study 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

UniTriTeam

<div>EDC Data Entry Specialist (Remote &ndash; PST/CST/EST Hours) 


Company: 
UniTriTeam &ndash; Supporting Clinical Research Excellence

About the Role 
UniTriTeam is hiring for multiple remote EDC Data Entry Specialist roles to support our clinical research clients across the U.S. These full-time remote positions require availability during standard business hours in Pacific (PST), Central (CST), or Eastern (EST) time zones.

We're looking for meticulous, detail-oriented professionals with a medical background and a passion for data accuracy. In this role, you'll be responsible for entering and verifying clinical trial data in EDC systems, maintaining the highest standards of data integrity.

Key Responsibilities
<ul>
<li>Accurately enter clinical trial data into Electronic Data Capture (EDC) systems in compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.</li>
<li>Perform validation and quality checks to ensure data completeness and accuracy.</li>
<li>Work collaboratively with clinical research coordinators and site staff to resolve discrepancies.</li>
<li>Maintain strict confidentiality and security of all clinical trial data.</li>
<li>Generate data reports and summaries for site and study team review as needed.</li>
<li>Keep current on all study-related documents and database/system updates.</li>
<li>Complete all study-required trainings as instructed by the clinical research site team.</li>
<li>Follow all Standard Operating Procedures (SOPs) and suggest improvements to optimize workflows.</li>
</ul>
Required Qualifications
<ul>
<li>Education &amp; Experience</li>
<li><ul><li>Medical background (degree or relevant professional experience) is required.</li>
<li>Prior data entry experience in clinical research or healthcare is highly preferred.</li>
</ul></li><li>Technical Skills</li>
<li><ul><li>Experience with EDC platforms such as Medidata RAVE, REDCap, or similar systems is highly preferred.</li>
<li>Proficiency with Microsoft Office Suite (Word, Excel, Outlook).</li>
</ul></li><li>Core Competencies</li>
<li><ul><li>Excellent attention to detail and high degree of accuracy.</li>
<li>Ability to work under tight deadlines in a regulated environment.</li>
<li>Effective communication skills and a collaborative spirit.</li>
<li>Familiarity with clinical trial processes and medical terminology is a plus.</li>
</ul></li>
</ul>Why Join Us? 
UniTriTeam is a global leader in providing operational, administrative, and technology support to clinical research sites. We take pride in our mission to help advance medicine and make a real impact in healthcare. By joining our team, you'll benefit from:
<ul>
<li>A collaborative and supportive work environment</li>
<li>Opportunities for professional growth and advancement</li>
<li>A chance to be part of meaningful research initiatives that change lives</li></ul></div>

EDC Data Entry Specialist

University of Maryland, Baltimore

<div></div><div><div>The Pulmonary, Critical Care, and Sleep Medicine Division has an exciting opportunity for a Contractual Clinical Research Specialist or a Senior Clinical Research Assistant to join our fun and productive team. This will be an excellent opportunity for an individual seeking stability and/or professional advancement.
Benefits: Contingent Category II
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. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB; life insurance and long-term disability; 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
Contractual Senior Clinical Research Assistant<ul><li>
Responsible for facilitating and coordinating clinical research patient visits and data collection. The position will support the conduct of clinical trials, including the coordination of start-up activities, scheduling and preparing for patient visits, assisting with data collection and clarification, and general administrative duties.</li><li>
Assist in 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. May assist in developing and recommending policies and procedures and/or design methods for clinical research activities.</li><li>
Coordinates data collection of the research study including obtaining medical records, lab results, diagnostic results, visit notes, etc. Coordinates recruitment and screening subjects for research studies according to IRB approved protocols. May communicate directly with study participants.</li><li>
Coordinates paperwork for submission of IRB protocol, IRB amendments, and IRB continuing reviews. Document and report all adverse events as appropriate. Participates in audits and monitor visits as needed according to policy.</li><li>
Performs the coordination of data analysis and interpretation and develops statistical reports of study data using descriptive statistics using SAS, STATA, and SPSS statistical software. Assists in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations. Conducts and analyzes literature searches. Develops and establishes a database to track research data.</li><li>
Coordinates development of research protocols and materials by providing study analysis and forming conclusions and recommendations.</li><li>
Documents in accordance with state and federal standards pertaining to specific research participant enrolled in the study. 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>
Performs other duties as assigned.</li></ul>
OR
PRIMARY DUTIES
Contractual Clinical Research Specialist<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.</li><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><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 recommendations 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. 
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> 
Contractual Senior Clinical Research Assistant
Education: Bachelor&rsquo;s degree in a scientific field of study related to the research of the clinical setting.
Experience: Two (2) years of experience in clinical research in research being performed in unit.
Other: May consider a combination of directly related experience and education
OR
Contractual Clinical Research Specialist
Education: Bachelor&rsquo;s degree in a scientific field of study related to the research of the clinical setting.
Experience: Three (3) years of experience in clinical research including two (2) years in the relevant research specialization.
Other: May consider a combination of directly related experience and education
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 Ranges: Commensurate with education and experience
Contractual Senior Clinical Research Assistant: $57,500 - $60,000
Contractual Clinical Research Specialist: $64,000 - $75,000
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 - E3302D</div><div>
Employee Class Exempt Contingent II</div><div>
Full Time/Part Time: Full-Time</div><div>
Shift: Day Job</div><div>
Financial Disclosure: No</div><div>
Organization: School of Medicine - Department of Medicine</div><div>
Job Posting: May 5, 2026</div><div>
Unposting Date: May 19, 2026, 10:59:00 PM</div></div>

