Sr. In-house Clinical Research Associate

Alira Health•Boston, MA

14d

About The Position

THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE 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.

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.

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