clinical trial specialist

Caris Life Sciences

<div>
 
 At Caris, we understand that cancer is an ugly word&mdash;a word no one wants to hear, but one that connects us all. That&rsquo;s why we&rsquo;re not just transforming cancer care&mdash;we&rsquo;re changing lives.
 
 
 
 We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day:
 
 &ldquo;What would I do if this patient were my mom?&rdquo;
 
 That question drives everything we do.
 
 
 But our mission doesn&rsquo;t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare&mdash;driven by innovation, compassion, and purpose.
 
 
 
 Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
 
 
 
 
 Position Summary
 
 
 
 A Clinical Trial Specialist provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principals. Responsibilities will include, but not limited to, study documentation maintenance, IRB submissions, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, accessioning, and inventory.
 
 
 
 Job Responsibilities
 
 
 
 <ul>
 <li>
 Successfully execute site onboarding process in an effective and timely manner
 </li>
 <li>
 Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support.
 </li>
 <li>
 Monitor and facilitate local site IRB and central IRB activities, including additional site submissions, amendments/changes in research submissions, create/facilitate submission of annual continuing review reports, monitor and notify of document expiration dates, and process fees through accounts payable.
 </li>
 <li>
 Oversees creation of new study and site Trial Master File (TMF) entries, including site information and required documents.
 </li>
 <li>
 Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol.
 </li>
 <li>
 Maintains operational study documents; SOPs, Working Instructions, Lab Manuals, User Guides, and study specific forms that include tracking, preventative maintenance, instrument logs, quality assessments, reports and audits.
 </li>
 <li>
 Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group.
 </li>
 <li>
 Responsible for ensuring sample integrity and maintaining Good Clinical Practice (GCP) compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions. This includes, but not limited to, collecting requisite information, performing data entry for sample tracking/reporting, sample inventory, sample distribution and communicating status with key stakeholders (internal/external).
 </li>
 <li>
 Oversees the shipment tracking, receipt, storage/inventory, maintenance and transfer/distribution of non-clinical samples and clinical study biospecimens.
 </li>
 <li>
 Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under direction of manager.
 </li>
 <li>
 Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment.
 </li>
 <li>
 Enters specimen information into Sample Management System.
 </li>
 <li>
 Reviews associated specimen submission documentation and verified accuracy of data entry.
 </li>
 <li>
 Coordinates and assists in deidentification of specimen requests for purposes of research.
 
 
 </li>
 </ul>
 
 Required Qualifications
 
 
 
 <ul>
 <li>
 Associate or higher degree with biological science coursework required.
 </li>
 <li>
 Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook.
 </li>
 <li>
 Candidates should have 1-2 years' experience in a Biorepository setting or Clinical Trial setting.
 </li>
 <li>
 Experience in handling human biological materials
 </li>
 <li>
 Demonstrates the ability to effectively and respectfully communicate with coworkers, staff, sponsors, and clients.
 </li>
 <li>
 Continuously provides excellent customer service in an efficient and effective manner.
 </li>
 <li>
 Excellent organization and time management/prioritization skills with the ability to both independently and with specific direction on a diverse and demanding workload
 </li>
 <li>
 Attention to detail and problem-solving skills.
 </li>
 <li>
 Ability to multi-task and work in a fast-paced, deadline driven environment.
 </li>
 <li>
 Results oriented, hyper focused on service, quality, and continuous improvement.
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Candidates should have previous experience in a Biorepository setting or Clinical Trial setting.
 </li>
 <li>
 Candidates should have experience with clinical trial regulatory documentation or TMF.
 </li>
 <li>
 Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment.
 </li>
 <li>
 Laboratory Information Management System or Sample Management System experience preferred.
 </li>
 <li>
 Customer service experience is preferred.
 </li>
 <li>
 Good Clinical Practice training, IATA training, and Human Subject Protection training preferred.
 
 
 </li>
 </ul>
 
 Physical Demands
 
 
 
 <ul>
 <li>
 Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time.
 </li>
 <li>
 Ability to lift up to 30 lbs.
 
