clinical trials 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)

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

WVU Medicine

<div><h2 class="jobSectionHeader">Welcome! We&rsquo;re excited you&rsquo;re considering an opportunity with us! To apply to this position and be considered, click the Apply button located above this message and complete the application in full. Below, you&rsquo;ll find other important information about this position.
</h2>Coordinates and manages clinical trials/protocols within the Department ensuring adherence to protocol requirements and regulatory guidelines. Manages the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data.
MINIMUM QUALIFICATIONS :
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1. Associate's degree in nursing AND current Registered Nurse license issued by the state in which services will be provided or current multi-state Registered Nurse license through the enhanced Nurse Licensure Compact ( eNLC )
OR an advanced degree (i.e. MA, MD, PhD) in a scientific, healthcare, or other related field.
 
2. Obtain certification in Basic Life Support within 30 days of hire date.
 
3. Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date into Clinical Research Specialist role.
 
EXPERIENCE:
 
1. Three (3) years clinical experience.
PREFERRED QUALIFICATIONS :
EXPERIENCE:
 
1. Two (2) years research experience.
CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an all-inclusive list of all responsibilities and duties. Other duties may be assigned.
1. Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.
 
2. Develops a mechanism for subject recruitment and ongoing communications with the primary care physician and nursing staff and serves as a liaison between the WVU IRB, PI and Sponsor or Sponsor&rsquo;s representative, as appropriate.
 
3. Prepares Annual Protocol Reviews and Study Summaries for submission to WVU IRB. Prepares and reviews clinical trial budgets. Reviews and submits clinical Trial Agreements (including clinical trial budgets) to the WVU Office of Sponsored Programs.
 
4. Coordinates Protocol Review Committee Meetings, and attends other study related meetings as necessary, to ensure peer review of all protocols under consideration for IRB submission.
 
5. Reviews with the PI the inclusion/exclusion criteria, overall structure, and requirements of each protocol and the protocols summary sheet and informed consent form for accuracy and clarity.
 
6. Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled.
 
7. Clinical coordination of protocols and clinical trials, including scheduling follow up visits and testing, assess subject response and review of laboratory data.
 
8. Provides quality assurance for the clinical protocols and investigations, ensuring protocol guidelines are followed.
 
9. Explores and evaluates opportunities for federal, state, private and institutional funding and external presentations, including grant writing and submission.
 
10. Coordinates care management of research patients undergoing treatment in the suite.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Requires manual dexterity used in operating office equipment.
 
2. Requires standing and bending in the assessment and treatment of patients.
 
3. Prolonged periods of sitting and the ability to walk moderate distances.
 
4. Some manual work may be included.
 
5. Occasional heavy lifting (patient assistance) and the ability to move equipment.
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Normal clinical environment. There is patient contact and potential to come in contact with patients having communicable disease. The presence of blood and specimen care and processing is a routine part of this environment.
SKILLS AND ABILITIES:
1. Excellent written, oral, and interpersonal communication skills. Ability to speak effectively before groups. Ability to write routine reports and correspondence.
 
2. High degree of computer literacy, MS Office products.
 
3. Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical. Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
 
4. Analytical skills include the technical aspects of gathering data for purposes of study-related activities.
 
5. Careful attention to detail.
 
6. Excellent organization skills and ability to prioritize a variety of tasks. Excellent time and project management skills.
 
7. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and provides administrative and regulatory management of protocols and clinical trials ensuring compliance with WVU IRB, GCP guidelines and code of federal regulations.
Additional Job Description:
Scheduled Weekly Hours:
40
Shift:
Exempt/Non-Exempt:
United States of America (Exempt)
Company:
WVUH West Virginia University Hospitals
Cost Center:
118 WVUH HVI Clinic
Address:
1 Medical Center Drive
Morgantown
West Virginia
Equal Opportunity Employer 
West Virginia University Health System and its subsidiaries (collectively &quot;WVUHS&quot;) is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. WVUHS strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. All WVUHS employees, other workers, and representatives are prohibited from engaging in unlawful discrimination. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment.</div>

Clinical Research Specialist

Semmes Murphey Foundation

<div>Description: The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team. 
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.
Essential Duties and Responsibilities:<ul><li>
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures</li><li>
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence</li><li>
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track</li><li>
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies</li><li>
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files</li><li>
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol</li><li>
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager</li></ul>
Requirements:

MINIMUM:<ul><li>
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field</li><li>
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities</li></ul>
PREFERRED:<ul><li>
Five plus years of clinical research regulatory experience</li><li>
Master's degree in related field</li><li>
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)</li><li>
Experience supporting multi-site or industry-sponsored clinical trials</li></ul>
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail. 
Equal Opportunity Employer/Veterans/Disabled
#SMF</div>

Clinical Research Regulatory Specialist

Temple University Health System

<div></div><div><div>The Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Division of Gastroenterology Department is searching for a Clinical Research Specialist to join our team!
Become a part of the Temple family and you will have access to the following: 
Full medical, dental, vision coverage 
Paid time off 
11 Paid Holidays 
Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE 
A generous retirement plan and so much more! 
 
