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.

• As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

  We are currently seeking a Assc Project Coordinator, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

  This is a full-time, remote based position in based in US.

  If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

  Many Technicians are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.

  WHAT YOU WILL DO

  You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

  Other key responsibilities:

  (include but not limited to)

• Responsible for the coordination and completion of project tasks in suppot of Project Management for low complex studies.

• Initiates creation of study specific documents (e.g., Project Management Plan, Communication Plan, Risk Mitigation Plan).

• Works with the document specialist team as appropriate to transfer documents in a timely manner to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements.

• Works with a more senior PC or PM in developing study specific documents (e.g., Project Management Plan, Communication Plan, Investigator Package Plan, Risk Register, Project Specific Training Matrix and any other applicable plans as required), including compliance with client-specific requirements for low complex studies; distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents.

• Works with a more senior PC or PM to monitor training compliance of the study team and update the training matrix as required.

• Maintains an internal standardized filing structure for study-related documents; proactively maintains documents within the filing structure.

• Responsible for project setup activities (e.g., study ID request, SAS Environment Setup request, eTMF, Study-specific Distribution Lists, etc.).

• Assists the PM or a more senior PC in the setup of and updating of CTMS, as required.

• Attends and assists in the organization of study-related meetings, as required; distributes meeting agendas; maintains and distributes meeting minutes, Project Log, Risk Register, and study team contact lists; participates in client visits as needed.

• If required may assist document specialists in document transfer to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements; works with the PM and Document Specialist (DS) to lead eTMF audit readiness efforts and to set up any applicable eTMF QC tools, and may assist in the coordination of eTMF quality reviews.

• Assists in the development of project tools as required for the project (e.g., screening and enrolment log and development of investigator training).

• Assists the PM or a more senior PC in the formatting, posting, compiling and entering budgeted hours into the project timeline.

• Performs other duties, as assigned.

The hourly rate for this position is USD $25 to $28 per hour

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), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.  For more detailed information, please click here. 

Application Deadline: September 26, 2024

#LI-Remote

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

401(K)

Paid time off (PTO)

Employee recognition awards

Multiple ERG’s (employee resource groups)

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.

YOU NEED TO BRING…

University/college degree, preferably in a healthcare/scientific field. 

Specific clinical research experience may be substituted for education.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Knowledge of the clinical trial process with early clinical pharmacology experience preferred.

Minimum 1-2 years of experience in a research environment.

Knowledge of protocol designs, study objectives, study procedures, and project-related timelines.

Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines.

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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