FSP - Sr. CRA - Oncology - Texas, Central & Mid-West

Role Summary

We are currently seeking experienced Oncology CRAs residing in the Central & Mid-West US to join our FSP team. The Senior CRA I is responsible for site monitoring and site management, ensuring implementation of project plans, and may function as a Local Project Coordinator or Lead CRA as assigned.

Responsibilities

• The statements below describe the general nature of the job and are not an exhaustive list of responsibilities, skills, and duties.
• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Protect study patients by verifying informed consent procedures and protocol requirements adhere to regulatory requirements.
• Ensure data integrity on CRFs or other data collection tools by source document review.
• Monitor data for missing or implausible data.
• Use sponsor and Fortrea resources efficiently, including managing travel expenses per Fortrea travel policy.
• Audit readiness at the site level.
• Travel (air travel) may be required and is an essential function of the job.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director as assigned.
• Serve as lead monitor for a protocol or project and assist in monitoring plan development and trip report review as assigned.
• Review progress of projects and initiate actions to achieve objectives.
• Organize and present at Investigator Meetings.
• Participate in developing protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other vendors as assigned.
• Responsible for all aspects of registry management as prescribed in project plans.
• Undertake feasibility work when requested.
• Conduct, report, and follow-up on QC visits when requested.
• Recruitment of investigators, EC submissions, regulatory notifications, document translation, meeting organization, and other tasks as instructed.
• Negotiate study budgets with investigators and assist with statements of agreements as assigned.
• Track and follow-up on SAE reporting, and produce related reports and narratives.
• Independently perform CRF review; query generation and resolution per data review guidelines.
• Assist with training, mentoring, and development of new staff.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision if applicable), and may act as a local client contact as assigned.
• Perform other duties as assigned by management.
• All other duties as needed or assigned.

Qualifications

• Minimum: University/college degree (life science preferred) or related allied health certification; or 3 years of relevant clinical research experience in pharma/CRO.
• Thorough knowledge of regulatory requirements and drug development process.
• Fluent in local language and English (written and verbal).

Experience

• Minimum 3 years of Clinical Monitoring experience.
• Understanding of SAE reporting and related documentation.
• Advanced site monitoring, study site management, and registry administration skills.
• Ability to work with minimal supervision; strong planning, organization, and communication skills.
• Ability to train and supervise junior staff; work effectively in a matrix environment.
• Valid Driver's License.

Preferred Qualifications

• 1+ year additional experience in related field (medical, clinical, pharmaceutical, etc.).
• Local project coordination and/or project management experience.

Additional Requirements

• Travel requirements: 60-80% overnight.
• Office/Home-Based; occasional travel domestic and international.
• Physical demands: standard office environment with occasional lifting up to 15-20 lbs.