Clinical Research Associate Jobs in Kingsport, TN

Are you a clinical operations pro ready to make your mark at a fast-growing, cutting-edge research network? We're on the hunt for a Clinical Research Site Manager to join a dynamic, forward-thinking clinical trial site leading the charge in innovative health research. In this pivotal role, you'll oversee high-impact studies from startup to closeout, guiding teams and managing every detail to ensure world-class execution. If you thrive in a fast-paced environment and want to directly shape the future of clinical trials, this is your moment. What You'll Do: Lead and mentor a high-performing clinical study team Coordinate all trial activities-start-up, vendor management, patient visits, regulatory compliance Ensure GCP, FDA, ICH, and HIPAA compliance across every touchpoint Roll up your sleeves in screening, consenting, data entry, and lab procedures Collaborate closely with site leaders and investigators to deliver seamless operations Help drive continuous process improvements and quality initiatives What You Bring: Proven experience managing clinical trials (site-level experience preferred) Strong knowledge of GCP, ICH, and FDA regulations Hands-on approach to leadership and study coordination Passion for improving patient outcomes through research Be part of something bold. Join a team where your expertise matters-and where your impact will be felt every day. Apply now to step into a role where clinical excellence meets meaningful purpose.

Role: Clinical Project Manager Duration: 12 months We're seeking a Clinical Project Manager with a "sponsor mindset"—someone who drives a CRO to deliver. The ideal candidate has recent sponsor-side project management experience, with prior CRO-side exposure. What You’ll Do: Lead full study lifecycle, from vendor selection to closeout Manage CRO/vendor relationships and performance metrics Coordinate internal functions (data, safety, contracts, supplies, etc.) Ensure regulatory compliance and clinical documentation accuracy Manage clinical budgets and track invoices Own TMF and CTMS oversight What we are looking for: Therapeutic Areas: Oncology, Ophthalmology, Biologics Strong vendor oversight and clinical operations leadership Knowledge of GCP/ICH, regulatory submissions, and clinical risk management Experience overseeing timelines, budgets, CRO/vendor performance, and cross-functional study teams

Research Your Way to Succes - Advance your Career as a Research Administrator Are you ready to make a meaningful impact in a fast-paced, enterprise focused environment? UK HealthCare is seeking a Research Administrator to join our outstanding Sponsored Projects Administration at the University of Kentucky. This specialized area delivers exceptional research support services to internal clients within the UK Enterprise. Why Research Administrators Choose the University of Kentucky! The University is nationally ranked as one of the best colleges in the US. Top 10% of Hospitals Nationwide: Recognized as a leader in world-class care and fostering a positive work environment. Pediatric Level 1 Trauma Center. Forbes' Best Large Employers: Ranked among the Top 100 Employers Nationwide in 2024 and named one of Kentucky's Best Employers on Forbes' America's Best-In-State Employers list. Magnet Designation: Celebrated for Nursing Excellence and Innovation. Relocation Assistance: Up to $5,000, prorated based on mileage , for candidates relocating fifty miles or more. Competitive Pay & Flexible Shifts: $43,805.00 - $70,075.00 Monday through Friday, 8am to 5pm and additional hours as needed for position performance Your Role as a Research Administrator acting as the University of Kentucky administrative liaison for sponsor agencies and university faculty and staff review of sponsor proposal guidelines proposal review and identification and communication of issues with proposals and proposal budgets proposal submission to sponsor agency award review and negotiation with sponsors award acceptance and signature sponsored project account establishment interpretation and implementation of university policies and procedures interpretation of sponsor regulations and State law providing responsive and appropriate post-award administrative guidance to faculty, staff, and sponsor agencies and award records, documentation of completed processes, and preparing UK and PIs for audits. Requirements Education: Master's degree Experience: 1 year of related experience Preferred Prior University experience highly preferred Certified Research Administrator (CRA) preferred Licenses & Certifications: None required Additional Benefits 200 percent retirement match! Low-cost quality healthcare plan options! Further your education with our amazing tuition assistance benefit! Growth Opportunities: Advance your skills and career in a collaborative environment! Your Next Chapter: Lexington Awaits Lexington, KY, the "Horse Capital of the World," offers the charm of a small town with the amenities of a bustling city. Enjoy a vibrant downtown with diverse dining, arts, and entertainment, plus easy access to beautiful hiking trails, historic bourbon distilleries, and scenic landscapes. With affordable housing, excellent schools, and a welcoming community, Lexington provides an ideal environment for both career growth and quality living-perfect for those seeking a blend of adventure and tranquility in the beautiful Bluegrass region. Ready to Make a Difference? Join UKs Office of Sponsored Projects and step into a role where your skills, compassion, and dedication matter! Apply today!

