Fortrea_富啓睿台灣股份有限公司

This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. Our Flexible Solutions Clinical Research Associates are based at our pharmaceutical client sites and manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include: •Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation •Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned •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 •Site management as prescribed in the project plans •Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs •Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management •May support in organization of meetings and other tasks as instructed by supervisor. Requirements: •B.A./B.S. (Life Science preferred) or equivalent healthcare experience. -CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered. -SCRA: candidates with 4 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered. •Global clinical trial experience is needed. •Oncology study experience is needed. •Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements. •Basic understanding of the clinical trial process. •Fluent in local language and English. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. Job Overview: Site monitoring and site management responsibility for 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: 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 in a related allied health profession from an appropriately accredited institution. 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): 2 years CRA experience with on-site monitoring experience. Oncology trial experience is MUST. 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.