ABOUT ALIRA HEALTH CLINICAL
The Alira Health Clinical team delivers clinical excellence from the big strategic picture to the hands-on management of every aspect of clinical trials. We have over 20 years of clinical trial expertise in a variety of indications, with a focus on accurate, effective, and meaningful clinical trial outcomes. Our multi-disciplinary team understands the whole clinical trial process. Our proactive approach and creative problem-solving abilities allow us to lead clinical trials efficiently, safely, and successfully.
THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE
The In-house Clinical Research Associate (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 Project Managers without the need for frequent travel.
ESSENTIAL JOB FUNCTIONS*
- Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, tip cards, 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 audits
- 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
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
- BS/BA from an undergraduate program or equivalent experience
- 1-2 years’ clinical research experience
- 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
- 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
- Working knowledge of MS Office Suite, particularly Word and Excel
- Self-starter who thrives in a collaborative, yet less structured team environment
- Permanent authorization to work in the U.S.
WORKING CONDITIONS/PHYSICAL DEMANDS
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs. The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act, must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.