Summary of Responsibilities: Follow all applicable departmental Standard Operating Procedures and Work Instructions.Complete day-to-day tasks ensuring quality and productivity.Track and report metrics as determined by ma…
Skills: Clinical systems management, CTMS, EDC, IWRS, TMF management
Summary of Responsibilities: Follow all applicable departmental Standard Operating Procedures and Work Instructions. Complete day-to-day tasks ensuring quality and productivity. Track and report metrics as determined by …
Skills: Clinical Systems Management, Trial Master File Management, CTMS, IWRS, EDC
Job Overview: The CRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operatio…
Job Overview: The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CTA shall ref…
Summary of Responsibilities: Serve as the marketing lead for assigned priority service, solutions and/or therapeutic areas.Design and execute integrated marketing strategies and programs to grow assigned business or ther…
Job Overview: Prepares and negotiates and assists in the execution and retention of site agreements, confidentiality agreements, letters of indemnification and other contracts for Sponsors who contract Fortrea to perform…
Skills: Contract negotiation, Contract administration, SOP compliance, Clinical study support, Stakeholder communication
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. T…
Skills: Clinical monitoring, Site management, Regulatory compliance, Data integrity, Case report forms
This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interv…
Skills: Clinical trials, Study start-up, Regulatory compliance, Project management, Team leadership
Summary of Responsibilities: Owns all aspects of the appropriate proposal process (text, quote, budget, and/or response to Requests for Information [RFIs]) for assigned opportunities (inclusive of managing opportunities …
Skills: Proposal management, Budget development, Text development, Project management, Customer service
Job Overview: Responsible for handling all public inquiries pertaining to study participation. Schedules screening appointments for qualified participants. Summary of Responsibilities: Receiving and placing calls from an…
Skills: Customer service, Call center operations, Data entry, Medical terminology, Communication skills
Administrative Assistant, Early Phase Clinical Research – Dallas, TX
Dallas, Texas, United States · On-site
Mid level
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 an Administrative Assistant/Front Desk, to greet, receive, a…
Skills: Administrative Support, Receptionist Duties, Customer Service, Multi-tasking, Problem Solving
Fortrea is one of the world´s largest and longest-established early-phase clinical research organizations. From first-in-human to exploratory biomarker or complex ph1b programs, our Clinical Pharmacology team generate cr…
The RCM Billing Manager will be responsible for all processes and resources related to billing procedures, including project / contract setup, invoicing, processing rebates, and processing credits and rebills, but not li…
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/I…
Skills: Clinical research, Regulatory affairs, Site start-up, ICH guidelines, GCP compliance
Clinical Research Physician - MD for Phase I Site, Madison WI
Madison, Wisconsin, United States · On-site
Mid level
Clinical Research Physician, Madison, WI Phase I Onsite Fortrea is hiring a dynamic Clinical Research Physician at our Madison, WI Phase I site — onsite, full-time, and fully immersed in cutting-edge clinical trials. If …
Skills: Clinical Research, Medical Monitoring, Data Review, Protocol Adherence, Regulatory Compliance
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project …
Skills: Clinical monitoring, Site management, Regulatory compliance, GCP, Data integrity
Job Overview: Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics t…
Skills: SAS Programming, Medidata Rave, Oracle Inform, Spotfire, Tableau
Sr Clinical Research Associate I Sydney, Melbourne, or Perth
Sydney, New South Wales, Australia · Hybrid
Mid level
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. T…
Skills: Clinical monitoring, Site management, Regulatory compliance, Serious adverse event reporting, Case report form review
Research Tech I (On-Call) (Daytona Beach, FL/on-site)
Daytona Beach, Florida, United States · On-site
Entry level
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 …
Senior Clinical Project Manager or Project Manager II - Cardiology, Respiratory, Diabetes/Weight loss, Immunology or MASH
Durham, California, United States · Remote OK
$125k–$160k/yr
Senior
Our FSO team is seeking a Cardiology, Respiratory, Diabetes/Weight loss, Immunology or MASH Sr. Clinical Project Manager or Project Manager II to join our growing team. This role requires 3-5+ years of global project man…
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Full-time
Posted 8h ago
Apply by Aug 8
~40 hrs/week
Responsibilities
The Senior Centralized Study Coordinator manages clinical systems, study documentation, and databases while ensuring compliance with departmental procedures. They also facilitate team communication, oversee vendor activities, and track study milestones to ensure project health and effective site management.
Requirements
The role requires proficiency in clinical trial management systems and documentation standards such as TMF and EDC. Candidates must demonstrate strong organizational skills, the ability to manage study timelines, and experience in coordinating cross-functional study team activities.
Full job description
Summary of Responsibilities:
Follow all applicable departmental Standard Operating Procedures and Work Instructions.
Complete day-to-day tasks ensuring quality and productivity.
Track and report metrics as determined by management according to required timelines.
Participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
Other duties/activities as assigned by study management team, but not limited to:
Manage clinical systems & access management
Manage study documents such as study level, country level and site level
Maintain study databases (CTMS, IWRS, EDC etc.)
Support study team in e-TMF management activities
Support study team in data review and support activities.
Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
Address all outstanding issues for sites and provide a snapshot of issues to Clinical team including CRA’s to make the site visits more effective and efficient.
Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
Actively support compliance metrics including TMF, CTMS, and overall project health.
Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client.
Work with Study Team to maintain WISER moments.
May assist with additional cross-functional tasks according to project needs.
Initiates RIM changes, manages PCC Log, and supports documentation and impact tracking.
Assists in vendor management activities including invoice tracker and PO requisitions.
Handles PII assessments, system documentation, and updates to XRIM as needed
Additional responsibilities (Centralized study team may perform below activities):
Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements.
Bringing life-changing benefits to patients faster
Industry
Biotechnology Research
Company size
10,001+ employees
Headquarters
Research Triangle Park, NC
LinkedIn followers
260,706
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
clinical researchclinical trialsand medical device trialsHealth CareClinical Trials
Bringing life-changing benefits to patients faster
Industry
Biotechnology Research
Company size
10,001+ employees
Headquarters
Research Triangle Park, NC
LinkedIn followers
260,706
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
clinical researchclinical trialsand medical device trialsHealth CareClinical Trials