OPEN RANK Contractual Senior Clinical Research Assistant or Contractual Clinical Research Specialist

Seton Hall University

<div>EOP/ LEAP Center Peer Tutor 2026-27<div> 

Job no: 497251 
Full time/Part time: Part-time 
Location: South Orange 
Categories: Student Employment 
</div>
<div><div><div><div><div>JOB SUMMARY</div> 
<div>
Peer Tutors provide academic support and assistance to fellow students within a specific subject area (Business (all areas), Mathematics at all levels, Statistics (Social Sciences Majors, Science Majors), Sciences (Biology, Chemistry, and Physics), English, Languages (German, Italian, French, Spanish), Core and Humanities (History, Psychology, Sociology, etc.) or multiple subjects. This role involves facilitating learning, reinforcing course material, and helping students develop effective study skills. Peer tutors serve as mentors and guides, fostering a collaborative learning environment that encourages student success.</div></div> 
<div>
<div>DUTIES &amp; RESPONSIBILITIES</div> 
<div>
<ul><li>Provided academic assistance to the Educational Opportunity Program (EOP) students throughout the academic year.</li></ul>
<ul><li>Conduct one-on-one or small-group tutoring sessions with students seeking assistance in the designated subject area(s).</li></ul>
<ul><li>Clarify course concepts, review homework assignments, and help students prepare for exams.</li></ul>
<ul><li>Adapt tutoring techniques to accommodate diverse learning styles and individual student needs.</li></ul>
<ul><li>Provide clear explanations and examples to aid student understanding of complex topics.</li></ul>
<ul><li>Offer guidance on note-taking, reading comprehension, and exam preparation methods.</li></ul>
<ul><li>Direct students to supplement their learning with additional resources, such as online tutorials or academic support services.</li></ul>
<ul><li>Maintain accurate records of tutoring sessions, including student attendance, topics covered, and progress made.</li></ul></div></div> 
<div>
<div>REQUIRED QUALIFICATIONS</div> 
<div>
<ul><li>Currently enrolled undergraduate student</li></ul>
<ul><li>Proficiency in the subject(s) you wish to tutor, with an A or B+ in the courses</li></ul>
<ul><li>Excellent communication and interpersonal skills</li></ul>
<ul><li>Patience, empathy, and the ability to work effectively with diverse student populations</li></ul>
<ul><li>Mandatory training in the Fall and Spring semesters.</li></ul>
<ul><li>Be eligible for Federal Work Study</li></ul></div></div> 
<div>
<div>DESIRED QUALIFICATIONS</div> 
<div>
Knowledge of EOP programs at Seton Hall</div></div> 
<div>
<div>CONTACT</div> 
<div>
Tamela D. Culp,

EOP Educational Specialist

973-761-9425</div></div> 
<div>
<div>FEDERAL WORK STUDY ELIGIBILITY</div> 
<div>
YES &ndash; 2026/27 Federal Work Study eligibility required (check your Financial Aid Offer on the University Portal)</div></div> 
</div>
</div>Seton Hall University is committed to programs of Equal Employment Opportunity (EEO).
</div>
Advertised: 23 Apr 2026 Eastern Daylight Time 
Applications close: 02 Oct 2026 Eastern Daylight Time</div>