Salary Grade: T24 
Learn more about the &ldquo;T&rdquo; salary structure
Salary Range: Up to $52,000.00 per year 
A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant&rsquo;s education and experience, all relevant internal equity considerations, department budget, and funding source.<div>
Job Details: 
<ul><li>This position is full-time</li><li>This position will be on-site</li><li>This position requires the following background checks: Personally Identifiable Information/Cash Handling</li></ul></div>
Position Summary: 
The Division of Gastroenterology at Temple University Lewis Katz School of Medicine is seeking a highly motivated individual to assist with ongoing research projects in the field of Gastroenterology involving the areas of gastrointestinal motility and gastroparesis.
This person will work closely with the principal investigator (Dr. Henry Parkman) on projects. These studies involve disorders of gastric motility and function such as gastroparesis, functional dyspepsia, and chronic nausea and vomiting. The individual should be energetic, and willing to work with others on a variety of projects.
This position will play an important part in the success of the research studies and must be able to work independently and within a team. In this capacity, this person will work closely with the principal investigator on the primary project which will involve assessing gastrointestinal motility as measured by high resolution electrogastrography (EGG).
Responsibilities include patient recruitment, screening, obtaining informed consent, and enrolling research subjects in clinical studies, coordinating research-related tests, scheduling study visits, performing the high-resolution EGG studies, data collection, data entry and regulatory submissions (IRB).<div>
Required Education and Experience: 
<ul><li>Bachelor&rsquo;s degree in a life science or other health professions field and a minimum of two years of related experience.</li><li>An equivalent combination of education and experience may be considered.</li></ul></div><div>
Essential Functions of Position: 
<ul><li>Perform high resolution electrogastrographic (EGG) recordings on patients and normal subjects.</li><li>Primary contact for research subjects</li><li>Manage data collection, data entry, and processing</li><li>Present project updates at clinical research meetings</li><li>Day to day management of research project activities</li><li>Assist with conducting clinical trials</li><li>Performs other duties as assigned</li></ul></div><div>
Required Skills and Abilities: 
<ul><li>Strong knowledge of computer programs, computer spreadsheets &amp; data analysis.</li><li>Excellent written and oral communications skills</li><li>Able to resolve problems/issues</li><li>Detail oriented</li><li>Knowledge of medical terminology</li><li>Flexible in an ever-changing environment</li><li>Proficient in standard computer programs (word, excel, PowerPoint, etc.)</li><li>Conduct oneself in a professional and courteous manner</li></ul></div><div>
Additional Miscellaneous Information: 
<ul><li>This position requires PII/Cash Handling Clearance prior to the commencement of service</li></ul></div>
Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. 
 
Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. 
 
Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review. 
 
You may request a copy of the report by calling Temple University&rsquo;s Campus Safety Services at 215-204-7900.</div></div>

University of Southern California

<div>Job ID REQ20174848 Category Nursing</div>
 <div>The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the &quot;Trojan Family,&quot; which is comprised of the faculty, students and staff that make the university what it is.
We are looking for a highly motivated and qualified candidate with experience in clinical trials data management. The following are the specific job functions:<ul><li>
Reads and understands clinical data from medical records. Extracts and enters required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).</li></ul><ul><li>
Maintains currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback.</li></ul><ul><li>
Interfaces with sponsors of externally sponsored trials. Provides timely data entry, plans and organizes monitoring visits and responds to inquiries.</li></ul><ul><li>
Performs follow up for study patient survival by reviewing medical records. Contacts other institutions for data on patients hospitalized at other institutions.</li></ul><ul><li>
Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, National Cancer Institute (NCI) sponsored and Cooperative Group studies. Discerns basic data discrepancies/protocol violations. Assists in obtaining outside documents and study specimen procurement and handling.</li></ul><ul><li>
Attends new protocol start-up orientations. Completes required protocol specific training.</li></ul><ul><li>
Assists in preparation of audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits.</li></ul><ul><li>
Completes spreadsheets for industry studies in real time to ensure sponsor is invoiced appropriately and timely.</li></ul><ul><li>
Ensures confidentiality, accuracy, security and appropriate access of all data and records.</li></ul><ul><li>
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.</li></ul>
Preferred Qualifications
Preferred Education: Associate&rsquo;s Degree or combined experience/education as substitute for minimum education
Preferred Experience: Prior experience as a Data Manager in a clinical trials setting
Supervises: N/A
Supervises &ndash; Nature of Work
Preferred Field of Expertise: Data Management
Special Instructions to Applicants:
Applicant Attachments (Required): Resume<div>
Applicant Attachments (Optional): Cover Letter</div>
The hourly rate range for this position is $26.77 - $34.32. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate&rsquo;s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational consideration. 
 
Minimum Education: Associate's degree, Combined experience/education as substitute for minimum education Minimum Experience: 6 months Minimum Field of Expertise: Requires good attention to detail with prior data entry experience. Some knowledge of medical terminology.
<div>Job ID REQ20174848 Posted Date 05/08/2026</div></div>

Clinical Research Data Specialist I

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