Clinical research associate jobs in Warner Robins, GA

Scheduled Hours40The Cruchaga lab at the NeuroGenomics and Informatics Center is hiring a Senior Clinical Research Coordinator. This person will oversee and coordinate complex or multi-site clinical research studies, serve as a resource to provide comprehensive information to clinical research staff, promote smooth clinical operations, prepare regulatory compliance documents, coordinate interaction with other departments, and supervise clinical research coordinators and staff.Job Description Primary Duties & Responsibilities: Acts as the primary liaison to PI in developing plans for clinical research projects; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate. Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents. Designs, implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant's progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding. Assists in budget review and invoice tracking. Provides guidance and supervision to members of research team in the implementation and evaluation of clinical research; trains new staff; serve as lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance. Participate in the hiring, training, and evaluation of clinical research staff. Assists in scheduling and facilitating site visits by external and internal monitors and auditors. Provides study coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols; consents participants for non-therapeutic clinical trials and performs blood draws and other specimen collection as needed. Performs other duties incidental to the work described above. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: Bachelor's degree or combination of education and/or experience may substitute for minimum education. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Clinical Research (3 Years) Skills: Supervision Driver's License: A driver's license is not required for this position.More About This JobRequired Qualifications: Basic Life Support certification must be obtained within one month of hire date. Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement). Preferred Qualifications Education: Master's degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Clinical Research Management, Clinical Study Protocols, Communication, Computer Systems, Database Management, Data Entry, Detail-Oriented, Freezerworks (Software), Interpersonal Communication, Microsoft Office, Ordering Supplies, Organizing, Participant Recruiting, Phlebotomy, Research Projects, Research Support, Written CommunicationGradeC12Salary Range$62,000.00 - $96,100.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards Responsibilities Key Accountabilities Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution. Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle. Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies. Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records. Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly. Assist in managing study timelines, budgets, and deliverables, escalating risks. Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications. Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician) Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in life sciences or related field (Medical Technology, Biology.) Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR) Excellent understanding of clinical trial design Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrates strong regulatory knowledge to maintain compliance across global studies. Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution. Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes. Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment. Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines. Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure. Travel requirements: Will vary by project. Travel requirement could be approx. 20%

* About Us Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values ***************************************** make Augusta University an institution like no other. Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state. The University System of Georgia ******************************************************************************************* is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at ************************************************************************** Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at ************************************************ Location Augusta University Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912 Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904 College/Department Information Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet in order to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials; Community, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; Integrated and technology advanced IT systems to support efficient research processes. Job Summary The Research Associate conducts research responsibilities for assigned studies. Be familiar with study protocols, assist investigators with recruiting patient studies. Screen potential patients, help enroll and randomize patients with into studies. Collect and enter study data, prepare and maintain regulatory documents, resolve data queries. Schedule patient visits and procedures, perform or assist with venipuncture, prepare specimens for shipment. This position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). Responsibilities Responsibilities to include, but are not limited to: Coordination of clinical research trials to include meeting with drug and device company representatives, screening, recruiting and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing all laboratory and other tests as required by the protocol. Attend meetings, computer training, and workshops as requested. Keep investigator informed of patients' condition and provide assistance to investigators in the management of adverse events. Receive and respond to all correspondence received in a timely manner. Complete all reports including the annual study continuation report in a timely manner ' accurately communicate all necessary information to patients, families, investigators, sponsors, IRB, and institutional entities. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies as well as the Annual IRB Continuation Reports and other IRB activities as requested. Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs. Enter data into the OnCore research data management system as dictated per institutional policy as well as the Greenphire patient debit system. Review study bills received for accuracy ensuring that the correct codes are used and the correct amount is billed according to the billing grid for that study in a timely manner. Perform all other related duties as assigned. Required Qualifications Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research. OR Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience. Knowledge, Skills, & Abilities KNOWLEDGE Proficient in Microsoft Office and other computer software/databases. SKILLS Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong multi-tasking and prioritization. ABILITIES Ability to maintain confidentiality. Ability to recognize potential adverse events and follow SOPs for reporting of such. Ability to follow protocols as designed, remember protocols, and communicate with patients. Ability to adapt workflow to accommodate study amendments and principal investigator directions. Ability to work as a team player and adjust daily schedule in order to accommodate patient and investigator schedules. Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month. Ability to communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information. Must be able to communicate in non-abrasive manner. Shift/Salary/Benefits Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $45,400-$56,700 annually. Pay Band: B8 Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position. Recruitment Period: Until Filled. Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees. Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays. Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today! Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle. For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation. All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond. Other Information This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success." Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited. Equal Employment Opportunity Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans. How To Apply Consider applying with us today! ******************************** Search for Job ID: 288933. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university. Select University Faculty & Staff > Internal Applicants if you are a current university employee. If you need further assistance, please contact us at ************.

