Job Description

The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

Essential Job Duties:
1) The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
2) 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
3) Responsible for all aspects of site management as prescribed in the project plans
4) General On-Site Monitoring Responsibilities
5) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
6) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
8) Monitor data for missing or implausible data
9) 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
10) Ensure audit readiness at the site level
11) Travel, including air travel, may be required and is an essential function of the job.
12) Prepare accurate and timely trip reports
13) Responsible for all aspects of registry management as prescribed in the project plans
14) Undertake feasibility work when requested
15) Participate in and follow up on Quality Control Visits (QC) when requested
16) 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
17) Might be requested to work in a client facing environment
18) Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
19) Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
20) Assist with training, of new employees, e.g. co-monitoring
21) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
22) Perform other duties as assigned by management

Experience Minimum Required:

• A minimum of 2 year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.

• Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines

• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

• Good planning, organization and problem-solving abilities

• Ability to work with minimal supervision

• Good communication and interpersonal skills

• Good analytical and negotiation skills

• Computer competency

• Fluent in local office language and in English, both written and verbal

• Works efficiently and effectively in a matrix environment

Education Minimum Required:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

• Thorough knowledge of monitoring procedures

• Basic understanding of the clinical trial process

• Valid Driver\'s License

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp\'s Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea\xe2\x80\x99s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit .

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.

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