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 study start-up, enrollment, maintenance, and closeout are executed appropriately
• Participates in protocol development and works with medical writing to create protocol 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 review of study designs from an operations perspective and site implementation tactics
• May support vendor RFP reviews, bid defenses, and proposals for vendor selection
• Supports development of study timelines and budgets; monitors progress to meet timelines within budget
• Develops study processes and resource plans; adapts as study progresses
• Escalates timeline and resourcing concerns to the Study Lead
• Contributes to critical study documents such as informed consent templates, site management tools, and monitoring tools
• Participates in distribution, review, and tracking of essential trial documents and ensures regulatory submissions per timelines
• Participates in site budget and contract reviews
• Involved 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; reviews edits
• Maintains regulatory files for assigned sites and ensures data quality
• Liaises with CMC to forecast drug supply and track expiration; reviews site accountability logs as needed
• Supports study-wide activities such as vendor management, sample handling, drug re-supply, payments, and data quality
• Acts as in-house contact for protocol-related questions
• Evaluates clinical study reports for accuracy, safety, and efficacy trends as needed for medical monitor review or IDMC meetings
• Uses judgment to resolve protocol, safety, regulatory, and legal questions; seeks expert input as appropriate
• Demonstrates knowledge of ICH guidelines, FDA regulations, and SOPs; mentors junior staff
• Contributes to TMF maintenance and periodic audits
• Maintains professionalism and collaboration with management, supervisors, team members, 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
• Able to work effectively on project teams and independently
• Proficiency in Microsoft Office and related computer tools
• BA/BS in a relevant field, nursing degree, or equivalent experience
• 4+ years of experience in clinical research for a Sponsor, CRA/field monitor, or CRO

Education

• BA/BS degree in a relevant field, nursing degree, or equivalent experience