clinical trials assistant

Nira Medical

<div>
 Key Responsibilities
 
 
 Clinical &amp; Patient‑Facing Duties
 
 
 <ul>
 <li>
 Obtain and document vital signs (blood pressure, heart rate, temperature, respiratory rate, height, weight) per protocol
 </li>
 <li>
 Perform venipuncture and blood draws for research studies
 </li>
 <li>
 Process, label, centrifuge, store, and ship laboratory specimens according to protocol and laboratory manuals
 </li>
 <li>
 Perform 12‑lead ECGs and ensure accurate transmission and documentation
 </li>
 <li>
 Prepare exam rooms and maintain clinical supplies for study visits
 </li>
 <li>
 Assist with participant flow during research visits and ensure patient comfort and safety
 
 
 </li>
 </ul>
 Research &amp; Data Responsibilities
 
 
 <ul>
 <li>
 Accurately enter clinical and study data into electronic data capture (EDC) systems and/or study databases
 </li>
 <li>
 Maintain source documentation that is complete, accurate, and audit‑ready
 </li>
 <li>
 Assist with informed consent discussions and documentation, as directed
 </li>
 <li>
 Support study visits, screenings, and follow‑ups according to protocol schedules
 </li>
 <li>
 Identify and promptly report protocol deviations, adverse events, and data discrepancies to the study team
 
 
 </li>
 </ul>
 Compliance &amp; Operations
 
 
 <ul>
 <li>
 Follow GCP, IRB, HIPAA, and institutional policies
 </li>
 <li>
 Assist with study regulatory binders and document maintenance
 </li>
 <li>
 Participate in monitoring visits, audits, and inspections as needed
 </li>
 <li>
 Maintain required certifications and training
 
 
 </li>
 </ul>
 
 Required Qualifications
 
 
 
 <ul>
 <li>
 Hands‑on clinical experience performing:
 </li>
 <ul>
 <li>
 Vital signs
 </li>
 <li>
 Venipuncture / blood draws
 </li>
 <li>
 Laboratory specimen processing
 </li>
 <li>
 ECGs
 </li>
 </ul>
 <li>
 High school diploma or equivalent required; Associate&rsquo;s or Bachelor&rsquo;s degree in health sciences, life sciences, or related field preferred
 </li>
 <li>
 Prior experience in clinical research, healthcare, or medical assistant roles
 </li>
 <li>
 Strong attention to detail and documentation accuracy
 </li>
 <li>
 Basic computer proficiency and data entry experience
 </li>
 <li>
 Ability to work independently and as part of a multidisciplinary team
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Medical Assistant certification (CMA, RMA, or equivalent)
 </li>
 <li>
 GCP certification
 </li>
 <li>
 Experience with EDC/eSource systems (e.g., CRIO, Medidata)
 </li>
 <li>
 Prior experience in industry‑sponsored clinical trials
 </li>
 <li>
 Phlebotomy certification
 
 
 </li>
 </ul>
 Physical &amp; Work Requirements
 
 
 <ul>
 <li>
 Ability to stand, walk, and perform clinical procedures for extended periods
 </li>
 <li>
 Ability to lift and move supplies (up to 25 lbs)
 </li>
 <li>
 Comfortable working in a fast‑paced clinical environment
 
 
 </li>
 </ul>
</div>

Research Assistant (Clinical)

