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Job Description SummaryJob DescriptionTHE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLEThe 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.
ESSENTIAL JOB FUNCTIONS- 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
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES- 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.
WORKING CONDITIONS/PHYSICAL DEMANDSNormal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
LanguagesEnglish
EducationBachelor of Science (BS)
Contract TypeRegular
Salary RangeThe 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
