Site relationship management role ensuring sustainable trial start - up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
About the role
- Sr. In-house CRA managing and supporting clinical sites from approval to close-out for Alira Health. Collaborating with field CRAs to ensure trial data integrity without frequent travel.
Responsibilities
- Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), Investigator Site File (ISF) contents, etc.
- Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
- Responds to sites’ regulatory board requests for protocol and ICF clarification as needed
- Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment
- Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews
- Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites
- Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests
- Conducts remote review of data entered on electronic Case Report Forms (eCRFs) as needed
- Works closely with field CRAs and data management to resolve queries on discrepant data
- Assists with efforts to recruit investigative sites to participate in clinical studies
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned
Requirements
- BS/BA from an undergraduate program or equivalent experience
- At least 7 years of experience in clinical research
- Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Self-starter who thrives in a collaborative, yet less structured team environment
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of English, both written and verbal
- Excellent communication and interpersonal skills with customer service orientation
- Proficient with MS Office Suite, particularly Word and Excel
- Permanent authorization to work in the U.S.
Benefits
- Professional development
- Global travel
- Flexible work programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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