 
 </li>
 </ul>
 
 Training
 
 
 
 <ul>
 <li>
 Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training.
 </li>
 <li>
 All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
 
 
 </li>
 </ul>
 
 Other
 
 
 
 <ul>
 <li>
 This position requires some evenings, weekends and/or holidays.
 
 
 </li>
 </ul>
 
 Conditions of Employment:
 
 Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
 
 
 This job description reflects management&rsquo;s assignment of essential functions. Nothing in this job description restricts management&rsquo;s right to assign or reassign duties and responsibilities to this job at any time.
 
 
 Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
</div>

Clinical Trial Specialist

ICON Strategic Solutions

<div>
 
 At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON&rsquo;s global expertise. As the world&rsquo;s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
 
 
 
 
 
 
 What you will be doing
 
 
 <ul>
 <li>
 Organizes and delivers analyzable reports and metrics to the clinical study lead
 </li>
 <li>
 Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
 </li>
 <li>
 Collates data for assessments such as feasibility and site selection and reviews site usability database
 </li>
 <li>
 Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
 </li>
 <li>
 Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
 </li>
 <li>
 Collates materials for training and investigator meetings
 </li>
 <li>
 Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
 </li>
 <li>
 Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
 </li>
 <li>
 Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
 </li>
 <li>
 Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
 </li>
 <li>
 Manages and maintains team SharePoint and/or shared drive sites, as needed
 </li>
 <li>
 Communication with sites as directed and maintains site contact information
 </li>
 <li>
 Contributes to line listings review for Blind Data Review Meeting (BDRM)
 </li>
 <li>
 May manage or contribute to oversight of Third Party Vendors (TPV)
 </li>
 <li>
 Tracks and monitors close out activities &ndash; study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
 </li>
 <li>
 Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
 </li>
 <li>
 Proactively recommends process improvement initiatives for the department
 </li>
 </ul>
 
 
 
 
 
 Your profile
 
 
 
 
 
 <ul>
 <li>
 Must have a Bachelor's Degree
 </li>
 <li>
 Must have a minimum of 2 years industry related work experience
 </li>
 <li>
 Experience supporting global trials (NA, LAM, EU, APAC, India)
 </li>
 <li>
 Experience working in TMF, CTMS, SharePoint,
 </li>
 <li>
 Excels in written and verbal communications
 </li>
 <li>
 Self-starter, can work independently with minimal oversight, solution-oriented
 </li>
 <li>
 ICF review experience
 </li>
 <li>
 General competency: PowerPoint/excel skills, meeting minutes
 </li>
 <li>
 Vendor management/oversight experience a plus
 </li>
 <li>
 Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA
 </li>
 </ul>
 
 
 
 
 Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
 
 
 
 
 
 
 Rewards &amp; Benefits
 
 
 
 ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
 
 
 Benefits may include:
 
 <ul>
 <li>
 Competitive base salary and performance related incentives
 </li>
 <li>
 Health and wellbeing programs including medical, dental, and vision coverage where applicable
 </li>
 <li>
 Retirement and pension plans
 </li>
 <li>
 Life assurance and disability coverage
 </li>
 <li>
 Employee assistance programmes and wellbeing resources
 </li>
 <li>
 Learning and development opportunities through structured training and career pathways
 </li>
 </ul>
 
 
 
 
 Benefits may vary depending on role and location.
 
 
 
 
 
 
 Inclusion and Accessibility
 
 
 
 ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
 
 
 
 
 
 If you require reasonable accommodations during the recruitment process, please let us know or submit a request
 
 here
 
 .
 
 
 
 
 
 Are you a current ICON Employee? Please click
 
 here
 
 to apply.
 
</div>

Kelly

<div>
 
 Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. The National Institutes of Health is seeking a
 
 Clinical Trials Specialist
 
 This is a long-term, full-time, contract position based in Bethesda, MD. This position offers a competitive benefits package.
 
 
 
 
 
 
 This is a long-term contract position which offers:
 
 
 
 - Competitive compensation and comprehensive benefit package
 
 
 - Optional health, vision, and dental plans
 
 
 - Paid leave, paid federal holidays, and 401K plan.
 
