Senior CRA

Senior Clinical Research Associate I (Sr CRA I)

6 month contract - renewable or conversion to PERM after 6 months

Paid for all hours (travel included) - door to door

Benefits included (w2 only)

The Senior Clinical Research Associate I performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. This role conducts remote and on-site monitoring visits to assess protocol and regulatory compliance, ensures high-quality documentation, and supports trials across multiple sponsor models and monitoring environments. The Sr CRA I acts as a site process specialist, ensuring that studies are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures to safeguard participant rights, well-being, and data integrity. The position emphasizes audit readiness, strong collaboration with investigational sites, and effective communication with project teams in a dynamic, global clinical research environment.

Responsibilities

• Perform comprehensive clinical monitoring and site management activities for assigned clinical trials, both remotely and on-site.
• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify site process failures and implement corrective and preventive actions.
• Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review during on-site and remote monitoring activities.
• Assess investigational product accountability through physical inventory checks and records review, ensuring compliance with protocol and regulatory requirements.
• Document monitoring observations in clear, timely reports and correspondence using approved business writing standards, and ensure all documentation meets audit readiness expectations.
• Escalate site deficiencies, risks, and issues promptly to clinical management and follow all findings through to full resolution in collaboration with project team members.
• Maintain regular contact with investigational sites between monitoring visits, as needed, to confirm protocol adherence, verify resolution of previously identified issues, and support timely and accurate data entry.
• Conduct monitoring tasks in strict accordance with the approved monitoring plan and study-specific procedures.
• Participate in the investigator payment process, ensuring accurate tracking and appropriate follow-up on payment-related matters.
• Share responsibility with project team members for issue and finding resolution, investigating and following up on site-related concerns as applicable.
• Provide trial status tracking and progress updates to the Clinical Team Manager and update study systems, including Clinical Trial Management Systems (CTMS), according to agreed study conventions.
• Perform quality control checks of reports generated from CTMS or other study systems when required to ensure data accuracy and completeness.
• Participate in investigator meetings as needed, supporting site training, protocol clarification, and study start-up activities.
• Identify potential investigators in collaboration with sponsor teams to evaluate and recommend qualified investigational sites.
• Initiate clinical trial sites according to relevant procedures, ensuring compliance with the protocol, regulatory requirements, and ICH-GCP obligations, and make recommendations where warranted.
• Ensure proper trial close-out at assigned sites, including retrieval of trial materials and confirmation that essential activities are completed.
• Verify that required essential documents are complete, current, and appropriately filed in accordance with ICH-GCP and applicable regulations.
• Conduct on-site file reviews as specified in project requirements to ensure documentation quality and regulatory compliance.
• Contribute to project teams by assisting in the preparation of project publications, tools, and communications, and by sharing ideas and suggestions for improved processes.
• Perform additional study-related tasks as assigned by clinical leadership, such as reviewing trip reports, creating newsletters, and leading CRA team calls to support study oversight.
• Facilitate effective communication between investigative sites, sponsor representatives, and the project team through clear written, oral, and electronic correspondence.
• Respond to company, sponsor, and regulatory requirements, including audits and inspections, by providing accurate information and supporting corrective actions as needed.
• Complete administrative tasks such as expense reports and timesheets accurately and on time.
• Contribute to other project work and continuous process improvement initiatives as required, supporting operational excellence across studies.

Essential Skills

• Bachelor's 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 of experience as a clinical research monitor.
• Valid driver's license where applicable to support required travel.
• Effective clinical monitoring skills, including on-site and remote monitoring of investigational sites.
• Demonstrated understanding of medical and therapeutic area concepts and medical terminology, including experience in clinical research, oncology, and CNS studies.
• Excellent understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents.
• Strong critical thinking abilities, including an investigative mindset, thorough root cause analysis, and effective problem-solving skills.
• Ability to manage and apply risk-based monitoring concepts and processes in day-to-day monitoring activities.
• Effective oral and written communication skills, with the ability to communicate clearly and professionally with medical personnel and project stakeholders.
• Strong attention to detail, ensuring accuracy in documentation, data review, and reporting.
• Effective organizational and time management skills, with the ability to prioritize tasks and manage multiple responsibilities.
• Ability to remain flexible and adaptable across a wide range of scenarios, studies, and monitoring environments.
• Ability to work both independently and as part of a collaborative project team.
• Good computer skills, including proficient use of Microsoft Office applications and the ability to learn and use clinical trial software systems such as CTMS.
• Strong English language and grammar skills, supporting high-quality written reports and presentations.
• Good presentation skills, enabling effective participation in investigator meetings and team discussions.

Additional Skills & Qualifications

• Experience working with different sponsor models and monitoring environments, including functional service organizations (FSO), functional service providers (FSP), and government-sponsored studies.
• Familiarity with clinical research processes in global contract research organizations and exposure to diverse therapeutic areas.
• Ability to build and maintain collaborative relationships with investigational sites and project team members.
• Experience contributing to project tools and publications, such as newsletters and study-related communications.
• Capability to lead or support CRA team calls and contribute to team coordination efforts.
• Demonstrated customer focus, including strong listening skills, attention to detail, and the ability to recognize and address underlying site and sponsor needs.
• Willingness to engage in continuous learning and process improvement initiatives to enhance study quality and efficiency.
• In some cases, a combination of appropriate education, training, and directly related experience may be considered equivalent to formal degree requirements.

Work Environment

This position is 100% home-based, offering the flexibility to work remotely while supporting clinical trials across multiple regions. The role requires significant travel, with an estimated 6080% travel commitment and an average of 810 overnight monitoring visits per month to investigational sites. Work is conducted using standard office technology, including Microsoft Office and clinical trial management systems, in a professional environment focused on collaboration, regulatory compliance, and high-quality data. The culture emphasizes partnership with leading pharmaceutical and biotechnology organizations, exposure to diverse therapeutic areas, and participation in a global clinical research setting.

Job Type & Location

This is a Contract position based out of Houston, TX.

Pay and Benefits

The pay range for this position is $58.62 - $62.07/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 Deadline

This position is anticipated to close on Oct 28, 202