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.
Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study.
Essential Job Duties:

• Primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded.
• Independently undertakes routine studies and more complex studies with guidance. May coach and mentor Operations coordinators and junior staff.
• Study Set-up - Performs all aspects of the set up process to include the
• development and approval of study specific documents, study schedules and
• clinical procedure planning
• Coordination - Coordinates the running of critical events, i.e. check in, PK
• days, check out by resolving/escalating issues identified by both staff and study
• participants. Monitors and maintains participant safety, dignity and compliance,
• including coordination of appropriate medical consultation/treatment as
• appropriate. Provides updates regarding study participants wellbeing to the
• investigators and Project Manager including adverse event updates
• Study Meetings -Facilitates/attends and contributes to all key Study
• Planning meetings, i.e. Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting
• Protocol Review - Reviews protocols, provides consolidated comments
• from the clinical site on the draft study protocol to the Project Manager or Medical Writer, considering the logistics, safety (staff and study participants), and site's capabilities. May distributes final protocols and amendments to the site

• Study Planning - Proactively works with the site to ensure that the laboratory equipment and all operational requirements are fulfilled and that the study is adequately resourced
• Working closely with the Operations and Pharmacy to ensure dosing runs efficiently and that all documentation is completed accurately within a timely manner
• Complaints - handles participant complaints efficiently and effectively to maintain customer satisfaction.
• Clients - Is aware of client expectations for trial conduct and works to meet or exceed them. Facilitates client visits and attends client calls with the assistance of the Project Manager and/or site management where appropriate. Participates in Client and process Audits by covering study conduct questions.
• Training - Deliver/facilitate study specific training
• Learns and develops Clinical skills to perform study tasks and performs procedures as necessary

• Participant eligibility - verifies eligibility for Panel Selection and at Pre dose by determining whether protocol criterion has been met. Communicates with investigators and PM regarding study participant eligibility
• Oversees maintenance of study master file ensuring that site related documents are available for uploading to the eTMF
• Create/manage study specific shipping calendar ensuring biological samples are shipped as directed by the client in a timely manner
• Data Monitoring - Facilitate/coordinate monitoring visits and coordinate site resolution of any comments/queries raised
• Quality - Ensures all protocol deviations and or unscheduled events are properly documented and communicated.
• Works with site management to maintain timely completion of issues raised from CQI's and client audits, implementing new processes where necessary
• Works with Recruitment/Screening to define a recruiting plan ensuring that the study is recruited on schedule, updating Project Manager on a regular basis
• Consult with pharmacy staff to ensure awareness of receipt inventory, accountability and disposal of clinical trial materials
• Assist with on time source document completion and query process
• Authorizes study participant stipend payments as required
• Performs other related duties as assigned

Education / Experience

• University /college degree desirable (life sciences, or related subject field preferred) or certification in a related allied health profession
• In lieu of a degree, typically 3 years' experience in a related field will be considered
• Typically, a minimum 3-4 years' experience in a research environment
• Knowledge of protocol designs, study objectives and study procedures
• Knowledge of drug development process, ICH guidelines and GCP
• Previous customer service experience desirable
• Previous experience of coordinating people or processes desirable.
• University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology).

Benefits:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple ERG's (employee resource groups)

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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