Sr CRA II

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate, navigation, EEO, etc. Must preserve all substantive info. We need to parse the posting. Key info: - Title: Sr Clinical Research Associate II (but not used as heading) - Location: West Coast located near major cities in CA, NV, CO, UT, and AZ - Travel: Regionally aligned for West Coast Travel up to 80% if needed - Contract / Length: Full time, 6 months with potential to extend or convert to permanent. - Pay: W-2 hourly between $58.00 – $64.90 an hour/door to door (limited benefit options) - Must have experience: Complex therapeutic monitoring experience (i.e., oncology, neurology, CAR-T, Rare Dease); Contract or project support experience; Large CRO monitoring experience. - Kelly Science and Clinical is hiring on behalf of one of our large CRO clients to support a six-month project with the potential for future extension. We are seeking experienced CRA monitors to support regional studies at sites across the West Coast. Ideal candidates have monitored complex therapeutic studies for CROs in the past and can work independently with minimal onboarding. The average workload consists of 2–3 studies and 10–12 sites, though this may fluctuate based on project needs. The position requires flexibility to travel up to 80% (both driving and flying) to sites within the West region. The CRA II performs and coordinates all aspects of clinical monitoring and site management. This role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation across various monitoring environments (e.g., FSO, FSP, Government). As a site processes specialist, the CRA II ensures trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability while ensuring audit readiness. The CRA II develops collaborative relationships with investigational sites and client personnel and may assist Project Managers or Clinical Team Managers with project tasks or mentoring junior team members. Detailed tasks and responsibilities are outlined in the project task matrix. - Essential Functions list (many bullet points) - Education and Experience: Bachelor’s degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification. 3+ years of previous on-site monitoring experience required. Prior experience working within a large CRO is required. Previous CRA contracting experience required. Valid driver’s license. - Knowledge, Skills, and Abilities: list many items. - Benefits: Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. (Note: limited benefit options mentioned earlier but Kelly benefits described) - Pay: W-2 hourly between $58.00 – $64.90 an hour/door to door (limited benefit options) - Schedule: Not explicitly given; travel up to 80% maybe schedule? Not explicit schedule like full-time. Could infer full-time. But we should only include Schedule if posting actually states it. It does not state schedule like "Monday-Friday" etc. So we should not create Schedule section. - Benefits: we have content. So include Benefits section. - Pay: we have content. Include Pay. - About the role: we have description of role, location, travel, contract length, workload, etc. That fits. - Responsibilities: we have Essential Functions list (detailed tasks). That is responsibilities. - Requirements: we have Must have experience, Education and Experience, maybe also qualifications. - Qualifications: could be Education and Experience? Might overlap. But we need to decide sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to avoid duplication. We can map: - About the role: location, travel, contract length, overview. - Responsibilities: Essential Functions list (the bullet points under "Essential Functions"). - Requirements: Must have experience (Complex therapeutic monitoring experience, Contract or project support experience, Large CRO monitoring experience) plus Education and Experience (Bachelor's degree, 3+ years on-site monitoring, prior large CRO experience, previous CRA contracting experience, valid driver's license). Also maybe "Must have experience" is part of requirements. - Qualifications: Could be the same as Requirements? Might be redundant. Perhaps we can treat Requirements as the mandatory experience, and Qualifications as education/credentials. But we need to avoid filler. Let's see if we can separate: Requirements: "Must have experience: Complex therapeutic monitoring experience (i.e., oncology, neurology, CAR-T, Rare Dease); Contract or project support experience; Large CRO monitoring experience." Qualifications: "Education and Experience: Bachelor’s degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification. 3+ years of previous on-site monitoring experience required. Prior experience working within a large CRO is required. Previous CRA contracting experience required. Valid driver’s license." - Skills: Knowledge, Skills, and Abilities list. - Benefits: Kelly benefits description. - Pay: W-2 hourly between $58.00 – $64.90 an hour/door to door (limited benefit options). - Schedule: Not present, so omit. We must not include boilerplate like EEO, etc. Also remove duplicated lines. We need to output only HTML fragment, using

