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.

We are seeking a Study Start-up Specialist who will support the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.. The position will also support site and study teams to achieve rapid site start-up.

Responsibilities:

Work directly with assigned sites on all site related essential document collection and review.
Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
Ensure standards are applied to the SSU processes across projects.
Review site essential documents for start-up including but not limited to: ICF, FDF, 1572, CVs etc
Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
Review and provide feedback to management on site performance metrics.
Ensure accuracy and completeness of the eTMF for assigned sites during start up

Requirements:

Education

Bachelor’s Degree or international equivalent required; Life Sciences preferred.

Experience

2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
Ability to explain data to facilitate decision making processes to be data driven.
Knowledge and understanding of clinical study protocols and essential documents
Strong organizational skills, decision making, communication and negotiation skills.
Effective communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Strong proficiency with Microsoft Office applications
Fluent business English (oral and written)

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO).

- Remote

Application deadline is September 6th, 2024.

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.

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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SSU Specialist