Sr. In-house Clinical Research Associate at Alira Health in Framingham

Job description

• The Sr. In-house CRA is an important member of the Alira Health Clinical team. Sr. In-house CRAs manage and support clinical sites from site approval through close-out. Sr. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for 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 sitespecific 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.

Skills

Required

• Careful, thorough, detail-oriented
• Organizational skills
• Multi-tasking
• Analytical
• Negotiation
• Meeting management
• Cross-functional team skills
• Leadership
• Self-starter
• Problem-solving
• Communication
• Interpersonal

Benefits

• The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.
• 75,000 - 90,000