for section headings,

• for any list of duties/requirements/benefits, and

  for prose. We need to preserve all substantive information; do not invent or summarize away detail. We need to ensure we include all details from the posting that are substantive. Let's extract details: About the role: - Sr Clinical Research Associate II (title not used as heading) - Location: West Coast located near major cities in CA, NV, CO, UT, and AZ - Travel: Regionally aligned for West Coast Travel up to 80% if needed - Contract / Length: Full time, 6 months with potential to extend or convert to permanent. - Workload: average workload consists of 2–3 studies and 10–12 sites, though may fluctuate based on project needs. - The position requires flexibility to travel up to 80% (both driving and flying) to sites within the West region. - The CRA II performs and coordinates all aspects of clinical monitoring and site management. - Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation across various monitoring environments (e.g., FSO, FSP, Government). - As a site processes specialist, ensures trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability while ensuring audit readiness. - Develops collaborative relationships with investigational sites and client personnel and may assist Project Managers or Clinical Team Managers with project tasks or mentoring junior team members. - Detailed tasks and responsibilities are outlined in the project task matrix. We need to include all that in About the role section as prose (maybe some bullet? but it's not a list; we can use

  paragraphs). Responsibilities: Essential Functions list (the bullet points). Let's capture each bullet: - Site Monitoring & Compliance: Monitors investigator sites using a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions (CAPA). - Data Integrity: Ensures data accuracy through Source Document Review (SDR), Source Document Verification (SDV), and Case Report Form (CRF) review during on-site and remote monitoring visits. - IP Management: Assesses investigational products through physical inventory checks and records reviews. - Documentation & Reporting: Documents observations in reports and follow-up letters in a timely manner using professional business writing standards. - Issue Escalation: Escalates observed deficiencies to clinical management expeditiously and follows all issues through to resolution. - Site Relations & Communication: Maintains regular contact with investigative sites between visits to confirm protocol compliance, track issue resolution, and ensure timely data entry. Facilitates effective communication between sites, client management, and the project team. - Trial Execution: Conducts monitoring tasks in accordance with approved monitoring plans, assists with the investigator payment process, and participates in investigator meetings as needed. - Site Selection & Initiation: Collaborates with the client team to identify qualified investigators, initiates clinical trial sites according to relevant procedures, and makes recommendations as warranted. - Study Close-Out: Oversees trial close-out procedures and the retrieval of trial materials. - Regulatory & Essential Documents: Ensures required essential documents are complete, accurate, and filed according to ICH-GCP guidelines and applicable regulations. Conducts on-site file reviews per project specifications. - Team Contribution & Mentorship: Mentors new team members, assists in preparing project tools (e.g., informed consents, CRF guidelines, monitoring plans), and provides project-specific training to the clinical team as needed. - Process Improvement: Identifies opportunities for process improvement and shares actionable solutions with management. - Cross-Functional Support: Performs additional tasks as assigned by the Clinical Team Manager (CTM) or Clinical Manager of CRAs (CM-CRA), such as trip report reviews, newsletter creation, and leading CRA team calls. - Tracking & Systems: Provides trial status updates and progress reports to the CTM. Updates study management systems (e.g., CTMS) per agreed conventions and performs QC checks on CTMS reports as required. - Audits & Quality Assurance: Responds to company, client, and regulatory body requirements, audits, and inspections. Ensures audit readiness across assigned sites. - Administrative: Completes administrative tasks, including expense reports and timesheets, in a timely manner. We need to output each as

• under a
  . The heading for Responsibilities:

  Responsibilities

  . Requirements: Must have experience list (three items). Also maybe include "Must have experience: Complex therapeutic monitoring experience (i.e., oncology, neurology, CAR-T, Rare Dease); Contract or project support experience; Large CRO monitoring experience." That's a sentence with semicolons. We can split into list items. Qualifications: Education and Experience list: Bachelor’s degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification. 3+ years of previous on-site monitoring experience required. Prior experience working within a large CRO is required. Previous CRA contracting experience required. Valid driver’s license. We could split each as list items. Skills: Knowledge, Skills, and Abilities list: many items. Let's extract them: - Strong clinical monitoring skills across full study lifecycles. - Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. - In-depth understanding and practical application of ICH-GCP, applicable global regulations, and procedural documents. - Advanced critical thinking, root cause analysis, and problem-solving abilities. - Demonstrated proficiency with Risk-Based Monitoring (RBM) concepts and tools. - Strong written and oral communication skills, with the ability to interact professionally with medical personnel and site staff. - Excellent customer service skills, active listening abilities, and strong attention to detail. - Strong organizational, interpersonal, and time-management skills. - Ability to remain flexible and adaptable in dynamic environments. - Proven ability to work effectively both independently and within a cross-functional team. - Proficiency in computer applications, including MS Office, EDC, and CTMS platforms. - Strong English language and grammar skills. - Confident presentation and facilitation skills. We'll list each as
  • . Benef