Description: The Operating Room Clinical Specialist plays a vital role in supporting our field sales initiatives and external medical education efforts within the operating room environment. This position is part of the Medical Affairs team and focuses on KOL recruitment and development, while also enhancing peer-to-peer engagement. The Operating Room Clinical Specialist works either from a home office or a Kerecis office and reports directly to the Director of Medical Affairs. Essential Functions: Field Sales Support Provide clinical expertise and support to field sales teams within the operating room business unit Assist in training sales personnel on product knowledge, clinical applications, and evidence-based practices related to Kerecis products Conduct product demonstrations and educate healthcare professionals on the benefits and usage of our medical devices Customer Relationship Management Build and maintain strong relationships with key healthcare professionals and stakeholders in the operating room environment Understand their clinical needs, address challenges, and identify opportunities to enhance the adoption of Kerecis products Key Opinion Leader (KOL) Engagement and Development Recruit and cultivate relationships with KOLs and healthcare professionals to support external educational initiatives and clinical research programs Facilitate engagement through organized discussions, workshops, and research collaborations External Medical Education Lead the development and execution of external medical education programs, creating scientific materials, presentations, and training modules Provide clinical support at conferences and educational events, ensuring that healthcare professionals receive comprehensive information about Kerecis products and their applications Cross-functional Collaboration Collaborate with internal teams, including sales, marketing, and clinical affairs, to align and execute on medical education and engagement initiatives Foster cohesive communication and teamwork to support overall business goals Compliance and Regulatory Affairs Ensure that all activities comply with U.S. laws, regulations, and industry standards Assist in the preparation and submission of regulatory documents pertinent to medical education initiatives Data Analysis and Communication Demonstrate an aptitude for digesting clinical research and effectively communicate key insights to internal stakeholders and external partners Prepare reports and presentations that succinctly summarize important findings and implications for clinical practice Requirements: Education & Experience Bachelor's degree from an accredited college or university in life sciences, medical sciences, or a related field; advanced degree preferred Minimum of 5 years of experience in medical education or related roles within the biotechnology or medical device industry Competencies & Attributes Strong project management skills with the ability to deliver results on time Excellent communication and interpersonal skills for effective collaboration with various stakeholders Knowledge of medical device regulations, compliance requirements, and industry guidelines Familiarity with clinical research processes Proficiency in data analysis and scientific documentation Exceptional attention to detail and organizational capabilities Anticipated travel: 75-80% This job description is not intended to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this role. Duties and responsibilities may change at any time. Kerecis is an equal opportunity employer.

*Impact Living Services is hiring an Outpatient Regional Coordinator for our Roanoke location!* *Pay* *$65,000-$80,000* *Impact Living Services offers its employees:* * Competitive pay (based on qualifications) * Free CSAC Supervision and EMDR consultation * Training/certification Opportunities * Public service loan forgiveness (PSLF) eligible * 401k for Full-time Employees * Healthcare, vision and dental for Full-time Employees * PTO for Full-time Employees * Holiday pay *Job Responsibilities include:* *Administrative Duties:* * Provide supervision and oversight to 5-13 staff * Verifying clinical integrity and oversight of required documentation and checking compliance of counselors * Managing incoming outpatient referrals and disperse to outpatient staff * Help recruit and Interview applicants for outpatient positions * Onboard and ongoing training of new/current staff * Maintains readiness for external and internal audits. *Program Growth Duties:* * Explore new outpatient growth opportunities for your region * Grow referrals and community relationships for your region * Maintaining relationships with referral sources *Clinical Duties:* * Provide high quality billable outpatient therapy sessions up to 15 hours per week (may vary based on other required job duties) * Employs effective listening skills to establish rapport with individuals, groups, couples, and family member to provide emotional support and encouragement, and engage family members in the service process. * Initiates and provides ongoing communication with other service professionals to ensure coordination of care. * Documents case activities for all services and billing purposes. *Qualifications:* * Must possess a Master's Degree from an accredited college or university in a mental health related field such as Psychology, Counseling, or Social Work. * Must be Licensed by the Virginia Department of Health Professions (DHP). * Minimum of 5 years of direct clinical experience working with children/adolescents and adults who have been diagnosed with a mental illness. * Must have a valid Driver's license with an acceptable driving record. * Ability to pass all child protective services, criminal history and DMV background checks * Be a self-starter with good organizational and time management skills * Must have positive, hopeful and professional attitude *Experience:* * 5 years working with at-risk children and families with a mental health diagnosis (required) *Education:* * Master's (Required) *License:* * LMHP (Required) * LPC * LCSW * LMFT *Disclosure: Impact Living Services is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.* Job Type: Full-time Pay: $65,000.00 - $80,000.00 per year Benefits: * 401(k) * Dental insurance * Flexible schedule * Health insurance * Health savings account * Life insurance * Paid time off * Retirement plan * Vision insurance Schedule: * Monday to Friday Application Question(s): * Are you a Licensed Counselor or Social Worker? * Have you completed your supervision course to provide licensure supervision? Ability to Relocate: * Roanoke, VA 24012: Relocate before starting work (Required) Work Location: Hybrid remote in Roanoke, VA 24012