Description: Job purpose The Senior Clinical Research Associate will be responsible for leading study operational strategy and planning and overseeing the execution of clinical studies for the organization. 1. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCPs, Protocol and compliance and with study specific Monitoring Plan. Evaluates overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOP)/processes. 2. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject, as appropriate. Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject's safety and clinical data integrity at an investigator site such as Protocol issues. 3. Conducts Source Document Review of appropriate site source documents and medical records. 4. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. 5. Applies query resolution techniques and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. 6. Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. 7. Verifies site compliance with electronic data capture (EDC) requirements. 8. Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies IP has been dispensed and administered to subjects according to the Protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is released/returned. 9. Routinely reviews the Investigator Site File (ISF) for accuracy and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator site is aware of the requirements of archiving essential documents in accordance with local guidelines and regulations. 10. Documents activities via confirmation / follow-up letters, trip reports and other required project documents per SOPs, Monitoring Plan and Protocol. Supports subject recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. 11. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to adapt quickly, with the oversight of the Director, Clinical Research, to changing priorities to achieve goals / targets. 12. Acts as primary liaison with site personnel, or in collaboration with other department personnel. Ensures all assigned sites and project-specific team members are trained and compliant with applicable requirements. 13. Prepares for and attends Investigator Meetings and/or face-to-face meetings. Participates in Clinical department/project staff meetings, as needed. 14. Creates clinical project documents according to the Protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports. 15. Provides study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines. 16. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. 17. Assists with the training of newly hired Clinical Research Associates (CRAs). 18. Supports with the preparation of IRB applications, including Protocol and informed consents. 19. Other duties as required. Requirements: Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Must demonstrate good computer skills and be able to embrace new technologies. Excellent communication, presentation and interpersonal skills. Must have the functional and technical knowledge along with the skills to do the job at a high level of accomplishment. Possess ability to solve difficult problems with effective solutions. Takes a leadership role in developing monitoring organization characterized by process standardization, best practice sharing, and continuous improvement. Qualifications Bachelor's degree and 6 years as a Clinical Research Associate OR Associate's degree and 8 years as a Clinical Research Associate OR High School Graduate and/or technical degree and 10 years as a Clinical Research Associate. Prior participation in clinical projects as a Lead/Senior Monitor. Full working proficiency in English. Proficiency in MS Office applications. Ability to plan, multi-task and work in a dynamic team environment. Experience in more than one therapeutic area is advantageous. Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills. Clinical Research certification preferred, but not required. Working conditions Office Environment, Laboratory Environment.Able to travel up to 70% Physical requirements While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct reports Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.VIVEX Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job

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 into 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 ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in Dalton, Georgia * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & 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: ********************************