 
 - Access to NIH&rsquo;s unparalleled resources and niche scientific initiatives
 
 
 
 
 
 
 PRIMARY RESPONSIBILITIES:
 
 
 <ul>
 <li>
 Provide administrative and management support of experimental studies with human subjects and the appropriate conduct of behavioral interventions on individuals, communities, and populations for applications identified by NIH staff as being considered for award
 </li>
 <li>
 Support pre and post-award policy compliance for clinical trials.
 </li>
 <li>
 Conduct risk assessments and determines appropriate levels of oversight for clinical trial applications.
 </li>
 <li>
 Prepare and provide lists of applications approved for award that are classified as Clinical Trials (CTs)
 </li>
 <li>
 Generate lists of CT applications that require risk assessment.
 </li>
 <li>
 Compile lists of CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB).
 </li>
 <li>
 Complete and maintain checklists used for reviewing DSMBs.
 </li>
 <li>
 Track receipt of signed DSMB Conflict of Interest and Confidentiality statements, as well as required DSMB materials.
 </li>
 <li>
 Monitor and document the status of compliance across all stages of each application.
 </li>
 </ul>
 
 
 
 
 
 REQUIREMENTS:
 
 
 <ul>
 <li>
 Bachelors Degree, in Psychology or related discipline is required
 </li>
 <li>
 Minimum 5 years of clinical research experience
 </li>
 </ul>
 
 
</div>

Clinical Trial Specialist - NIH

Regeneron

<div>
 Clinical Study Specialist- R46129
 
 
 
 Position Description
 
 
 
 The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
 
 
 
 Roles Responsibilities
 
 
 
 <ul>
 <li>
 Organizes and delivers analyzable reports and metrics to the clinical study lead
 </li>
 <li>
 Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
 </li>
 <li>
 Collates data for assessments such as feasibility and site selection and reviews site usability database
 </li>
 <li>
 Contributes to review of study documents such as informed consent forms, case report forms
 </li>
 <li>
 Facilitates study document reviews per company standard operating procedures
 </li>
 <li>
 Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
 </li>
 <li>
 Collates materials for training and investigator meetings
 </li>
 <li>
 Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
 </li>
 <li>
 Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
 </li>
 <li>
 Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
 </li>
 <li>
 Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form)
 </li>
 <li>
 Manages and maintains team SharePoint and/or shared drive sites, as needed
 </li>
 <li>
 Communication with sites as directed and maintains site contact information
 </li>
 <li>
 Contributes to line listings review for Blind Data Review Meeting (BDRM)
 </li>
 <li>
 May manage or contribute to oversight of Third-Party Vendors (TPV)
 </li>
 <li>
 Tracks and monitors close out activities ? study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
 </li>
 <li>
 Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
 </li>
 <li>
 Proactively recommends process improvement initiatives for the department
 
 
 </li>
 </ul>
 
 Skills
 
 
 
 <ul>
 <li>
 Attention to details for the ability to track information and deliver on assigned study activities
 </li>
 <li>
 Good communication and interpersonal skills; ability to build relationships internally and externally
 </li>
 <li>
 Ability to be resourceful and to demonstrate problem solving skills
 </li>
 <li>
 Demonstrate the ability to proactively assess information and investigate impact on clinical trials
 </li>
 <li>
 Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
 </li>
 <li>
 Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
 </li>
 <li>
 Basic familiarity with medical terms and clinical drug development
 </li>
 <li>
 Awareness of ICH/GCP
 
 
 </li>
 </ul>
 
 Education &amp; Experience
 
 
 
 <ul>
 <li>
 Minimum of a Bachelor's degree
 </li>
 <li>
 2 years? industry related work experience in a clinical setting
 </li>
 </ul>
</div>

Temp - Clinical Study Specialist

Fortvita Biologics

<div>
 
 Fortvita is seeking a dynamic and experienced
 
 Study Start-Up Specialist (SSU)
 
 who will be responsible for managing and coordinating all site start-up activities for oncology clinical trials, ensuring timely initiation and regulatory compliance. This role serves as the primary point of contact for assigned sites during the start-up phase, working closely with investigators, regulatory agencies, ethics committees, and internal teams to facilitate efficient trial activation.
 