Michigan Institute of Urology

<div>Description: 
Elevate Your Career in Healthcare: Join Our Clinical Research Team! 
Michigan Institute of Urology (MIU) is looking for a driven, detail-oriented Clinical Research Assistant to join our growing team.
If you love medical science and patient care and want a professional environment that rewards dedication, this is your opportunity. We are looking to invest in your talent. This position is built for long-term professional development, offering you a concrete career pathway and significant growth potential right here within MIU.<h3 class="jobSectionHeader">
Why You&rsquo;ll Love Working Here</h3>
We believe that exceptional patient care starts with taking care of our team. Enjoy the perfect balance of a high-impact medical career and an incredible personal life:<ul><li>
Status: Full-Time</li><li>
Hours: 8:00 AM &ndash; 5:00 PM, Monday through Friday</li><li>
True Work-Life Balance: Day shifts only &mdash; absolutely no nights, no weekends, and no holidays</li><li>
Work location on site : 130 Town Center Drive, Suite 101, Troy, Michigan 48084</li></ul><h3 class="jobSectionHeader">
Who You Are (The Ideal Candidate)</h3>
This role is tailor-made for an organized professional ready to plant roots in a fast-paced, rewarding environment.<ul><li>
The Perfect Fit: You are a dedicated healthcare professional, medical assistant, or life sciences graduate looking for a career home where you can truly grow.</li><li>
Your Skillset: You possess top-tier administrative skills, sharpness with Microsoft Word and Excel, an eagle eye for detail, and a naturally compassionate demeanor when working with patients.</li><li>
Education &amp; Experience: High School Diploma or equivalent required (Associate&rsquo;s degree or higher in healthcare/science is a plus). Previous healthcare or research assistant experience is strongly preferred.</li></ul><h3 class="jobSectionHeader">
What You'll Do (Key Responsibilities)</h3>
As a vital link in our research department, you will work hand-in-hand with our study coordinators and medical experts to drive clinical trials forward:<ul><li>
Hands-On Clinical Support: Take patient vital signs (blood pressure, pulse, O2 saturation) and handle crucial biological sampling collection, processing, and shipping.</li><li>
Data &amp; Documentation Mastery: Keep our trials running smoothly by managing electronic data entry, resolving data queries, and maintaining pristine study logs.</li><li>
Streamline Operations: Master the workflow by rooming patients, scheduling specialized scans, managing supply chains, and setting up procedure rooms.</li><li>
Maintain Elite Standards: Champion patient privacy (HIPAA) and adhere to standard clinical research training protocols (GCP, IATA, CPR).</li></ul><h3 class="jobSectionHeader">
Top-Tier Compensation &amp; Benefits</h3>
We provide competitive starting pay designed to grow as you do, paired with an excellent benefits package to protect your health and future:<ul><li>
Comprehensive Health Coverage: Excellent medical, dental, vision, and voluntary benefits starting the first of the month following your first 30 days.</li><li>
Invest in Your Future: Secure your retirement with our 401(k) plan, available after 90 days of employment.</li><li>
Immediate Paid Celebrations: Get immediate eligibility for 7 paid holidays starting from day one.</li><li>
Rest &amp; Recharge: Earn paid time off and sick leave immediately. Both start accruing on your very first paycheck and are available to use right away.</li></ul>
GENERAL SUMMARY
The Clinical Research Assistant will play a crucial role in supporting clinical research activities aimed at enhancing medical treatments and therapies. You will work closely with our team of study coordinators and medical professionals to ensure the smooth execution of clinical trials and studies.
Requirements:

