**Clinical Study Site Monitor**

We are seeking a highly motivated and organized Clinical Study Site Monitor to join our team at Fortrea.

As a Clinical Study Site Monitor, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaise with vendors, and other duties as assigned.

Key Responsibilities:

• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Prepare accurate and timely trip reports.
• Manage small projects under direction of a Project Manager/Director as assigned.
• Serve as lend monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned.
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Organize and make presentations at Investigator Meetings.
• Participate in the development of 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 supplies (vendors) as assigned.
• Responsible for all aspects of registry management as prescribed in the project plans.
• Undertake feasibility work when requested.
• Conduct, report, and follow-up on Quality Control Visit (CQC) when requested.
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned.
• Negotiate study budget with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or clinical data management system assigned by management.
• Assist with training, mentoring, and development of new employees, e.g., co-monitoring.
• Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contacts as assigned.
• Perform other duties as assigned by management.

This role requires excellent communication skills, attention to detail, and ability to work independently with minimal supervision. You will have the opportunity to work on various clinical trials and develop your skills and knowledge in clinical research.

Requirements:

• Bachelor's degree in a life science or related field.
• Minimum 2 years of experience in clinical research, preferably in study site monitoring.
• Excellent communication and interpersonal skills.
• Ability to work independently with minimal supervision.
• Strong attention to detail and organizational skills.
• Ability to travel up to 50% of the time.

What We Offer:

• Competitive salary: $65,000 - $85,000 per year.
• Opportunity to work on various clinical trials and develop your skills and knowledge in clinical research.
• Collaborative and dynamic work environment.
• Professional development opportunities.