 
 
 
 
 
 
 Responsibilities
 
 
 
 
 <ul>
 <li>
 
 Site Identification and Selection:
 
 Identify and select appropriate investigational sites for oncology clinical trials, coordinating feasibility assessments and site evaluation visits.
 </li>
 <li>
 
 Regulatory and Ethics Submissions:
 
 Prepare, review, and submit essential regulatory documents, including study protocols, informed consent forms (ICFs), and ethics committee applications.
 </li>
 <li>
 
 Document Collection and Review:
 
 Collect, review, and approve essential site documents required for site activation and regulatory approval. Ensure all documents are uploaded to the electronic Trial Master File (eTMF) in a timely manner.
 </li>
 <li>
 
 Site Activation:
 
 Coordinate site initiation activities, including scheduling initiation visits, ensuring site personnel are trained, and providing necessary resources for study start.
 </li>
 <li>
 
 Stakeholder Coordination:
 
 Serve as the primary point of contact for assigned sites, resolving queries and facilitating communication between investigators, regulatory bodies, and internal teams.
 </li>
 <li>
 
 Timeline Management:
 
 Forecast, track, and report on site activation metrics and timelines, ensuring all sites are activated according to study schedules.
 </li>
 <li>
 
 Compliance and Quality Assurance:
 
 Ensure all start-up activities comply with ICH/GCP guidelines, local regulations, and sponsor SOPs. Maintain high standards of documentation and record-keeping.
 </li>
 <li>
 
 Contract and Budget Management:
 
 Assist with contract and budget negotiations with study sites.
 </li>
 <li>
 
 Training and Support:
 
 Provide training and support to site staff as needed.
 </li>
 <li>
 
 Issue Escalation:
 
 Identify and escalate site issues or delays to management for timely resolution.
 </li>
 </ul>
 
 
 
 
 Qualifications
 
 
 
 
 
 Required
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in life sciences, nursing, pharmacy, or a related field.
 </li>
 <li>
 Minimum of 3 years of clinical research experience, with a strong preference for experience in oncology trials and site start-up activities.
 </li>
 <li>
 Thorough understanding of clinical trial regulations (ICH/GCP), regulatory submission processes, and essential document requirements.
 </li>
 </ul>
 
 
 
 Preferred
 
 
 
 <ul>
 <li>
 Exceptional organizational and time management skills.
 </li>
 <li>
 Strong communication and interpersonal abilities.
 </li>
 <li>
 Attention to detail and problem-solving aptitude.
 </li>
 <li>
 Ability to multitask and work independently or as part of a team.
 </li>
 <li>
 Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint).
 </li>
 <li>
 Experience with oncology clinical trials and familiarity with electronic clinical trial management systems.
 </li>
 </ul>
 
 
 
 Compensation and Benefits Include:
 
 
 
 <ul>
 <li>
 Competitive base salary, bonus, and equity for all employees.
 </li>
 <li>
 Actual compensation may vary depending on factors such as location, skills, experience, and performance.
 </li>
 <li>
 401(k) retirement plan with employer matching contributions.
 </li>
 <li>
 Comprehensive medical, dental, and vision insurance.
 </li>
 <li>
 Generous paid time off policy, including company holidays and floating holidays.
 </li>
 </ul>
 
 
 
 Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.
 
 
 
 
 We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.
 
 
 
 
 
 Additional Legal Disclaimers
 
 
 
 
 
 Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.
 
 
 
 
 Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.
 
 
 
 
 Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita&rsquo;s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.
 
