Startup Associate I

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.
- With support from a more experienced start up team member, ensures documents are filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time.
- With support from a more experienced start up team member, develops collecting and tracking regulatory and investigator documents required for effective and compliant study site activation and maintenance.
- With support from a more experienced start up team member, ensures that all assigned maintenance and start up activities are on track and support study deliverables.
- Follow up with sites in order to ensure documents required are collected in a timely manner.
- Escalate study issues appropriately and in a timely fashion.
- Update study documents when there are changes in study personnel/study amendments.
- With support from a more experienced start up team member, may contribute to the preparation of submissions to IRB/EC with appropriate supervision.
- With support from a more experienced start up team member, may review and negotiate site contracts, confidentiality non-disclosure agreements, and other related documents in accordance with defined processes and timeframes under supervision.
- With support from a more experienced start up team member, may liaise with Fortrea Contract Specialist and other team members as appropriate to finalize site contract language.
- May liaise with Investigator Grant team, Clinical Operations team, and sites to develop, modify, and monitor site budgets and payment terms.
- May obtain signatures on site contracts in accordance with defined process and timelines.
- With support from a more experienced start up team member, may track the progress of contract and budget milestones, intervening and escalating as appropriate.
- With support from a more experienced start up team member, may manage changes to site contracts for amendments and work scope change.
- With support from a more experienced start up team member, may review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
- With support from a more experienced start up team member, may review amended Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- With support from a more experienced start up team member, may review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
- Ensures high quality site specific and site activation documents are filed in the TMF in a timely manner according to study plans.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
- Perform other duties as assigned by management.
- This role will be primarily focused on Document Reviewer tasks (greenlight package reviews, etc) to help strengthen the group's focus on quality and efficiency.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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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