Job Description

Senior Clinical Research Associate
Location: Remote, Midwest or Western United States
Employment Type: Contract
Travel: Regular travel to assigned clinical study sites

Position Overview
IntePros is seeking an experienced Senior Clinical Research Associate to support a full-service clinical research organization working with pharmaceutical, biotechnology and medical-device companies.

The Senior Clinical Research Associate will independently manage assigned clinical study sites and conduct monitoring activities throughout the clinical trial lifecycle. This person will work closely with Clinical Project Managers, study teams, investigative sites and sponsor representatives to support study execution, regulatory compliance, data quality and patient safety.

The ideal candidate has at least five years of direct clinical-study monitoring experience and can effectively oversee sites with limited supervision. Experience supporting oncology or rare disease clinical trials is strongly preferred.

Responsibilities
• Track study-monitoring activities and conduct monitoring and co-monitoring visits
• Perform site qualification, study initiation, routine monitoring and study closeout visits
• Prepare confirmation letters, follow-up communications and accurate monitoring reports
• Independently manage assigned clinical study sites
• Identify and resolve site-performance issues involving protocol compliance, ICH-GCP requirements, subject recruitment and data collection
• Conduct remote monitoring activities and identify potential study or site-level trends
• Oversee the timely resolution of data-entry queries, missing data and monitoring findings
• Review enrollment and patient-status activity for assigned sites at least weekly
• Provide training, guidance and ongoing support to investigative-site personnel
• Partner with Clinical Project Managers and functional-area leads to develop study documents, including protocols, informed-consent forms, case report forms, study manuals and clinical monitoring plans
• Work with clinical operations personnel to develop and maintain accurate, complete and current clinical study files
• Upload required site and study documentation to the electronic Trial Master File within established timelines
• Support recurring eTMF reconciliations and inspection-readiness activities
• Assist with investigator-grant reconciliation and serious adverse event reconciliation when needed
• Provide clear and accurate weekly updates to the Clinical Trial Manager
• Develop productive relationships with site personnel, sponsor representatives and internal study-team members
• Provide clinical-monitoring mentorship and training to junior team members when requested
• Assist with quality-control reviews of clinical study reports and safety narratives
• Complete required company and project-specific training within established timelines
• Remain current on regulatory requirements and guidelines affecting assigned studies
• Submit timesheets and travel expenses accurately and on time

Required Qualifications
• Bachelor's degree in a scientific discipline or related field
• Candidates with a bachelor's degree in another discipline or an RN credential may be considered with appropriate experience
• At least five years of pharmaceutical or biotechnology industry experience
• At least five years of direct CRA or clinical-study monitoring experience
• Demonstrated ability to independently conduct site qualification, initiation, routine monitoring and closeout visits
• Strong understanding of the clinical trial process from study initiation through reporting
• Working knowledge of FDA regulations, ICH-GCP guidelines and applicable clinical research requirements
• Experience identifying, documenting and resolving site-compliance and performance issues
• Strong written and verbal communication skills
• Excellent organization, documentation and attention to detail
• Ability to work effectively with limited supervision
• Proficiency with Microsoft Office and standard clinical research systems
• Ability and willingness to travel regularly to assigned study sites
• Residence in the Midwest or Western United States, preferably near a major airport

Preferred Qualifications
• Oncology clinical-trial experience
• Rare disease clinical-trial experience
• Experience with eTMF, EDC and CTMS platforms
• Experience performing remote monitoring activities
• Previous experience mentoring or training junior CRAs
• Experience performing GCP audits
• Experience supporting clinical study reports or preparing safety narratives

Working Conditions
This is a remote position that requires regular travel to investigative sites. Travel frequency will depend on study activity, enrollment and assigned-site requirements. Candidates must be able to manage multiple sites, deadlines and competing priorities while maintaining accurate and timely documentation.

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