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 CLINICAL RESEARCH ASSOCIATE
The Clinical Research Associate (CRA) is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs and/or Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
ESSENTIAL JOB FUNCTIONS*
- Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs
- Ensures integrity of CRF data through meticulous and thorough source document review
- Conducts investigational product accountability
- Reviews regulatory binder for required documents
- Works closely with in-house CRAs and data management to resolve queries on discrepant data
- Proactively identifies site issues and develops problem-solving strategies for sites
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests
- Conducts audit preparation at study sites as needed
- Works with other CRAs to maintain consistency and promote a good team atmosphere
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs
- Participates in industry and client meetings
- 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
- 2 years’ clinical research experience
- Ability to travel
- 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.