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing: * Serve as the primary point of contact between investigational sites and the sponsor * Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out * Ensure site compliance with ICH-GCP, SOPs, and regulations * Maintain up-to-date documentation in CTMS and eTMF systems * Support and track site staff training and maintain compliance records * Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting * Support subject recruitment and retention efforts at the site level * Oversee drug accountability and ensure proper storage, return, or destruction * Resolve data queries and drive timely, high-quality data entry * Document site progress and escalate risks or issues to the clinical team * Assist in tracking site budgets and ensuring timely site payments (as applicable) * Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: * A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN * Eligible to work in United States without visa sponsorship * A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry * Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology * Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF * A clear communicator, problem-solver, and collaborative team player * Willing and able to travel up to 50% for on-site monitoring visits across Midwest region (TN, MI, IN, IL, TX); preference given to candidates residing within these states to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

The UNC LCCC Cellular Therapy Program (************************************************** is seeking a study coordinator to facilitate complex investigational and FDA -approved cellular and gene therapies within according to federal regulations, Good Clinical Practice, and local and institutional policies. This position will ensure that patients who are being evaluated for and undergoing cell therapy receive comprehensive, coordinated care in an organized and high-quality manner. The study coordinator will work with a multi-disciplinary team of pre-clinical faculty, clinical faculty, and UNC Medical Center staff to design, develop and deliver investigational and/or FDA -approved cellular and gene therapies to adult and pediatric populations. This position will coordinate the conduct of early phase cellular and gene therapy clinical trials, including patient and data management. The coordinator will maintain the quality of research by addressing patient safety and regulatory compliance. Required Qualifications, Competencies, And Experience Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word. Knowledge of GCP and ICH Guidelines and ability to follow established regulations, procedures, and protocols. Previous study coordinator or patient navigation experience. High level of accuracy and attention to detail. Ability to plan work and coordinate multiple projects. Strong attention to detail and accuracy; excellent organization skills. Experience navigating medical records and data extraction. Preferred Qualifications, Competencies, And Experience Research Certification - SOCRA / ACRP Experience in early phase interventional clinical research Experience in oncology Work Schedule Monday - Friday, 8:00am - 5:00pm

