Jobs · Analyst · Massachusetts

Sr. In-house Clinical Research Associate

Alira Health · Framingham, MA · 1 mo ago
AnalystFull-time
We need to output HTML fragment with sections for headings where content exists. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. We must not include Job ID etc. Remove boilerplate: referral link, etc. Keep substantive info. We need to parse the posting. Content: - Intro: "Join our global team dedicated to innovation and initiative..." That's about the role/company culture. Could be "About the role" or maybe "About the role". We'll put that in

About the role

with

. - Job Description Summary: "Job Description 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." That's description of role; could be part of About the role or Responsibilities. We'll treat as About the role. - Essential Job Functions: list of duties. That's Responsibilities. List items: 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 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 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 That's responsibilities. - Preparation, Knowledge, Skills & Abilities: list of qualifications/skills. Items: 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. We need to split into sections: Requirements, Qualifications, Skills. The instruction says use headings for those categories. We need to decide what goes where. Typically: - Requirements: maybe education, experience, work authorization. - Qualifications: maybe specific abilities like detail-oriented, organizational, etc. - Skills: technical skills like MS Office, communication, etc. But we must not invent content; we just need to map existing bullet points to headings. We can create sections based on logical grouping. We have: Education/Experience: BS/BA or equivalent experience; At least 7 years experience; Permanent authorization to work in the U.S. These could go under Requirements. Then "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" could go under Skills or Qualifications. "Proficient with MS Office Suite, particularly Word and Excel" could be Skills. We need to avoid empty sections. We'll create:

Requirements

with
    for education/experience/work auth.

    Skills

    with
      for the rest (including MS Office, communication, etc.) We could also have

      Qualifications

      but maybe not needed if we already have Skills covering. However instruction: "Prefer a few substantive sections over many thin ones." So we can combine Qualifications and Skills into one Skills section. But we have headings list includes Qualifications and Skills; we can choose to use Skills only if we have content. We'll not create Qualifications if we don't have distinct content. We also have 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." Could be a section? Not in headings list; but we could put under About the role or maybe a separate section not listed? The instruction says use headings for those specific headings; we shouldn't create other headings. So we can incorporate that into About the role paragraph or maybe a

      under About the role. Languages: English. Could be part of Requirements or Skills. We'll add to Skills maybe. Education: Bachelor of Science (BS) - already covered. Contract Type: Regular - could be part of About the role or maybe not needed. It's minor metadata; we can fold into short

      or drop. Probably include in About the role paragraph. Salary Range: "The 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". This is Pay info. So we need a Pay section with that content. According to rules: include Pay section only if posting actually states them. Yes, they state salary range. So we create

      Pay

      with

      containing that sentence. Schedule: Not mentioned. So we omit Schedule section. Benefits: Not mentioned. Omit Benefits. Now About the role: we need to include intro paragraph about global team, values, etc. Also maybe mention contract type regular. We'll combine. Let's craft:

      About the role

      Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. The Sr. In-house Clinical Research Associate (CRA) is an important member of the Alira Health Clinical team, managing and supporting clinical sites from site approval through close-out, working closely with field CRAs and Clinical Project Managers to ensure trial data integrity without frequent travel. This is a regular contract position.

      We could also add working conditions: maybe add a sentence: "Normal office working conditions with frequent sitting, standing, bending, twisting, and computer monitor use; occasional lifting up to 30 lbs." We'll add to same paragraph. Now Responsibilities:

      Responsibilities

      with
      • ... each duty. Now Skills:

        Skills

        with
        • items. We need to ensure we don't repeat content. Let's list skills items: - BS/BA from an undergraduate program or equivalent experience (maybe education, but we already have education in Requirements; we could keep it there.) But we said Requirements will have education/experience/work auth. So we should not duplicate. Thus Skills items: - 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. (maybe that's requirement, but we already have it in Requirements; we can keep it there only.) - Languages: English (maybe include) We could also include "Bachelor of Science (BS)" but that's education. Thus Requirements: - BS/BA from an undergraduate program or equivalent experience - At least 7 years of experience in clinical research - Permanent authorization to work in the U.S. - Languages: English (maybe) But languages could be skill; but we can put in Requirements as well. We need to avoid duplication. Let's decide: Requirements: education, years experience, work authorization, language. Skills: the rest (detail-oriented, organizational, analytical, leadership, self-starter, problem-solving, communication, MS Office). We'll also include "Bachelor of Science (BS)" maybe as part of education. Now Pay section:

          Pay

          The 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

          Now we need to ensure we don't include any boilerplate like referral link, EEO, etc. We removed. Now output only HTML fragment. Let's construct. Check for any missing substantive info: The "Job Description Summary" we incorporated. The "Essential Job Functions" we made responsibilities. The "Preparation, Knowledge, Skills & Abilities" we split. The "WORKING CONDITIONS/PHYSICAL DEMANDS" we added to About the role. The "Languages English" we added to Requirements. The "Education Bachelor of Science (BS)" we added to Requirements. The "Contract Type Regular" we added to About the role. The "Salary Range" we added to Pay. All good. Now produce HTML. Be careful to escape any special characters like & etc. In the text we have “and” etc. Use plain text. We'll output:

          About the role

          Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. The Sr. In-house Clinical Research Associate (CRA) is an important member of the Alira Health Clinical team, managing and supporting clinical sites from site approval through close-out, working closely with field CRAs and Clinical Project Managers to ensure trial data integrity without frequent travel. This is a regular contract position. Normal office working conditions include frequent sitting, standing, bending, twisting, and computer monitor use; occasional lifting of up to 30 lbs.

          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 site-specific ICFs
          • Responds to sites

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