EOP/ LEAP Center Peer Tutor 2026-27

Valiance clinical research

Job Title: Clinical Data Entry &amp; Data Management Specialist Company: Valiance Clinical Research Location: Valencia Job Type: Full-TimeAbout Us: Valiance Clinical Research is a modern clinical research organization focused on delivering high-quality, efficient trials through strong data integrity and operational excellence. We partner with sponsors and CROs to support accurate, compliant, and timely study execution.Position Overview: We are seeking a detail-oriented Clinical Research Data Entry &amp; Data Management Coordinator to support our research team. This role is responsible for accurate and timely data entry, data validation, and maintaining high-quality clinical trial records in compliance with regulatory standards.Key Responsibilities:<ul><li>Enter clinical trial data into electronic data capture (EDC) systems</li><li>Review source documents for accuracy and completeness</li><li>Perform data verification and resolve discrepancies/queries</li><li>Maintain organized and audit-ready study records</li><li>Ensure compliance with GCP, HIPAA, and study protocols</li><li>Collaborate with site staff to ensure timely and accurate data reporting</li></ul>Qualifications:<ul><li>High school diploma or equivalent required; associate or bachelor&rsquo;s degree preferred</li><li>Previous data entry or administrative experience required (clinical research experience a REQUIRED)</li><li>Strong attention to detail and accuracy</li><li>Familiarity with EDC systems is a REQUIRED</li><li>Proficiency in eSources and CTMS is REQUIRED</li><li>Ability to manage deadlines and prioritize tasks effectively</li></ul>Why Join Us:<ul><li>Entry point into the clinical research industry</li><li>Supportive and collaborative work environment</li><li>Opportunities for growth within clinical research</li><li>Competitive compensation and benefits</li></ul>Apply Today: Submit your resume via Indeed to join Valiance Clinical Research and contribute to high-quality clinical data that drives medical innovation.Pay: $22.00 - $25.00 per hourBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Vision insurance</li></ul>Application Question(s):<ul><li>Experience with iMedidata, Veeva, Oracle, iMedNet, and other EDC vendors?</li><li>Experience with eSources?</li></ul>Work Location: In person

Clinical Research Data Entry & Data Management Coordinator

Stryker

<div><h3 class="jobSectionHeader">Why join Stryker?</h3>
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. 
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards &ndash; not to mention various social and recreational activities, all of which are location specific.<h3 class="jobSectionHeader">
Job description</h3>
We are excited to be named one of the World&rsquo;s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.<div>
Stryker is hiring a Preclinical Specialist for our Neurovascular division. This is an onsite role based in Fremont, CA.
As the Preclinical Specialist, you will support the planning and execution of high-quality preclinical performance studies to assess the safety and effectiveness of Stryker Neurovascular devices. Working with guidance from the preclinical research team, you will assist with study logistics, data collection, and practical problem solving to help set up and troubleshoot test environments (in vitro, imaging, and lab setups) across product development and business continuity programs.
What you will do<ul><li>
Maintain preclinical lab scheduling, maintenance, and readiness activities to help ensure a safe and organized working environment, including basic troubleshooting of equipment and test setups with guidance.</li><li>
Support onsite and offsite study activities by helping align schedules, confirming training status, and maintaining readiness and compliance requirements. Support the development, review, and execution of preclinical protocols under the direction of the preclinical research team, applying Stryker Neurovascular Quality principles.</li><li>
Support hands‑on product evaluation and in vitro modeling activities with R&amp;D and Marketing by following established procedures and communicating status to the preclinical team.</li><li>
Assist with assigned preclinical study tasks across New Product Development and Business Continuity projects, including data collection and accurate documentation, with guidance.</li><li>
Coordinate competitive product purchasing and help with consultant contracting and invoicing; provide cost inputs and status updates as requested.</li><li>
Develop skills to compile and summarize observations and data from preclinical studies by identifying test‑environment issues (test setups, equipment, lab/imaging conditions), and escalating questions with supporting data to the appropriate stakeholders to enable timely resolution.</li><li>
Develop skill in providing input on study model selection (animal, bench, cadaver) by gathering relevant information and sharing it with the preclinical researcher/core team.</li></ul>
What you need
Required<ul><li>
High school diploma plus 6 years of relevant experience, or</li><li>
Associate degree plus 4 years of relevant experience, or</li><li>
Bachelor&rsquo;s degree in biomedical, science, or a healthcare‑related field.</li></ul>
Preferred<ul><li>
Technical aptitude and hands‑on laboratory operations experience.</li><li>
Ability to follow documented procedures, maintain training compliance, and produce accurate records with guidance.</li></ul>
Physical requirements<ul><li>
Medium work, including exerting up to 20 pounds of force.</li><li>
Ability to wear radiation protection clothing and stand for extended periods (up to ~8 hours/day as needed).</li><li>
Open to domestic and international travel (up to 30%) to support projects as needed.</li></ul><ul><li> 
US30: $94,300 - $157,200 USD Annual</li></ul></div>
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&amp;D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.</div>

Preclinical 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

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