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is currently seeking a Consumer Study Coordinator at our Glen Allen, VA location. Our Glen Allen location focuses on consumer opinion studies related to nicotine and tobacco products. This position will work 30-40 hours per week and is eligible for benefits. We are looking for someone who has the flexibility to work between the hours of 8:00am-6:30pm Monday-Friday, with the possibility of the occasional Saturday. As a Consumer Study Coordinator, you will be responsible for the preparation and maintenance of all stages of participant activities, including screening, training, and evaluations. Primarily, this is a customer service-based role, developing positive participant communications and relationships. Other duties include entering and updating study information into computer systems, and collecting and organizing panelists' paperwork and documentation. Requirements: We are seeking candidates with at least two years of customer service experience, administrative skills and the ability to work a flexible schedule. Consumer/market research experience is preferred. Ability to work in the required work environment, including but not limited to exposure to secondhand smoke from combustible cigarettes and vapors from electronic cigarettes on a daily basis. According to the Code of Virginia 18.2-371.2B, employees must be 21 years of age to work around tobacco products. $19 - $19 an hour Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Job DescriptionDescription: ROLE THE CLINICAL RESEARCH ASSISTANT (CRA) IS A SPECIALIZED RESEARCH PROFESSIONAL WORKING WITH AND UNDER THE DIRECTION SITE DIRECTOR AND CLINICAL PRINCIPAL INVESTIGATOR (PI). WHILE THE PRINCIPAL INVESTIGATOR IS PRIMARILY RESPONSIBLE FOR THE OVERALL DESIGN, CONDUCT, AND MANAGEMENT OF THE CLINICAL TRIAL, THE CRA SUPPORTS, FACILITATES AND COORDINATES THE DAILY CLINICAL TRIAL ACTIVITIES AND PLAYS A CRITICAL ROLE IN THE CONDUCT OF THE STUDY. BY PERFORMING THESE DUTIES, THE CRA WORKS WITH THE PI, RESEARCH TEAM, AND SPONSOR TO SUPPORT THE ADMINISTRATION OF THE COMPLIANCE, FINANCIAL, PERSONNEL AND OTHER RELATED ASPECTS OF THE CLINICAL STUDY. RESPONSIBILITIES The CRA's primary responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI and sponsor to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study. oordinates with PI and the CRC to help ensure that clinical research and related activities are performed in accordance with federal regulations, site-specific policies and procedures, and sponsor required policies and procedures. Maintains effective and ongoing communication with the sponsor, research participants, CRC, and PI during the course of the study. Works with the PI and CRC to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management. Reviews and comprehends the protocol, investigator brochures (when applicable), and all study-related manuals/guidelines. Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. Prepares other study materials as requested by the PI and CRC. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Prepares study-related documentation, including but not limited to source documents, adverse event reports, and progress notes. Establishes and organizes study files, including but not limited to study-specific source documentation and other materials. Attends investigator meetings as required or requested by the PI. Assists PI and CRC in communicating study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members—documents date of training and signatures of study personnel trained on the study-specific training log. Works with the PI and the CRC to develop and implement recruitment strategies in accordance with IRB requirements and approvals. Conducts or participates in the informed consent process, including interactions and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Conducts or assist the PI or CRC with procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures. Conducts or assist the PI or CRC with screening subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Coordinates participant tests and procedures. Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Collects data as required by the protocol. Assures timely completion of Case Report Forms. Maintains study timelines. Assist the CRC or maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Clinical Trials Center of Middle Tennessee, LLC SOP on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains and maintains all study records, including but not limited to case report forms, drug dispensation records, or regulatory forms in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures. Coordinates appropriate and timely payments to participants (if applicable) in accordance with Clinical Trials Center of Middle Tennessee, LLC policies and procedures. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem-solving efforts such as protocol revisions. Coordinates and facilitates monitoring and auditing visits. Collaborates with PI and institution to respond to audit findings and implement approved recommendations. A great CRA possesses excellent verbal and written communication skills. Ensure Participant Understanding: When communicating with participants, the CRA should be able to explain a complex research protocol at the patient's level of understanding TOOLS FOR SUCCESS The Anatomy of a Great Clinical Research Coordinator ************************************************************************************ Requirements:

Responsibilities Clinical Research Assistant (CRA) provides support to the research team by collecting, entering, abstracting, and managing the study data for sponsor data systems, publication, or other reporting. The CRA may also assist the Clinical Research Nurse (CRN) and/or Clinical Research Coordinator (CRC) in the set-up and execution of clinical research protocol procedures and associated administrative responsibilities. In some cases, the CRA may coordinate retrospective, quality, and other non-therapeutic research trials under Principal Investigator direction. Additionally, the CRA is responsible to maintain research medical equipment; accurately maintain logs; perform protocol-related tasks as assigned (within scope of practice); inventory, store, order and maintain study-related equipment/ supplies. Qualifications Required: * One year in a research or healthcare setting Desired: * One year in data entry or abstraction * Associate Degree * Certified Clinical Data Manager OR Certified Clinical Research Associate OR Certified Clinical Research Coordinator OR Certified Clinical Research Professional OR Certified Medical Assistant OR Certified Tumor Registrar