) Contract Duration: Through September 2026 Job Type: (30 hours/week, Monday-Friday during standard business hours) We are seeking a proactive and experienced Clinical Research Coordinator (CRC) to join our team in support of an ongoing vaccine clinical trial. This onsite, full-time contract role offers an opportunity to contribute meaningfully to research. The ideal candidate will be comfortable working independently and serving as a primary CRC for the study. As the trial progresses, additional responsibilities may be assigned, so flexibility and a collaborative mindset are essential. Key Responsibilities * Medical Record Review: Conduct comprehensive reviews of patient medical histories to support eligibility assessments. * Participant Screening: Perform phone screenings and prescreen potential participants for trial inclusion. * Scheduling & Coordination: Arrange in-person visits and follow-up appointments, and manage reminders to ensure participant compliance. * General Support: Assist with various study-related tasks as needed to ensure smooth trial operations. Work Environment * This role operates during standard business hours in a dynamic, fast-paced research setting. Job Type & Location This is a Contract position based out of Savannah, GA. Pay and Benefits The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Savannah,GA. Application Deadline This position is anticipated to close on Dec 23, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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 contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is 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-Onsite #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 contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is 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-Onsite #LI-LB1

Dialysis Clinic, Inc. is recruiting top talent interested in supporting our nonprofit mission to prioritize individualized care for patients facing chronic kidney disease. Our mission states “the care of the patient is our reason for existence,” and our dedicated team embodies our sole purpose during every patient interaction. We seek motivated, compassionate individuals to provide top-notch patient care and offer paid training, competitive pay, outstanding benefits, Sundays off and a strong culture. Join DCI today to build relationships and gain fulfillment serving individuals in our comfortable clinical setting with a lower caregiver-to-patient ratio than other providers. Clinical Research Coordinators provide support, coordination and leadership for drug/device studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials; government-funded clinical research, and investigator-initiated clinical research (collectively referred to as “clinical research involving human subjects”). They ensure smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure. They prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, schedule clinical treatment and follow-up care, and facilitate patient's continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents, and ensure compliance with study protocols in order to provide consistent and quality data. Provide superior healthcare utilizing medical knowledge and clinical skills throughout each clinical trial. Schedule: Full-time, typical schedule is five 8-hour shifts, Monday - Friday Compensation: Minimum salary starts at $45K with flexibility regarding starting salary based on experience and education Benefits: Comprehensive medical, dental and vision benefits Life and long-term care insurance provided at no additional expense to employee Paid time off (PTO) including holidays Extended Sick Bank (ESB) in addition to PTO - paid time for doctor appointments, sickness or medical leave Retirement plans with $.50 of each contributed dollar matched for eligible employees, up to 8 percent Education reimbursement Employee assistance program Wellness program Among others Responsibilities What You Can Expect: Ensure compliance with the clinical trial protocol and overall objectives of the study including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board (IRB) applications, CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture, etc.) as applicable. Perform detailed medical chart review and patient interview to ensure patient qualifies to be enrolled in the study. Manage informed consent process and ensure confidentiality practices are consistent with regulatory and study guidelines. Meet enrollment goals as directed by DCICR Director. Maintain a strong relationship with subjects involved in clinical trials and ensure that their rights as subjects are protected. Coordinate and perform study visits/procedures (vital signs, EKG's, BIA, medical history, lab procedures, etc.) per qualification and per protocol. Log and inform Principal Investigator (PI) of any possible adverse reactions or serious adverse events in a timely manner. Maintain study logs, IRB forms and Regulatory Binders for each clinical trial. Maintain a strong relationship with and be available to investigators and research, dialysis, and practice staff to ensure subject safety and compliance with the clinical trial protocol. Participate in routine monitoring visits from Sponsor and/or FDA audits. Conduct clinical trials in 2 or more outpatient dialysis units as needed. Coordinate multiple trials. Work flexible hours in order to accommodate study visits and perform job functions as needed. Travel overnight for Investigator Meetings as required. Work independently with limited supervision. Maintain and follow up with all research documentation and data involved in coordinating a clinical trial and/or multiple clinical trials in a timely manner to provide quality data and/or information. Other responsibilities as defined by DCICR Director and/or DCICR Clinical Manager. Qualifications Successful Candidates Bring: Excellent communication skills Demonstrated clinical excellence Desire to collaborate with care teams Ability to problem solve Education/Training: An individual with at least 2 years of experience conducting clinical trials or an individual currently employed in the medical field; dialysis experience preferred. Reliable transportation, a valid driver's license, auto insurance, and be willing to travel to multiple DCI clinics within a given territory. DCI is committed to building a diverse and inclusive organization. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status. DCI's Differentiator: Since opening the first clinic 50 years ago in Nashville, Tenn., our Dialysis Clinic, Inc. family has grown to be the nation's largest nonprofit dialysis provider with more than 270 locations in 30 states, serving nearly 14,000 patients each day. DCI invests in our care teams and funds research to further kidney care and treatment options. DCI prioritizes a holistic approach and offers hemodialysis, home dialysis and peritoneal dialysis treatment options. We empower patients to live meaningful and productive lives while also delivering high quality kidney care, saving lives and reducing hospitalizations. Learn more about DCI and see if we're hiring in a clinic near you! *************** DCI is a federal contractor and an Equal Opportunity/Affirmative Action Employer-Veterans/Individuals with Disabilities. If you are having difficulty using the online application system or would like to request other accommodations or application methods, please contact Doug Patterson at Accommodations@dciinc.org or ************. Once a request has been made, DCI will initiate a discussion with you about your needs and whether an accommodation can be provided. DCI is committed to providing such accommodations where possible. For more information about equal opportunity please see: ****************************************************************** ************************************************************************************************* *************************************************************** and ********************************************************************************************************** Security Roles and Responsibilities can be reviewed at: *************************************

