Job Overview:
Site monitoring and site management responsibility for UNBLINDED clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned.
Summary of Responsibilities:
- Primarily responsible for supporting unblinded monitoring activities for FSP MSD clinical studies.
- 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.
- 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.
- 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.
- 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.
- Participate in and follow-up on Quality Control Visits (QC) 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 18) Assist Senior CRA with managing investigator site budgets.
- 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 Fortrea 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.
Qualifications (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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Basic knowledge of Regulatory Guidelines.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
Experience (Minimum Required):
- Six (6) months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.).
- Basic understanding of Regulatory Guidelines.
- Ability to work within a project team.
- Good planning, organization, and problem-solving skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Works efficiently and effectively in a matrix environment.
- Valid Driver's License.
Preferred Qualifications Include:
- One (1) or more year's additional experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- 6 months on site monitoring experience.
- Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
- Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
- Attention to detail.
- Methodical approach to work.
- Understanding of medical and clinical research terminology and clinical research processes.
- An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
- Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements.
- Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications.
- Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
- Experience using a clinical trial management system (CTMS).
- For medical device positions, experience in providing customer service to device end users.
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