Clinical Research Assistant Benefits of working at VCU All full-time university staff are eligible for VCU's robust benefits package that includes: comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefit, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more. Learn more about VCU's benefits here. Job Code 34001 Recruitment Pool All Applicants Posting Number req6537 Unit VP Research MBU Department IDAS Department Website Link idas.vcu.edu Location VCU Address 907 Floyd Ave, Richmond, VA 23284 USA Duties & Responsibilities VCU Institute for Drug and Alcohol Studies At VCU, we are UNCOMMON and UNLIKE any other university. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It's a place of opportunity where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work. VCU's Office of the Vice President for Research and Innovation and the Institute for Drug and Alcohol Studies (IDAS) invites all interested candidates to apply for our exciting Clinical Research Assistant position! IDAS advances multidisciplinary research and training on the neuroscience of addictions and related neurobehavioral disorders. VCU is UNLIKE the rest. Our impact is measured one student and patient at a time.VCU's unequaled combination of excellence, diversity, research and creativity makes success possible for every one of our 300,000+ “RAMily” members. And that makes us one of the most innovative universities in the country. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It's a place of opportunity, where your success is supported and your career can thrive. All full-time staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more. Explore our benefits further here: ********************************************** Position Primary Purpose and General Duties The VCU Institute for Drug and Alcohol Studies (IDAS) advances multidisciplinary research and training on the neuroscience of addictions and related neurobehavioral disorders. Research Assistants perform a variety of routine, non-technical duties in assisting technical and professional personnel in a research laboratory setting. The Research Assistant will be expected to perform most components of data collection from human-subject volunteers required for a biomedical behavioral research study. Qualifications Minimum Qualifications VCU supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment. Bachelors of Science degree or equivalent in Psychology, Neuroscience or related field or equivalent experience. Proficient in computer skills including word processing, data entry, spreadsheet, database management, and entry level statistical/programming skills required. Strong clinical skills, including fundamental clinical skills such as establishing rapport, maintaining participant motivation, empathic responding, ability to work effectively as part of a multidisciplinary team, and ability to use clinical judgment in (rare) emergency situations. Strong organizational skills, including understanding of HIPAA regulations. Ability to organize meetings, and present reports. Preferred Qualifications Masters degree or equivalent in Psychology, Neuroscience or related field Writing experience with first author and co-author peer reviewed manuscripts Knowledge of statistical analysis and software applications Experience recruiting, consenting, and carrying out study procedures with opioid use disorder (OUD) treatment participants, including during pregnancy and postpartum Qualitative research experience, including data collection, coding, analysis Ability to set up projects and surveys in REDCap, perform sample size calculations using GPower 3.1, analyze qualitative data (such as with ATLAS.ti.8) and quantitative statistical analysis (such as with SAS 9.4 and GraphPad Prism). Experience with preparing and maintaining Institutional Review Board (IRB) and regulatory paperwork to comply with institutional regulatory requirements Experience in mentoring and training student research trainees, incorporating them into research teams Job Family: Research, University Title: Clinical Research Assistant, Job Code: 34001N FLSA University Employee Job FTE 100 Exemption Status Non-Exempt Restricted Position Yes E-Class UF - University Employee FT Job Category University Employee ORP Eligible No Salary Range Commensurate with Experience, Up to $45,000 Compensation Type Salaried Target Hire Date 11/18/2024 Contact Information for Candidates Brandon Seigel *************** Documents Needed to Apply