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 contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: * Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. * Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. * Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. * Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. * Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. * Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. * In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. * Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. * Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. * Assists with timely completion of case report forms, if appropriately delegated/trained. * Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. * Assists fellow co-workers with studies as time and ability permits. Qualifications * Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. * Successful completion of the GCP certification. * Phlebotomy and EKG experience. * +2 years of CRC experience is 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-Onsite #LI-LB1

Optimize daily patient flow and operational efficiency while ensuring exceptional patient experiences across all clinic departments. Serve as the central coordination hub for scheduling, patient movement, real-time problem resolution, and team development support. Key Responsibilities Patient Flow Management Monitor and optimize patient scheduling to minimize wait times and maximize provider efficiency Coordinate patient movement between front desk, clinical areas, therapy, and checkout Manage walk-in appointments and emergency scheduling adjustments Track and report daily patient flow metrics and identify improvement opportunities System Coordination Serve as primary liaison between departments (clinical, therapy, imaging, front desk) Troubleshoot EHR system issues and coordinate with IT support Manage appointment modifications, cancellations, and rescheduling in real-time Ensure accurate patient information flow between all touchpoints Team Support & Training Coach front-line staff on operational procedures and patient engagement techniques Assist with new employee training and orientation processes Provide real-time feedback to team members on workflow efficiency and patient interaction quality Support ongoing staff development in clinic protocols and system utilization Share patient feedback and operational insights with team to celebrate successes and address improvements Patient Experience Address patient concerns and complaints promptly and professionally Communicate wait times and delays proactively to patients Ensure consistent service standards across all patient interactions Follow up on patient satisfaction issues and implement improvements Operational Support Assist with insurance verification and prior authorization coordination Support clinical staff with scheduling specialty appointments and follow-ups Maintain supply inventory awareness and coordinate with management Generate daily operational reports and productivity metrics Requirements 1-2 years healthcare experience, preferably in medical office or clinic setting Strong organizational and multitasking abilities Excellent communication and customer service skills Proficiency with EHR systems and scheduling software Problem-solving mindset with ability to work under pressure Natural mentoring abilities and patience for training others High school diploma required; healthcare certification preferred Success Metrics Patient wait time reduction Daily patient throughput targets Patient satisfaction scores Operational efficiency improvements Team performance and training completion rates Staff retention and development progress Why Join AICA? Be part of a dynamic and growing healthcare organization Work in a collaborative and supportive team environment Opportunity to develop leadership and training skills Clear path for growth in healthcare operations management Direct impact on both operational efficiency and team development Requirements 1-2 years healthcare experience, preferably in medical office or clinic setting Strong organizational and multitasking abilities Excellent communication and customer service skills Proficiency with EHR systems and scheduling software Problem-solving mindset with ability to work under pressure Natural mentoring abilities and patience for training others High school diploma required; healthcare certification preferred

