clinical studies specialist

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

Temple University Health System

<div></div><div><div>Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Clinical Research Coordinator Department is searching for a Clinical Research Specialist-Katz 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! 
Click here to learn more about the benefits of working at Temple University.
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.
This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.<div>
Job Details: 
<ul><li>This position will be on-site</li><li>This position requires the following background checks: PII/Cash Handling</li><li>This is a grant funded position</li></ul></div>
Position Summary: 
The Clinical Research Specialist works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured career ladder.
At Temple University&rsquo;s Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine.
This is a grant-funded position and requires a background check. Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. Hybrid work options may be considered depending on study and departmental needs.<div>
Required Education and Experience: 
<ul><li>Bachelor'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>
Responsibilities: 
The Clinical Research Specialist supports study coordination activities under the direction of senior staff, following established protocols and procedures. The Specialist performs routine tasks to help ensure the accurate and compliant execution of clinical research projects and refers decisions requiring interpretation of policies or procedures to the Clinical Research Coordinator or other supervisors.<ul><li>Perform day-to-day activities of all assigned research projects and clinical trials.</li><li>Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits.</li><li>Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data.</li><li>Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data.</li><li>Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders.</li><li>Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects.</li><li>May submit IRB paperwork to ensure compliance with IRB regulations.</li><li>Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.</li></ul><div>
Other duties and responsibilities: 
<ul><li>May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.</li><li>Performs other duties as assigned.</li></ul></div><div>
Required Skills and Abilities: 
<ul><li>Demonstrated computer skills, and proficiency with MS Office Suite software programs.</li><li>Aptitude in professionalism</li><li>Excellent written and oral communications skills</li><li>Ability to work evenings/weekends hours as needed.</li><li>Knowledge of medical terminology</li><li>Able to resolve problems/issues</li><li>Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants</li><li>Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously.</li><li>Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.</li><li>Ability to travel to off-site locations that may not be accessible via public transportation.</li><li>Strong time management skills</li></ul></div><div>
Preferred Skills and Abilities: 
<ul><li>Knowledge of IRB and human subject protection</li><li>Prior experience with IRB submissions.</li><li>Prior experience processing and shipping biological samples.</li><li>Prior phlebotomy certification or willing to learn.</li><li>Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders.</li><li>Prior Electronic Data Capture (eDC) data entry skills.</li><li>Prior research experience in a healthcare setting.</li><li>Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies.</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. Click here.
You may request a copy of the report by calling Temple University&rsquo;s Department of Public Safety at 215-204-7900.</div></div>

Clinical Research Specialist-Katz

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

<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>

Clinical Research Specialist

University of Maryland, Baltimore

<div></div><div><div>The Division of Transplant Surgery at the University of Maryland, Baltimore (UMB) are currently seeking a FULL-TIME Clinical Research Specialist to join their fast-paced, high-reward clinical research team.
The University of Maryland organ transplant center is one of the largest in the United States, performing more than 400 transplants per year, including 300 kidneys, 80 livers, 20 pancreas, and 45 thoracic transplants. The clinical center receives more than 1,500 new patient referrals each year and follows more than 4,800 patients who have been transplanted over the last two decades, as well as more than 1,400 patients on the organ transplant waiting lists. 
Our leaders hold national and international prominence in their fields and have translated their discoveries into clinical management guidelines. We are one of only two transplant centers serving more than 5 million people in Maryland.
The position is responsible for assisting with coordinating the day-to-day operations of one or more research studies or clinical trial protocols. The position coordinates data collection and maintenance, project evaluation, meeting scheduling, and research subject interfacing. The Clinical Research Project Assistant adheres to good clinical practices, study protocols, and applicable regulations, conducts complex work, contributes to measurable team objectives, and uses discretion to solve issues. The position will work in the Division of Transplant Surgery at the University of Maryland, Baltimore School of Medicine. The division of Transplant Surgery is located within the School of Medicine at the University of Maryland, Baltimore, and maintains a large research portfolio involving the heart, lung, liver, kidney, and pancreas. 
BENEFITS (Exempt Regular):
UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave days, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).
UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland. 
PRIMARY DUTIES<ul><li>
Performs as a single specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. This position significantly contributes to the conduct of research.</li><li>
Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities. 
<ul><li>Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. May obtain tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.</li></ul></li><li>
Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning. Check validity and accuracy of data ensuring compliance with quality control requirements and study relevance.</li><li>
Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data. May develop data collection instruments such as survey questionnaires.</li><li>
Maintains communication with participants and colleagues regarding protocol specific information and research orders. Provides assessments and ensure protocol compliance while participants are in a study.</li><li>
Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.</li><li>
Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion. Assist in the design and provide expert recommendation regarding research studies. Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.</li><li>
May provide working coordination and feedback to others</li><li>
Performs day-to-day operational duties such as: monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.</li><li>
Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. May conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.</li><li>
Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies; developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.</li><li>
Performs other duties as assigned.</li></ul><div>
</div></div><div>
Qualifications<div></div> 
MINIMUM QUALIFICATIONS
Education: Bachelor's degree in a scientific field of study related to the research of the clinical setting.
Experience: Three (3) years clinical research including two (2) years in the relevant research specialization.
Supervisory Experience: N/A
Certification/Licensure: N/A
Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted. 
KNOWLEDGE, SKILLS, ABILITIES
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery. 
HIRING RANGE: $64,000 - $75,000 per year / Commensurate with education and experience 
UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.
If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request. You may also contact leave_and_accom@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.
The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.<div> 
</div></div><div>
Job: Reg or CII Exempt Staff - E3304E</div><div>
Employee Class : Exempt Regular</div><div>
Full Time/Part Time: Full-Time</div><div>
Shift: Day Job</div><div>
Financial Disclosure: No</div><div>
Organization: School of Medicine - Surgery</div><div>
Job Posting: Apr 7, 2026</div><div>
Unposting Date: Apr 15, 2026, 10:59:00 PM</div></div>

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

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>

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