Assist in the collection and documentation of study activities and procedures. Maintain study areas and equipment in a tidy and operational state. Assist study team in conduct of research studies Essential Functions /principal accountabilities Performs competencies and job requirements as trained and delegated and as applicable to study protocols. Collects data according to protocol/clinic SOP' Performs all job responsibilities in accordance with standards of GCP (Good Clinical Practice), clinic SOPs, OSHA guidelines, Federal and local regulations Completes all required training programs per company requirements Honors password protections and confidentiality. Reports to Director/Manager/Coordinator of Clinical Services on all administrative, logistical and staff related site issues. Responsible to the Principal Investigator (PI) on all aspects of study conduct. Timely evaluation/sign-off of study documentation. Ensures Correct Procedures are performed in a timely manner on the correct participant according to Protocol requirements. Ensures study participants confidentiality and HIPAA compliance. As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor: Performs study procedures: Specimen Collection Phlebotomy Perform CLIA waived tests and specimen processing Vital signs, EKG's Height, weight, and BMI calculations Product Dispensing and Accountability Other procedures as trained and delegated Manages receipt, distribution, supervision, and documentation of study participant's meals Monitor bathrooms Preparation of Study Areas: Ensure study and participant areas are cleaned and maintained in a tidy and organized manner Ensure equipment is set up and ready for use Provides study scrubs and linens for study participants Provides other general assistance to the clinic team such as labeling of study supplies, study room arrangement and bed assignment Make calls to study participants to confirm study activities/restrictions/reminders Study Participant Recruitment Represent Facility in Community Events and Health Screening Programs Performance of and Management of Pre-Screening and Screening Procedures Preparation of study source binders Filing of source documents in a timely manner Complete source documentation accurately, legibly and in real time. Review source documents on an ongoing basis to ensure accuracy and completeness. Correct source documentation errors in a timely manner Report deviations or study related issues to supervisor Enforce clinic rules and regulations Search study participants personal belongings brought to the clinical research center for contraband Verification of Investigational Product and Concomitant Medication Administration Ensure study participants are available for procedures in a timely manner Educate study participants regarding study procedures being performed Assisting in the training of new staff members Assist other departments as needed

Job Details TN 8110 Walnut Run Road 0VQ48 - Cordova, TN High School None ResearchDescription Have you been looking for a place to grow your skillset? Or perhaps you are looking for a place to develop your career surrounded by a diverse group where employees feel a sense of belonging. At Gastro One We are championing the power of inclusivity and a people first mentality. We hope to improve the human experience - from our patients to our colleagues. If you are interested in joining our culture, we're looking for a Clinical Research Assistant. A little about us: Gastro One is a team of gastroenterologists and allied health professionals with a proven track record of providing excellent care that families can count on. We specialize in treating the full range of digestive diseases and endeavor to provide exceptional care, for every patient, every time. We are One GI , a true collaboration of the very best clinical and business minds - which enables us to focus on what's truly important - our patients. Snapshot of Daily Duties Prepare/conduct literature reviews. Collect and analyze data. Maintain accurate records of interviews, safeguarding the confidentiality of subjects. Summarize interviews. Provide ready access to all experimental data for the research coordinator. Request or acquire equipment or supplies necessary for the project. Prepare, maintain, and update website materials. Summarize project results. Prepare progress reports. Prepare other articles, reports, and presentations. The Must Haves High School Diploma or equivalent required. One (1) year of related research experience required. Comfortable performing experiments alone without close guidance or supervision. Desire to perform accurate and ethical research to achieve results for the study. Computer skills - good working knowledge of MS office. Ability to communicate effectively with others, both verbally and in writing. The Perks 401k with match Tuition reimbursement Competitive health & supplemental benefits Excellent paid time off for balance of work/life. Internal growth opportunities with training and development.

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Assistant at Wake Research, an M3 company. This is an on-site position at our Raleigh, NC site. The Clinical Research Assistant (RA) supports the daily execution of clinical trial activities under the guidance of site leadership, the Principal Investigator (PI), and the clinical research staff. While the PI oversees the conduct of the study and the Clinical Research Coordinator (CRC) manages its day-to-day operations, the RA plays a key supporting role in ensuring protocol compliance and data quality. Through collaborative efforts with the research team, the RA helps uphold the integrity of the study and prioritizes the safety and well-being of all study participants. Essential Duties and Responsibilities: Including, but not limited to the following: * Complete all required site and department training (GCP, IATA, OSHA, SOPs). * Maintain exam rooms and manage clinical supply inventory. * Ensure trial procedures follow ICH/GCP, federal regulations, site SOPs, and sponsor protocols. * Review study protocols and perform delegated tasks (vitals, ECGs, PFTs, phlebotomy, sample processing/shipment, EDC entry, eDiary reconciliation, safety follow-ups). * Manage regulatory documentation, lab area upkeep (temperature logs, centrifuge records, inventory), and resolve data queries. * Assist with participant screening, scheduling, visit preparation (charts, lab requisitions, kit assembly). * Accurately collect and document source data per protocol and GCP standards. * Support archiving of study documentation in compliance with regulatory and sponsor requirements. * Travel to peripheral/satellite sites to coordinate research activities and oversee visits. Qualifications * Associates degree or equivalent of clinical experience. * Medical assistant, EMT, Certified Pharmacy Technician, LPN/LVN, or Phlebotomist strongly preferred. * Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs is preferred. * Successful completion of the GCP certification. * Prior clinical research experience preferred. * Prior patient recruitment/community outreach experience preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: * 401(k), 401(k) matching * Dental insurance * Disability insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Vision insurance * M3 reserves the right to change this job description to meet the business needs of the organization #LI-LB1