ESSENTIAL JOB FUNCTION/COMPETENCIES
Responsibilities include but are not limited to:<ul><li>
Responsible for Study Specific Training which includes initial study start-up information/ requirements, dissemination of updated Investigator&rsquo;s Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study.</li><li>
Collects patient vital signs including height, weight, blood pressure, respirations, pulse temperature, O2 saturation.</li><li>
Source Document Completion which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly.</li><li>
Concomitant Medication Assessment by obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication.</li><li>
Responsible for Biological Sampling Collection/Packaging/Shipping this includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements.</li><li>
Case Report Form (CRF) Entries and Management data entry, query resolution in paper and/or electronic CRFs.</li><li>
Investigational Product (IP) Management &ndash; includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP.</li><li>
Develop and/or Maintain Essential Documents including study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms.</li><li>
Supply Chain Maintenance including supplies inventoried, stocking, organizing, and resupply order placed as required.</li><li>
Responsible for study coordination, rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits.</li><li>
Obtain/Maintain all required training- GCP, IATA,CPR and occasionally help the study coordinators at other offices.</li><li>
Performs other position related duties as assigned.</li><li>
Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.</li></ul>
CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS<ul><li>
N/A</li></ul>
KNOWLEDGE | SKILLS | ABILITIES<ul><li>
Ability to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work.</li><li>
Proficiency skills with Microsoft Word and Excel.</li><li>
Excellent computer skills.</li><li>
Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff.</li></ul>
EDUCATION REQUIREMENTS<ul><li>
High School Diploma or equivalent required.</li><li>
Associate's degree or higher in a related field (biology, psychology, nursing or healthcare) preferred.</li></ul>
EXPERIENCE REQUIREMENTS<ul><li>
Previous healthcare experience strongly preferred.</li><li>
Previous Research Assistant experience preferred.</li></ul>
REQUIRED TRAVEL<ul><li>
Minimal travel required.</li></ul>
PHYSICAL DEMANDS
Carrying Weight Frequency
1-25 lbs. Frequent from 34% to 66%
26-50 lbs. Occasionally from 2% to 33%
Pushing/Pulling Frequency
1-25 lbs. Seldom, up to 2%
100 + lbs. Seldom, up to 2%
Lifting - Height, Weight Frequency
Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%
Floor to Chest, 26-50 lbs. Seldom: up to 2%
Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%
Floor to Waist, 26-50 lbs. Seldom: up to 2%</div>

Clinical Research Assistant

Teak Research Consults

Teak Research Consults specializes in Phase II- IV with two locations in Lawrenceville and Dunwoody GAJob Summary The Clinical Trials Coordinator is responsible for the day‑to‑day execution of clinical research activities in accordance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. With a minimum of three years of hands‑on clinical trial coordination experience, this role ensures the smooth conduct of study visits, accurate documentation, timely data entry, and effective communication with participants, investigators, and study sponsors. The coordinator supports all operational aspects of assigned studies&mdash;including screening, enrollment, visit management, safety reporting, and regulatory compliance&mdash;while maintaining high standards of professionalism, organization, and participant care. This position requires strong attention to detail, the ability to manage multiple priorities, and a commitment to supporting high‑quality clinical research.Responsibilities<ul><li>Coordinate all aspects of clinical trials, ensuring adherence to protocols and regulatory guidelines.</li><li>Monitor patient progress and safety throughout the study, including conducting vital signs assessments and managing patient documentation.</li><li>Review and maintain accurate documentation related to clinical trials, including data collection and management.</li><li>Collaborate with cross-functional teams to ensure compliance with FDA regulations and standards.</li><li>Handling, packaging, and shipping of processed lab samples</li><li>Handling, storing, and processing study drug</li><li>Creating source document</li><li>Conduct patient recruitment, screening, and informed consent processes while adhering to HIPAA regulations.</li><li>Manage clinical laboratory activities, including blood sampling and phlebotomy as required by the study protocols.</li><li>Ensure proper training of staff on clinical trial procedures and compliance management.</li><li>Informed consenting process</li><li>Screening of research patient to determine eligibility</li><li>Vast Knowledge in electronic Clinical Outcome Assessment</li></ul>Qualifications<ul><li>3+ years research experience</li><li>Associates/ Bachelor's degree in a scientific, health related (preffered) or relevant experience in lieu of education</li><li>Strong background in clinical trials management with knowledge of Good Clinical Practice (GCP).</li><li>Familiarity with medical terminology, FDA regulations, and compliance requirements.</li><li>Experience in documentation review, patient monitoring, data collection, and data management.</li><li>Proficiency in using electronic medical record (EMR) systems and statistical software for data analysis.</li><li>Skills in phlebotomy and blood sampling techniques.</li><li>Excellent analytical skills with the ability to interpret complex data sets effectively.</li><li>Knowledge of clinical development processes and the ability to work collaboratively within a research setting. This role is essential for advancing clinical research initiatives while ensuring the highest standards of patient care and regulatory compliance.</li><li>Good communication, organization, and interpersonal skills</li><li>Good computer skills including working knowledge of a PC and Microsoft office</li><li>In depth knowledge of state and federal Regulatory guidelines related to research</li><li>Applicants residing in the Atlanta area are strongly preferred.</li></ul>Job Types: Part-time, ContractPay: From $24.00 per hourBenefits:<ul><li>Referral program</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>Clinical research: 3 years (Required)</li><li>Clinical trials management: 3 years (Preferred)</li></ul>Ability to Commute:<ul><li>Lawrenceville, GA 30043 (Required)</li></ul>Work Location: In person

