Job Description

We believe in the power of partnership to fuel insights and unlock new possibilities. We offer our customers a tailored approach to clinical trial solutions through the use of three delivery models: full service, functional service providers, or a hybrid approach. We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. With our 30-year history, Fortrea\'s team of more than 19,000 professionals partner with emerging and large biopharma, medical device, and diagnostic companies to support operations and drive healthcare innovation, advancing life-saving therapies for patients in nearly 100 countries.

Key accountabilities will include (but not limited to)

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

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

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 Covance 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 Covance travel policy

Ensure audit readiness at the site level

Travel, including air travel, may be required and is an essential function of the job.

Prepare accurate and timely trip reports

Manage small projects under direction of a Project Manager/Director as assigned

Serve as lead 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 suppliers (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 (QC) visits 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 budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g. co-monitoring

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

About you

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately

Full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Advanced site monitoring skills

Advanced study site management skills

Advanced registry administration skills

Ability to work with minimal supervision

Good planning and organization skills

Good computer skills with good working knowledge of a range of computer packages

Advanced verbal and written communication skills

Ability to train and supervise junior staff

Ability to resolve project-related problems and prioritizes workload for self and team

Ability to work within a project team

Works efficiently and effectively in a matrix environment

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023. We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our .

Labcorp