</div>

Study Start-Up Specialist

University Of Washington

<div>Job Description
The Division of Hematology and Oncology has an outstanding opportunity for a Clinical Trials Budget Specialist to join their team in a limited-term appointment.
About this Opportunity:
Reporting to the Clinical Research Budget Manager, this position works closely with research faculty and staff and is responsible for clinical research budgeting and revenue cycle strategy, development and oversight. Specifically, this position oversees and negotiates optimal pricing and payment terms for investigator initiated and industry sponsored clinical trials, ensuring regulatory compliance and fiscal accountability.
KEY RESPONSIBILITIES
Clinical Trial Budget Development, Revenue Cycle, and Financial Risk Management :
<ul><li>Perform comprehensive and independent review of all documents related to the research study funding, including study budget, protocol, consent form, contract, and other supporting documentation.
</li><li>In collaboration with Principal Investigators, identify and differentiate between research-specific procedures and standard of care.
</li><li>Using established systems and committees, seek appropriate prices quotes from University of Washington, Fred Hutch Cancer Center, and other partner institution service departments. Independently negotiate successful clinical trial budgets and payment terms with study sponsors.
</li><li>Coordinate with disease program research staff to ensure each study&rsquo;s consent form delineates research care and standard of care.
</li><li>Coordinate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, and the FHCC Research Implementation Office.
</li></ul>Post Award Revenue Recovery :
<ul><li>Perform comprehensive and independent review of patient activity, and in comparison to the Clinical Trial Agreement, perform complex financial reconciliations to ensure full revenue recovery.
</li><li>Identify invoiceable items in contracts and ensure regular invoicing and accounts receivable aging follow up.
</li><li>Use CTMS system, ONCORE, for financial reconciliation of studies that are operational in that system. Independently troubleshoot payment issues with sponsors in a timely manner.
</li><li>Identify and assist faculty to mitigate budget deficits, including communication with sponsor for amendments.
</li></ul>Required Qualifications:
To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
MINIMUM REQUIREMENTS
Bachelor's Degree in Business, Science, or Health-related field and a minimum of three years&rsquo; experience with clinical research budget development, clinical research coordination, or related research or healthcare experience.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED REQUIREMENTS
<ul><li>Ability to work effectively and efficiently in a group environment
</li><li>Exceptional organizational and customer service skills
</li><li>Strong written and oral presentation skills
</li><li>Ability to communicate effectively with all levels of faculty, management and clinical research staff
</li><li>Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
</li><li>Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely
</li><li>Ability to prioritize and organize work independently
</li><li>Demonstrated skill in using Microsoft Excel
</li><li>Experience in an academic medical center
</li><li>Experience negotiating clinical trial budget and payment terms
</li><li>Experience as a research study coordinator
</li><li>Experience in oncology clinical research
</li><li>Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols.
</li><li>Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
</li><li>Experience with using International Classification of Diseases, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment
</li><li>Strong working knowledge Microsoft Office Suite
</li><li>Experience using Epic for Research charge routing is highly desirable
</li><li>Experience using OnCore is highly desirable
</li></ul>WORKING CONDITIONS
<ul><li>Fast-paced office environment, with a high volume of often-complex projects.
</li><li>The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day.
</li><li>Work week regularly exceeds 40 hours per week.
</li><li>The position is a 100% remote position and requires working during the regular business hours of the institution.
</li><li>This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
</li></ul>Compensation, Benefits and Position Details
Pay Range Minimum:
$80,004.00 annual
Pay Range Maximum:
$104,568.00 annual
Other Compensation:
<ul><li></li></ul>Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-temporary-per-diem-and-less-than-half-time/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a temporary position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
Not Applicable
About the UW
Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.
Our Commitment
The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81 .
To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law .</div>

Clinical Trials Budget Specialist (Temporary)

ICON plc

<div>Clinical Research Associate
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. 
 
Key responsibilities include:<ul><li>
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.</li><li>
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.</li><li>
Collaborating with investigators and site staff to facilitate smooth study conduct.</li><li>
Performing data review and resolution of queries to maintain high-quality clinical data.</li><li>
Contributing to the preparation and review of study documentation, including protocols and clinical study reports</li></ul>
Your Profile:
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a scientific or healthcare-related field.</li><li>
Minimum of 2 years of experience as a Clinical Research Associate.</li><li>
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.</li><li>
Strong organizational and communication skills, with attention to detail.</li><li>
Ability to work independently and collaboratively in a fast-paced environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div>

Clinical Research Associate II

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