Clinical Trials Coordinator

Care Access

<div>
 
 About Care Access
 
 
 
 Care Access is working to make the future of health better for all.
 
 With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.
 
 We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need,
 
 and contribute to the medical breakthroughs of tomorrow.
 
 
 
 With programs like
 
 Future of Medicine
 
 , which makes advanced health screenings and research opportunities accessible to communities worldwide, and
 
 Difference Makers
 
 , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
 
 
 To learn more about Care Access, visit www.CareAccess.com.
 
 
 
 How This Role Makes a Difference
 
 
 
 The
 
 Clinical Research
 
 
 Assistant
 
 is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization.
 
 
 
 How You'll Make An Impact
 
 
 
 <ul>
 <li>
 Ability to understand and follow institutional SOPs
 </li>
 <li>
 Participate in recruitment and pre-screening events (may be at another location)
 </li>
 <li>
 Assist with preparation of outreach materials
 </li>
 <li>
 Identify potential participants by reviewing medical records, study charts and subject database
 </li>
 <li>
 Assist with recruitment of new participants by conducting phone screenings
 </li>
 <li>
 Request medical records of potential and current research participants
 </li>
 <li>
 Schedule visits with participants, contact with reminders
 </li>
 <li>
 Obtain informed consent per Care Access Research SOP, under the direction of the CRC
 </li>
 <li>
 Complete visit procedures as required by protocol, under the direction of the CRC
 </li>
 <li>
 Collect, process and ship specimens as directed by protocol, under the direction of the CRC
 </li>
 <li>
 Record data legibly and enter in real time on paper or e-source documents
 </li>
 <li>
 Request study participant payments
 </li>
 <li>
 Update all applicable internal trackers and online recruitment systems
 </li>
 <li>
 Assist with query resolution
 </li>
 <li>
 Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc.
 </li>
 <li>
 Assist with maintaining all site logs
 </li>
 <li>
 Assist with inventory and ordering equipment and supplies
 </li>
 <li>
 Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
 </li>
 <li>
 Maintain effective relationships with study participants and other care Access Research personnel.
 </li>
 <li>
 Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.
 </li>
 <li>
 Communicate clearly verbally and in writing.
 </li>
 <li>
 Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 
 
 </li>
 </ul>
 
 The Expertise Required
 
 
 
 <ul>
 <li>
 Bilingual in Spanish required
 </li>
 <li>
 Ability and willingness to work independently with minimal supervision
 </li>
 <li>
 Ability to learn to work in a fast-paced environment
 </li>
 <li>
 Excellent communication skills and a high degree of professionalism with all types of people
 </li>
 <li>
 Excellent organizational skills with strong attention to detail
 </li>
 <li>
 A working knowledge of medical and research terminology
 </li>
 <li>
 A working knowledge of federal regulations, Good Clinical Practices (GCP)
 </li>
 <li>
 Critical thinker and problem solver
 </li>
 <li>
 Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
 </li>
 <li>
 Contribute to team and site goals
 </li>
 <li>
 Proficiency in Microsoft Office Suite
 </li>
 <li>
 High level of self-motivation and energy
 </li>
 <li>
 An optimistic, &ldquo;can do&rdquo; attitude
 
 
 </li>
 </ul>
 
 Certifications/Licenses, Education, And Experience
 
 
 
 <ul>
 <li>
 A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist.
 </li>
 <li>
 Phlebotomy Experience and Proficiency Required
 </li>
 <li>
 Some Clinical Research experience preferred
 
 
 </li>
 </ul>
 
 How We Work Together
 
 
 
 <li>
 Location: This is an on-site position with regional commute requirements.
 </li>
 Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
 <li>
 Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
 
 
 </li>
 The expected salary range for this role is $19.00 - $33.00 USD per hour for full time team members.
 
