Jobs · OTHR

Start-up Specialist, Phase I

Fortrea · United States · 1 mo ago
RemoteRemoteOTHRFull-time
We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes: Job Overview (maybe About the role), Summary Of Responsibilities, Qualifications (Minimum Required), Experience (Minimum Required) maybe part of Requirements, Work Environment, Physical Requirements, etc. No explicit Benefits, Pay, Schedule. So we should not create those sections. We need to preserve all substantive info, no boilerplate like EEO, scam warning, application instructions, cookie/navigation, etc. Remove lines like "Remote Applications will be accepted on an ongoing basis Learn more about our EEO & Accommodations request here." Also remove "Our CPS team is currently seeking a Study Start Up Specialist with 2+ years of start-up experience residing with the U.S." maybe that's part of overview. We need to format with

headings and
  • for lists,

    for prose. We need to decide sections: About the role (Job Overview), Responsibilities (Summary Of Responsibilities), Requirements (maybe combine Qualifications and Experience), Skills (maybe not explicit), but we could include Skills if present: they mention "Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites. Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them." That's more like qualifications/skills. Could put under Requirements or Skills. Since we have Qualifications and Experience sections already, we could have Qualifications (education) and Experience (work experience). Skills could be separate if we want, but we need to avoid thin sections. Perhaps combine Qualifications and Experience into a single Requirements section? But the instruction says use headings for those categories if content exists. We have content for Qualifications (education) and Experience (minimum required). So we can have two sections: Qualifications and Experience. That's okay. We also have Work Environment and Physical Requirements; those could be under a section like Working Conditions? Not in list. Could maybe put under Responsibilities? Not appropriate. Could create a section "Work Environment" but not in allowed headings list. The allowed headings are only those listed: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we must fit content into those headings. We can put Work Environment and Physical Requirements under Requirements or Qualifications? Probably under Requirements (since they are job requirements). Or we could create a "Requirements" section that includes both qualifications and experience and work environment/physical. Thus we will have:

    About the role

    with paragraph summarizing job overview.

    Responsibilities

    with
    • list of responsibilities.

      Requirements

      with
      • list including education, experience, skills, work environment, physical requirements. We should not repeat job title as heading. We must preserve all substantive info: need to include details like "Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor." etc. We need to extract responsibilities list from the "Summary Of Responsibilities" paragraph which is a long sentence with many items separated by periods. We'll break into bullet points. Similarly for qualifications: list education, experience, etc. We need to avoid boilerplate: remove lines about EEO, accommodation request, remote applications, etc. Let's parse the posting: Original text: "Our CPS team is currently seeking a Study Start Up Specialist with 2+ years of start-up experience residing with the U.S. Job Overview Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable. Summary Of Responsibilities Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).Perform a review of final submission documents as applicable.Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standardsPrevent and escalate study issues appropriately and in a timely fashion.Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable].Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.Participate in team and project meetings as applicable.When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.Performs all other duties as needed or assigned. Qualifications (Minimum Required) University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered. Experience (Minimum Required) Minimum of 2 years of experience in clinical development or start-up/ regulatory process.Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them. The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.Changing priorities constantly asking you to prioritize and adapt on the spot.Teamwork and people skills are essential for the study to run smoothly.Technology based. We collect our data directly into an electronic environment. Work Environment Work is performed in an office environment with exposure to electrical office equipment.Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements Ability to sit for extended periods and operate a vehicle safely.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.Regular and consistent attendance.Varied hours may be required. - Remote Applications will be accepted on an ongoing basis Learn more about our EEO & Accommodations request here." We need to strip the trailing "- Remote Applications will be accepted on an ongoing basis Learn more about our EEO & Accommodations request here." Now produce HTML. We'll create:

        About the role

        Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.

        Then Responsibilities: we need to break the long sentence into bullet points. Let's list responsibilities from "Summary Of Responsibilities" text: - Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries. - Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable. - Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval. - Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable). - Perform a review of final submission documents as applicable. - Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards. - Prevent and escalate study issues appropriately and in a timely fashion. - Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]. - Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. - Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision. - Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time. - Participate in team and project meetings as applicable. - When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams. - Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. - Proactively resolve informed consent issues and other potential difficulties with study sites. - May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate. - Proactively identifying and escalating to Submission Leads any risk to meeting deliverables. - Notify the Submissions Lead of hours identified as Out-of-S

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