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Assistant at Wake Research, an M3 company. This is an on-site position at our Raleigh, NC site. The Clinical Research Assistant (RA) supports the daily execution of clinical trial activities under the guidance of site leadership, the Principal Investigator (PI), and the clinical research staff. While the PI oversees the conduct of the study and the Clinical Research Coordinator (CRC) manages its day-to-day operations, the RA plays a key supporting role in ensuring protocol compliance and data quality. Through collaborative efforts with the research team, the RA helps uphold the integrity of the study and prioritizes the safety and well-being of all study participants. Essential Duties and Responsibilities: Including, but not limited to the following: Complete all required site and department training (GCP, IATA, OSHA, SOPs). Maintain exam rooms and manage clinical supply inventory. Ensure trial procedures follow ICH/GCP, federal regulations, site SOPs, and sponsor protocols. Review study protocols and perform delegated tasks (vitals, ECGs, PFTs, phlebotomy, sample processing/shipment, EDC entry, eDiary reconciliation, safety follow-ups). Manage regulatory documentation, lab area upkeep (temperature logs, centrifuge records, inventory), and resolve data queries. Assist with participant screening, scheduling, visit preparation (charts, lab requisitions, kit assembly). Accurately collect and document source data per protocol and GCP standards. Support archiving of study documentation in compliance with regulatory and sponsor requirements. Travel to peripheral/satellite sites to coordinate research activities and oversee visits. Qualifications Associates degree or equivalent of clinical experience. Medical assistant, EMT, Certified Pharmacy Technician, LPN/LVN, or Phlebotomist strongly preferred. Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs is preferred. Successful completion of the GCP certification. Prior clinical research experience preferred. Prior patient recruitment/community outreach experience preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

The job includes but is not limited to: screening patients for study eligibility, scheduling research visits/follow up, tracking/auditing consent forms and study related documents, preparation for both internal and external audits, collecting data and submitting to appropriate organizations, processing/packaging of lab specimens, maintaining inventory of research supplies, creating electronic research charts, scheduling site monitor visits and meeting rooms as needed and assisting in the implementation of new laboratory protocols and processes. . This is a fast- paced working environment involving time sensitive specimens and hard deadlines for data submissions. A high level of organization with attention to detail and the ability to manage multiple responsibilities is required. This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset. The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training, CITI training (including Good Clinical Practice (GCP), as well as become a member of the Children's Oncology Group (COG) research base. Required skills include ability to work with children, experience with computer data entry and statistical analyses, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE. Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting and following up on Serious Adverse Events. Coordinates the collection, processing, storage and/or shipping of clinical research specimens. Will be required to complete appropriate course to ensure compliance with the handling/shipping of specimens. Attends patient planning meetings, huddles, and webinars as assigned. Screens patients for study eligibility by attending meetings and utilizing the electronic health record EPIC. Develops strategies to ensure study subject compliance with protocol requirements. Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories and obtains results as needed. Performs clinical data gathering and measurements; maintains various databases to ensure accurate data is readily available. Assists in data analysis. Additional miscellaneous duties and responsibilities, as may be assigned from time to time by employee's supervisor.

