate (Sr CRA)

Role Summary

The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This hybrid role typically requires on-site presence at least 3 days per week.

Responsibilities

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and program goals
• Supports the Study Lead to ensure clinical study activities including start-up, enrollment, maintenance, and closeout are executed appropriately
• Participates in protocol development and updates, coordinating with medical writing for amendments as needed
• Oversees aspects of study management and vendors to ensure high data quality
• Coordinates meeting agendas and minutes with the in-house team
• Participates in study design reviews from an operations perspective and site implementation tactics
• May assist in CRO/Vendor RFP reviews, bid defenses, and vendor selection proposals
• Supports development of study timelines and budgets; aims to meet timelines and deliverables within budget
• Develops study processes, workflow, and resource plans; adjusts as study progresses
• Escalates timelines, milestones, resourcing, and potential execution issues to the Study Lead
• Contributes to critical study documents such as informed consent templates, site management, and monitoring tools
• Manages distribution, review, and tracking of essential trial documents
• Ensures regulatory documents are submitted per timelines
• Participates in site budgets and contract reviews
• Participates in Investigator recruitment for protocols
• Conducts sponsor oversight visits and may conduct site qualification and initiation visits
• Develops and ensures compliance with the clinical monitoring plan; co-monitors as needed for training and QA
• Contributes to CRF design and content
• Maintains regulatory files for assigned sites; supports data quality and drug supply forecasting
• Supports study-wide activities with vendors, sample handling, drug re-supply, investigator payments, and central records quality
• Acts as in-house contact for protocol-related process questions
• Evaluates clinical study reports for accuracy, safety, and efficacy trends as needed
• Exercises judgment on protocol, drug questions, safety, regulatory, and legal issues
• Demonstrates knowledge of ICH guidelines, FDA regulations, and SOPs; coaches junior staff
• Contributes to SOP reviews and Clinical Operations initiatives
• Maintains Trial Master File throughout the study and supports TMF audits
• Maintains professionalism and teamwork with management, staff, and vendors
• Travel may be up to 30% occasionally

Qualifications

• Technical knowledge and experience managing most aspects of clinical studies
• Experience in the pharmaceutical industry
• Excellent knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, SOPs, and medical terminology
• Interpersonal, problem-solving, and organizational skills
• Self-motivated and able to motivate others
• Attention to detail and ability to prioritize tasks to meet deadlines
• Ability to read and understand scientific literature
• Excellent verbal and written communication
• Strong organization and time management
• Ability to develop and deliver concise presentations
• Ability to work effectively on project teams and independently
• Proficiency in Microsoft Office and related tools

Education

• BA/BS degree in a relevant field, nursing degree, or equivalent experience
• 4+ years of experience in clinical research for a Sponsor company, CRA/field monitor, or CRO setting