Job Title: Clinical Research Associate (CRA) Central or West RegionJob DescriptionThis role performs and coordinates all aspects of clinical monitoring and site management for sponsored clinical trials. You will conduct remote and on-site monitoring visits to assess protocol and regulatory compliance, manage essential documentation, and ensure that studies are conducted in accordance with ICH-GCP guidelines, applicable regulations, and internal standard operating procedures. As a site process specialist, you will help safeguard participant rights and well-being, support data accuracy and reliability, and maintain audit readiness while building strong, collaborative relationships with investigational sites.

Responsibilities

Perform comprehensive clinical monitoring and site management activities for assigned clinical trials, both remotely and on-site.
Conduct monitoring visits using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and define corrective and preventive actions.
Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review, in line with the approved monitoring plan.
Assess investigational products through physical inventory checks and review of related records to confirm proper handling and accountability.
Document all observations, findings, and follow-up actions in monitoring reports and correspondence using approved business writing standards and submit these in a timely manner.
Escalate site deficiencies, non-compliance issues, and risks to clinical management promptly and track all issues through to resolution in collaboration with the project team.
Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, verify resolution of previously identified issues, and ensure timely and accurate data entry.
Participate in the investigator payment process in accordance with study procedures and sponsor requirements.
Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) or project leadership as required.
Update study systems, including the Clinical Trial Management System (CTMS), following agreed study conventions and perform quality control checks of system-generated reports when needed.
Participate in investigator meetings as required, supporting site engagement and study start-up activities.
Collaborate in identifying potential investigators and evaluating site suitability to ensure the acceptability of qualified investigative sites.
Initiate clinical trial sites following relevant procedures to ensure compliance with the protocol, regulatory requirements, and ICH-GCP obligations, making recommendations when appropriate.
Ensure trial close-out activities are completed, including retrieval of trial materials and confirmation that essential documentation is finalized and filed.
Verify that required essential documents are complete, accurate, and maintained in accordance with ICH-GCP and applicable regulations, including conducting on-site file reviews as specified by the project.
Contribute to project deliverables by assisting in the preparation of study publications, tools, newsletters, and other project-related materials.
Lead or participate in CRA team calls when assigned, and facilitate effective communication between investigative sites, the sponsor, and the broader project team through written, oral, and electronic channels.
Respond to company, sponsor, and regulatory requirements, including audits and inspections, by providing documentation and information and supporting corrective actions.
Complete administrative tasks such as expense reports and timesheets accurately and within required timelines.
Support other project work and process improvement initiatives as needed, sharing ideas and best practices with colleagues.

Essential Skills

Bachelors degree in a life sciences-related field, a Registered Nursing certification, or an equivalent and relevant formal academic or vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the role, comparable to at least 2+ years as a clinical research monitor or Clinical Research Associate.
Valid drivers license where applicable to support required travel.
Effective clinical monitoring skills, including experience conducting remote and on-site visits and managing essential trial documentation.
Strong understanding of medical and therapeutic areas and proficiency with medical terminology.
Excellent knowledge and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents.
Well-developed critical thinking skills, including the ability to perform in-depth investigations, conduct root cause analysis, and implement appropriate problem-solving strategies.
Ability to manage and apply Risk Based Monitoring concepts and processes in daily monitoring activities.
Effective oral and written communication skills, with the ability to communicate clearly and professionally with medical and clinical personnel.
Strong attention to detail and accuracy in reviewing data, documentation, and reports.
Effective organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
Ability to remain flexible and adaptable across a wide range of study scenarios and changing priorities.
Ability to work both independently with minimal supervision and collaboratively within cross-functional teams.
Proficient computer skills, including strong knowledge of Microsoft Office and the ability to learn and use clinical trial-related software and systems such as CTMS.
Good command of the English language, including grammar, for professional communication and report writing.
Confident presentation skills for investigator meetings and internal team discussions.

Additional Skills & Qualifications

Experience working within different sponsor models or monitoring environments, such as functional service provider (FSO/FSP) arrangements and government-sponsored studies.
Familiarity with Trial Master File (TMF) requirements and documentation practices.
Experience with risk-based monitoring methodologies and tools.
Background in a global contract research or clinical research organization environment.
Ability to maintain strong customer focus through attentive listening, attention to detail, and the ability to understand and address underlying site and sponsor needs.
Strong interpersonal skills that support effective collaboration with site staff, project teams, and stakeholders.
Experience contributing to project publications, tools, newsletters, and other study-related communications.
Experience participating in or supporting audits and inspections, including preparation of documentation and responses.
Equivalency of education, training, and directly related experience may be considered in lieu of formal degree requirements.

Work EnvironmentThis is a 100% home-based position within the United States, offering flexibility to work from your home office while supporting clinical trial sites across the West region. The role requires frequent travel, typically in the range of 6080%, for on-site monitoring visits, site initiation, close-out activities, and investigator meetings. You will use standard office technology, including a computer with Microsoft Office and clinical trial systems such as CTMS, along with secure electronic communication tools to collaborate with sites and project teams. Travel may involve varying schedules depending on study needs, and you will work within a professional, process-driven environment focused on regulatory compliance, data quality, and continuous improvement.

Job Type & LocationThis is a Contract position based out of Kansas City, MO.

Pay and BenefitsThe pay range for this position is $70.00 - $95.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision

Critical Illness, Accident, and Hospital

401(k) Retirement Plan Pre-tax and Roth post-tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick Leave)

Application DeadlineThis position is anticipated to close on Nov 20, 2026.

Workplace TypeThis is a fully remote position. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Sr CRA II @ Actalent

About this role