 
 
 Benefits &amp; Perks (US Full Time Employees)
 
 
 
 <ul>
 <li>
 Paid Time Off (PTO) and Company Paid Holidays
 </li>
 <li>
 100% Employer paid medical, dental, and vision insurance plan options
 </li>
 <li>
 Health Savings Account and Flexible Spending Accounts
 </li>
 <li>
 Bi-weekly HSA employer contribution
 </li>
 <li>
 Company paid Short-Term Disability and Long-Term Disability
 </li>
 <li>
 401(k) Retirement Plan, with Company Match
 
 
 </li>
 </ul>
 
 Diversity &amp; Inclusion
 
 
 
 We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
 
 
 We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
 
 
 Care Access is unable to sponsor work visas at this time.
 
 
 If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
 
 
 
 Mandatory Employer Disclosures
 
 
 
 
 Notice to Illinois applicants:
 
 Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
 
 
 
 Notice to Connecticut applicants:
 
 Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
 
 
 
 Notice to Arizona, Georgia, Indiana, and North Dakota applicants:
 
 Care Access complies with applicable laws prohibiting smoking in and around places of employment.
 
 
 
 Notice to Massachusetts applicants:
 
 It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
 
 
 
 Notice to Rhode Island applicants:
 
 Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29&ndash;38 of Title 28 of the Rhode Island General Laws.
 
 
 
 Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
 
</div>

UT Southwestern Medical Center

WHY UT SOUTHWESTERN?
 With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
 
JOB SUMMARY
 Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead.
 This position will be responsible for preparing statistical information for each subject entered in or removed from our research studies. They identify subjects for the studies by means of reviewing charts to see if criteria is met. This position also prepares data for IRB and submits confidential records and research materials.
 
BENEFITS
 UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
 PPO medical plan, available day one at no cost for full-time employee-only coverage
 100% coverage for preventive healthcare-no copay
 Paid Time Off, available day one
 Retirement Programs through the Teacher Retirement System of Texas (TRS)
 Paid Parental Leave Benefit
 Wellness programs
 Tuition Reimbursement
 Public Service Loan Forgiveness (PSLF) Qualified Employer
 Learn more about these and other UTSW employee benefits!
 
EXPERIENCE AND EDUCATION
 
Required
 Education
 High School Diploma or
 Associate's Degree in medical or science related field or
 Bachelor's Degree medical or science related field and no prior experience
 
Experience
 2 years experience with High School Diploma or
 1 year experience with Associate's Degree
 
Preferred
 
Education
 
Bachelor's Degree in medical or science related field
 
Experience
 
Patient-facing experience such as Medical Assistant, Phlebotomist, Scribe or similar.
 
Licenses and Certifications
 (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements.
 (CPRAED) CPR AED may be required based on affiliate location requirements.
 
JOB DUTIES
 Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
 Assists research staff by completing research protocol related tasks.
 Reviews and abstracts information from medical records including eligibility criteria.
 Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation.
 Assists with data queries and possible edits for accuracy.
 Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions.
 Maintains existing databases and ensures data integrity.
 Performs QA/QC clinical analysis and data checks using various databases based on trial.
 Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
 Assist and prepare research records for formal sponsor audits or internal audits.
 Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
 With adequate training and supervision, assists with participant screening and recruitment for more complex trials.
 Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants.
 Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.
 Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
 With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols.
 Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor).
 With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required.
 May perform patient care (basic skills) under the direction of PI following scope of work document.
 Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
 Performs other duties as assigned.
 SECURITY AND EEO STATEMENT
 
Security
 This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
 
EEO
 UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.

