Senior Clinical Research Associate I

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to parse the posting. Job title: Clinical Research Associate I. Not to repeat as heading. Location: Remote / Home office located near major cities in CA, NV, CO, UT, or AZ. Travel: Regionally aligned for West Coast travel (up to 80% as needed). Employment Type: W-2 hourly, full-time contract (6 months with potential to extend). Pay Rate: $55.86 – $62.07/hour door-to-door (limited benefits options available). Summarized Purpose etc. We need to extract sections: - About the role: likely the summarized purpose paragraph: "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 looking for strong CRA monitors to support regional studies at sites across the West Coast. Ideal candidates will have at least two years of experience monitoring complex therapeutic studies, with prior large CRO experience preferred. The CRA I performs and coordinates all aspects of the clinical monitoring and site management process. 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 I 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 maintaining audit readiness. The CRA I develops collaborative relationships with investigational sites and project team members. Detailed tasks and responsibilities are outlined in the project task matrix." That's a good About the role. - Responsibilities: The list of essential functions (Site Monitoring & Compliance, Data Integrity, IP Management, Documentation & Reporting, Issue Escalation, Site Relations & Follow-Up, Trial Execution, Tracking & Systems, Site Selection & Initiation, Study Close-Out, Regulatory & Essential Documents, Team Contribution, Study Tasks & Leadership, Stakeholder Communication, Audits & Quality Assurance, Administrative, Process Improvement). We can put these as bullet list items. - Requirements: Education And Experience: Bachelor’s degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification. 2+ years of experience as a clinical research monitor or equivalent experience demonstrating the necessary knowledge, skills, and abilities. Prior monitoring experience complex therapeutic areas, with large CRO experience preferred. Valid driver’s license. - Qualifications: Might be overlapping with Requirements; but we can treat Qualifications as maybe the same? The instruction says use sections only if posting has real specific content. The posting has "Education And Experience" and "Knowledge, Skills, And Abilities". So we could map: - Requirements: Education And Experience (maybe also driver's license) - Qualifications: Knowledge, Skills, And Abilities (maybe also other specifics) - Skills: Could be derived from Knowledge, Skills, And Abilities but we already have that. However we need to decide which sections to include. We have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have content for: - About the role: yes. - Responsibilities: yes (essential functions list). - Requirements: Education And Experience (degree, experience, driver's license). Yes. - Qualifications: Knowledge, Skills, And Abilities (list). Yes. - Skills: Could be a subset but we already have Knowledge, Skills, And Abilities; maybe we can combine? But we need to avoid duplication. Perhaps we can put Skills as a subsection of Knowledge, Skills, And Abilities? But the instruction says use sections only when posting has real specific content. The posting includes a list under "Knowledge, Skills, And Abilities". That could serve as Skills section. However we also have Qualifications maybe for education/experience. Let's decide: - Requirements: Education And Experience (degree, experience, driver's license) - Qualifications: Knowledge, Skills, And Abilities (the list) - Skills: maybe we could omit because it's covered; but we need to include only if posting has real specific content. The posting does have a list of skills/abilities; we could treat that as Skills. But then Qualifications would be something else? The posting doesn't have a separate "Qualifications" heading besides Education And Experience. So we could map: Requirements: Education And Experience Qualifications: (maybe not present) -> skip Skills: Knowledge, Skills, And Abilities However the instruction says use sections only when posting has real specific content. So we can skip Qualifications if not present. But we also have Benefits: The posting mentions 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. Also retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), transit spending account, paid sick leave. So we have benefits content. Pay: Pay Rate: $55.86 – $62.07/hour door-to-door (limited benefits options available). So we have pay. Schedule: Not explicitly given; there is travel up to 80% as needed, employment type full-time contract (6 months). No explicit schedule like hours per week. Could infer full-time but not explicit. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. Schedule not stated explicitly; we should not create Schedule section. Thus sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay. We need to use

for section headings. Use

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

  for prose. We must not repeat job title as heading. Do not put Job ID/requisition numbers as headings. We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate etc. We need to output only HTML fragment. Let's craft:

  About the role

  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 looking for strong CRA monitors to support regional studies at sites across the West Coast. Ideal candidates will have at least two years of experience monitoring complex therapeutic studies, with prior large CRO experience preferred. The CRA I performs and coordinates all aspects of the clinical monitoring and site management process. 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 I 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 maintaining audit readiness. The CRA I develops collaborative relationships with investigational sites and project team members. Detailed tasks and responsibilities are outlined in the project task matrix.

  Responsibilities

  • 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) to bring sites into compliance.
  • 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 activities.
  • 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 & Follow-Up: Maintains regular contact with investigative sites between visits to confirm protocol adherence, track issue resolution, and ensure timely data entry.
  • Trial Execution: Conducts monitoring tasks in accordance with the approved monitoring plan, assists with the investigator payment process, and participates in investigator meetings as needed.
  • Tracking & Systems: Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM). Updates study systems (e.g., CTMS) per agreed study conventions and performs QC checks on CTMS-generated reports as required.
  • Site Selection & Initiation: Collaborates with the client company 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: Contributes to the project team by assisting in the preparation of project publications and tools, as well as sharing actionable ideas and suggestions with team members.
  • Study Tasks & Leadership: Performs additional study tasks assigned by the CTM, such as trip report reviews, newsletter creation, and leading CRA team calls.
  • Stakeholder Communication: Facilitates effective communication between investigative sites, the client company, and the project team through written, oral, and electronic channels.
  • Audits & Quality Assurance: Responds to company, client, and applicable regulatory requirements, audits, and inspections.
  • Administrative: Completes administrative tasks, including expense reports and timesheets, in a timely manner.
  • Process Improvement: Contributes to project initiatives and process improvement efforts as required.

  Requirements

  • Bachelor’s degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification.
  • 2+ years of experience as a clinical research monitor or equivalent experience demonstrating the necessary knowledge, skills, and abilities.
  • Prior monitoring experience in complex therapeutic areas, with large CRO experience preferred.
  • Valid driver’s license.

  Skills

  • Effective clinical monitoring skills across full study lifecycles.
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  • Strong understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents.
  • Well-developed critical thinking skills, including root cause analysis (RCA) and proactive problem-solving.
  • Ability to apply Risk-Based Monitoring (RBM) concepts and processes.
  • Clear oral and written communication skills with the ability to interact effectively with medical personnel and site staff.
  • Strong customer focus with active listening skills, high attention to detail, and the ability to address underlying customer needs.
  • Excellent interpersonal, organizational, and time-management skills.
  • Ability to remain flexible and adaptable across a range of study scenarios.
  • Proven ability to work effectively both independently and as part of a collaborative team.
  • Computer proficiency, including Microsoft Office applications, with the ability to quickly learn EDC and CTMS platforms.
  • Strong English language and grammar skills.
  • Effective presentation and communication skills.

  Benefits

  • Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
  • Retirement savings plan.
  • Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
  • Transit spending account.