CHEManager International
Sr. In-house Clinical Research Associate
CHEManager International, Boston, Massachusetts, us, 02298
Sr. In-house Clinical Research Associate
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. They 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
Develop study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), Investigator Site File (ISF) contents, etc.
Support sites in obtaining IRB approval, developing submission materials, and creating site‑specific ICFs.
Respond to sites’ regulatory board requests for protocol and ICF clarification as needed.
Ensure all required site regulatory documents and approvals are in place prior to investigational product shipment.
Ensure all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conduct routine file reviews.
Analyze site performance problems (protocol adherence) and identify solutions; provide ongoing training for study sites.
Maintain regular communication with study sites to ensure protocol/GCP compliance, assess subject accrual rates, and respond to sponsor requests.
Conduct remote review of data entered on electronic Case Report Forms (eCRFs) as needed.
Work closely with field CRAs and data management to resolve queries on discrepant data.
Assist with efforts to recruit investigative sites to participate in clinical studies.
Comply with ICH GCP guidelines, FDA regulations, and company SOPs.
Participate in internal, client/sponsor, scientific, and other meetings as required.
Manage and resolve conflicting priorities to deliver on commitments.
Perform 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 Demands Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
Languages English
Education Bachelor of Science (BS)
Contract Type Regular
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Essential Job Functions
Develop study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), Investigator Site File (ISF) contents, etc.
Support sites in obtaining IRB approval, developing submission materials, and creating site‑specific ICFs.
Respond to sites’ regulatory board requests for protocol and ICF clarification as needed.
Ensure all required site regulatory documents and approvals are in place prior to investigational product shipment.
Ensure all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conduct routine file reviews.
Analyze site performance problems (protocol adherence) and identify solutions; provide ongoing training for study sites.
Maintain regular communication with study sites to ensure protocol/GCP compliance, assess subject accrual rates, and respond to sponsor requests.
Conduct remote review of data entered on electronic Case Report Forms (eCRFs) as needed.
Work closely with field CRAs and data management to resolve queries on discrepant data.
Assist with efforts to recruit investigative sites to participate in clinical studies.
Comply with ICH GCP guidelines, FDA regulations, and company SOPs.
Participate in internal, client/sponsor, scientific, and other meetings as required.
Manage and resolve conflicting priorities to deliver on commitments.
Perform 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 Demands Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
Languages English
Education Bachelor of Science (BS)
Contract Type Regular
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