Clinical Research Assistant II, Endocrinology

Children's National Hospital

<div>
 The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.
 
 
 
 Minimum Education
 
 
 
 BA/BS degree in a science, technical, health-related field or another applicable
 
 
 discipline. (Required)
 
 
 
 Minimum Work Experience
 
 
 
 0 years Experience working in a medical or scientific research setting (Preferred)
 
 
 
 Functional Accountabilities
 
 
 
 
 Responsible Conduct of Research
 
 
 
 <ul>
 <li>
 Consistently demonstrates adherence to the standards for the responsible conduct of research.
 </li>
 <li>
 Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
 </li>
 <li>
 Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
 </li>
 <li>
 Uses research funds and resources appropriately.
 </li>
 <li>
 Maintains confidentiality of data as required.
 </li>
 <li>
 Meets all annual job-related training and compliance requirements.
 
 
 </li>
 </ul>
 
 Research Administration
 
 
 
 <ul>
 <li>
 Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
 </li>
 <li>
 Accurately creates, completes, maintains and organizes study documents.
 </li>
 <li>
 Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
 </li>
 <li>
 Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
 </li>
 <li>
 Attends study meetings, which could include overnight travel, as requested by principal investigator.
 </li>
 <li>
 Works well with other members of the research team and seeks and provides input when appropriate.
 
 
 </li>
 </ul>
 
 Participant Enrollment
 
 
 
 <ul>
 <li>
 Adheres to the IRB-approved recruitment plan.
 </li>
 <li>
 Identifies participants that meet eligibility requirements under the supervision of a senior research team member.
 </li>
 <li>
 Screens subjects for eligibility per the protocol and institutional policies.
 </li>
 <li>
 Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
 </li>
 <li>
 Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
 </li>
 <li>
 Engages participants/LARs in the informed consent process according to institutional policies.
 </li>
 <li>
 Follows procedures for documenting participant incentive distribution.
 
 
 </li>
 </ul>
 
 Study Management
 
 
 
 <ul>
 <li>
 Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
 </li>
 <li>
 Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
 </li>
 <li>
 Completes accurate IRB submissions within institutional timeframes.
 </li>
 <li>
 Records participant visits in the appropriate tracking system.
 </li>
 <li>
 Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
 
 
 </li>
 </ul>
 
 Data Collection
 
 
 
 <ul>
 <li>
 Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
 </li>
 <li>
 Ensures that queries are resolved within sponsor and institutional timelines.
 </li>
 <li>
 Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
 </li>
 <li>
 Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.
 </li>
 <li>
 Anticipate and responds to customer needs; follows up until needs are met
 
 
 </li>
 </ul>
 Teamwork/Communication
 
 
 <ul>
 <li>
 Demonstrate collaborative and respectful behavior
 </li>
 <li>
 Partner with all team members to achieve goals
 </li>
 <li>
 Receptive to others&rsquo; ideas and opinions
 
 
 </li>
 </ul>
 Performance Improvement/Problem-solving
 
 
 <ul>
 <li>
 Contribute to a positive work environment
 </li>
 <li>
 Demonstrate flexibility and willingness to change
 </li>
 <li>
 Identify opportunities to improve clinical and administrative processes
 </li>
 <li>
 Make appropriate decisions, using sound judgment
 
 
 </li>
 </ul>
 Cost Management/Financial Responsibility
 
 
 <ul>
 <li>
 Use resources efficiently
 </li>
 <li>
 Search for less costly ways of doing things
 
 
 </li>
 </ul>
 Safety
 
 
 <ul>
 <li>
 Speak up when team members appear to exhibit unsafe behavior or performance
 </li>
 <li>
 Continuously validate and verify information needed for decision making or documentation
 </li>
 <li>
 Stop in the face of uncertainty and takes time to resolve the situation
 </li>
 <li>
 Demonstrate accurate, clear and timely verbal and written communication
 </li>
 <li>
 Actively promote safety for patients, families, visitors and co-workers
 </li>
 <li>
 Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
 
 
 </li>
 </ul>
 The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.
 