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

The University of Virginia Neurology Department's Movement Disorders Clinic seeks a research assistant. The research assistant will work closely with the division's clinical neurologists, Principal Investigators, and the research and clinical teams in the conduct of research on movement disorders. The research assistant will work primarily on a research database tracking the progression of Parkinson's disease from which our neurologists will publish research. Largely, the research assistant will prepare for and assist with research visits, as well as recruit, schedule, consent, enroll and collect data from research patients. The research assistant will also assist with the preparation, validation, and analysis of study data. Availability to be present in our Movement Disorders Clinic at the UVA Primary Care Center (1221 Lee Street) on Mondays and Tuesdays is strongly preferred. Prior experience and preferred skills listed below are not required. Authorship on research publications is a possibility for some candidates. Responsibilities Work closely with Principal Investigator and other study team members on a clinical research database for the UVA Movement Disorders Clinic Recruit, screen, and enroll study participants who meet research criteria. Collect basic information through scripted interviews and answer general questions. Obtain informed consent from study participants and maintain telephone and in-person contact Collect and enter subject data, adhering to proper research protocols. Keep appropriate logs, track participants, schedule visits, and prepare study materials Assist with submissions of materials to the Institutional Review Board and department for approval Assist in ensuring integrity and completeness of collected data Assist in the preparation, validation, and analysis of data Assist in maintenance and development of REDCap research database Perform literature review as needed and assist in preparation of presentations Skills Microsoft office Chart review and navigating EPIC Electronic Health Record Familiarity with REDCap database environment Institutional Review Board submissions and reporting processes Patient-facing interaction and informed consent process Experience with statistical software (Stata, SAS, SPSS, R etc) Experience with literature review Federal Work Study eligibility is preferred but not required. Without FWS start date: ASAP With FWS start date: August 2025-May 2026 This position will require a Heath Screening. Pay commensurate with experience and scope of responsibilities ($20+/hr) MINIMUM REQUIREMENTS Education: Current undergrad or graduate UVA student Experience: None Licensure: None PHYSICAL DEMANDS This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs. The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Click here to read more about UVA's commitment to non-discrimination and equal opportunity employment.

Information Job Title Clinical Research Coordinator Department Internal Medicine - 31510 Pay Grade 7 Job Category Administrative Job Summary The Center of Excellence for Inflammation, ID, and Immunity is seeking applicants for a Clinical Research Coordinator. This position will support clinical research in the Clinical Research Office of ETSU's Center of Excellence for Inflammation, Infectious Diseases (CIIDI). Our Center has expanded in scope and has established a clinical core, with the addition of the Center of Excellence for HIV/ AIDS Care to the other scientific cores. The Clinical Research Coordinator will interface basic researchers and clinicians by facilitating specimen accrual to translational studies, particularly a new initiative with UTHSC focusing on genomic data merged with clinical data. The individual in this position will recruit subjects from studies, obtaining informed consent from subjects and clinical samples. This position will collect and/or process these samples for use and/or transport. The value of employment at ETSU goes far beyond salary. The official workday is 7.5 hours, which includes a one-hour lunch/meal break. Regular benefited ETSU employees enjoy a full range of benefits, services, and programs including: * Paid time off & leave * 17 paid holidays * Educational Assistance * Health and life insurance * Retirement * Access to University facilities and services and much more! Check out the ETSU Human Resources Benefits page for additional information at: *********************************************** ETSU is an equal opportunity employer. Disclaimer: The Job Summary is intended to describe the general nature and level of work individuals perform in this classification. It is not intended to be a complete list of all responsibilities, duties, and skills required. Management reserves the right to revise the job or require different tasks to be performed as assigned to reflect changes in the position. Employees must be able to perform the position's essential functions satisfactorily with or without reasonable accommodations. Knowledge, Skills and Abilities * Knowledge of good clinical practice, FDA, OHRP, and HIPAA policies. * Knowledge of research protocols, principles, and procedures. * Skills in phlebotomy as necessary. * Ability to demonstrate exceptional interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, and regulatory bodies. * Ability to effectively present information and respond to questions from physicians, staff, and patients. * Ability to handle multiple projects in parallel. * Ability to prioritize quickly and appropriately. * Ability to pay attention to detail. * Ability to demonstrate excellent organizational skills to independently manage workflow. * Ability to demonstrate excellent verbal and written communication skills. Required Qualifications * Bachelor's degree in Biological Sciences, Nursing, or a related health field * Minimum of one (1) year of experience in a clinical setting Preferred Qualifications * Phlebotomy experience and/or certification. Salary $38,080-$45,215 Posting Detail Information Posting Number AS01546P Is this position subject to a criminal background check? Yes Is any part of the funding for this posting coming from a grant or outside funding source? No FLSA Status Exempt Open Date 05/01/2025 Close Date Open Until Filled Yes Special Instructions to Applicants Administrative/Professional positions are only required to be posted for a minimum of fourteen (14) calendar days. The closing date for this posting is subject to change without notice to applicants.