In-House Clinical Research Associate-2

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description
ROLE
The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. 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.

KEY RESPONSABILITIES
Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder 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)

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

Compensation: USD $55,000 - 70,000

DESIRED QUALIFICATION & EXPERIENCE
BS/BA from an undergraduate program or equivalent experience

1-2 years of experience in clinical research

TECHNICAL COMPETENCES & SOFT SKILLS
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.

Languages
English
Education
Bachelor of Arts (BA), Bachelor of Science (BS)
Contract Type
Regular