 
 
 Primary Location
 
 
 
 District of Columbia-Washington
 
 
 
 Work Locations
 
 
 
 CN Hospital (Main Campus)
 
 
 
 Organization
 
 
 
 Surgery COE
 
 
 
 Position Status
 
 
 
 R (Regular)
 
 
 
 Shift
 
 
 
 Day
 
 
 
 Work Schedule
 
 
 
 8a-430p
 
 
 
 Job Posting
 
 
 
 Jun 12, 2026, 8:37:05 PM
 
 
 
 Full-Time Salary Range
 
 
 
 42702.4
</div>

Quotient Sciences

<div>
 
 Quotient Sciences: Molecule to Cure. Fast.
 
 
 
 Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
 
 
 Our proprietary and disruptive platform &ndash; &ldquo;Translational Pharmaceutics&reg;&rdquo; &ndash; integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn
 
 reduces costs
 
 , improves outcomes, and significantly accelerates drug development times.
 
 
 
 Why Join Us
 
 
 
 Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact&mdash;fast.
 
 
 
 The Role
 
 
 
 <ul>
 <li>
 Responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects
 </li>
 <li>
 To comply &amp; adhere to GCP guidelines and regulations as required of this role
 
 
 </li>
 </ul>
 
 Main Tasks And Responsibilities
 
 
 
 <ul>
 <li>
 Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables.
 </li>
 <li>
 Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats.
 </li>
 <li>
 Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff.
 </li>
 <li>
 Maintain training logs and ensure training compliance for all personnel listed on delegation logs.
 </li>
 <li>
 Manage file note control, including creation, review, and filing.
 </li>
 <li>
 Ensure all regulatory documentation is audit-ready and compliant with archiving requirements.
 </li>
 <li>
 Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
 </li>
 <li>
 Process Spanish regulatory documents and communicate approvals to the screening team.
 </li>
 <li>
 Notify staff of updated or newly released documents via secure file systems.
 </li>
 <li>
 Support the Project Management team with PSA activities, revenue forecasting, and invoicing.
 </li>
 <li>
 Assist with study closeout activities, including budget reconciliation and archiving.
 </li>
 <li>
 Maintain and perform quality control (QC) of the volunteer clinical RSVP database.
 </li>
 <li>
 Manage laboratory requisitions and collaborate with Data Management to support query resolution.
 </li>
 <li>
 Support eSource User Acceptance Testing (UAT) activities.
 </li>
 <li>
 Assist with the hosting and support of sponsor monitors during site visits and with related action items
 
 
 </li>
 </ul>
 
 Job Demands
 
 
 
 <ul>
 <li>
 The job may involve the following:
 </li>
 <ul>
 <li>
 Very high concentration of work
 </li>
 <li>
 Strict and tight deadlines
 </li>
 <li>
 Having to juggle a range of tasks/issues simultaneously
 </li>
 <li>
 Working in a hazardous environment with high requirement to follow safety procedures
 </li>
 <li>
 Working outside normal working hours
 </li>
 <li>
 Needing to respond to client demands
 
 </li>
 </ul>
 </ul>
 
 The Candidate
 
 
 
 <ul>
 <li>
 Minimum Degree qualification or equivalent
 </li>
 <li>
 Relevant work experience in a pharmaceutical company/CRO would be an advantage
 </li>
 <li>
 Computer literate, proficient in Microsoft Windows
 </li>
 <li>
 Proficient in Information Technology
 </li>
 <li>
 Highly organized and efficient
 </li>
 <li>
 Ability to communicate effectively; people-oriented personality
 
 
 </li>
 </ul>
 
 Application Requirements
 
 
 
 When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
 
 
 
 Our Commitment to Diversity, Equity and Inclusion
 
 
 
 Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
 
 
 Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
 
 
 This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
</div>

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