Classification: Full time Non-Exempt Report to: Nursing Services Manager Summary/Objective: The Clinical Coordinator (RN) is responsible originating, developing, and managing employee staffing functions for the Medical-Surgical Unit and Emergency Room; supports staffing needs for the Medical-Surgical Unit and Emergency Department, within the scope of their license, as needed. This role is responsible for rendering nursing care in assigned area(s) in terms of individualized patient needs, according to dependent and independent nursing functions and conformance with recognized nursing techniques, procedures, and established standards based on the scope of nursing, under the direction/delegation of the nurse manager. Essential Functions: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. Generates monthly staffing schedules for Medical-Surgical unit and Emergency Room and posts in a timely manner. Input schedules into the online based schedule platform. Manages all vacancies, call-outs, and medical or other types of leaves of absences on a daily basis. (See the Nursing Services Manager for any FMLA request) Assists Nursing Services Manager to ensure Communication is fluent within the department and messages are pushed down to the front line staff from leadership. Assists the Nursing Services Manager or other nursing leaders in providing adequate nursing staff, including RNs, LPNs, & CNAs by aiding in setting up and conducting interviews and hiring nursing staff. Assists the Nursing Services Manager and assigned preceptor for orientation of new hires. (Getting their required documentation submitted to HR to get them access to the computer, Omnicel, Policy Tech, and CareLearning, and giving the new hire their competency packet and ensuring it gets completed in a timely manner) Ensuring the unit has appropriate supplies. Assists and facilitates, as appropriate, the communication and collaboration with nursing staff, patients, families, and other departments. Assisting with payroll every other Monday - with help from the manager and other nurse leaders. Accountability for time and attendance and tracking of those employees that are calling out so disciplinary action can be taken on them by the manger/director. Back up to the Nursing Services Manager during any absences or vacation time. Communication with the Nursing Agencies to help get shifts covered and verifying invoices. Submitting the check request for those companies. Helps follow up with staff on getting task completed and ensuring everyone has the communication information needed. Performs chart audits (for Med/Surg and ER), performance improvement initiatives, and other special projects as assigned by the manager and/or other nursing leaders, to include the CNO. Data collection and presentation for Emergency Department Committee meeting as well as for the QMS meeting monthly. Promotes compliance with accident prevention procedures, safety rules, and safe work practices to prevent employee injury and illness and control workers' compensation costs. Assist in departmental education opportunities and seek out opportunities for the Med/Surg and Emergency Departments. Within 1 year of hire, become an instructor for BLS, ACLS and possibly PALS. With in 1 year of hire, become the back up for the Emergency Management Coordinator. Assist with DNV and regulatory projects. Ensure daily logs are kept up to date. Assist with complaints and employee issues. Collaborate with Medical Records and Registration for ER chart corrections and charge verification. Take the lead for the kids ABC project. Assist with implementation and be a superuser for the electronic health record. Facilitate the education and requirements for the annual competency day. Follow up with staff and ensure they get their annual fit testing with employee health. Assist Nursing Services manager with annual evaluations. Ability to work in the clinical rotation of Medical-Surgical unit and/or Emergency Room, within the scope of a licensed practical nurse: Consults and coordinates with health care team members to assess, plan, implement, and evaluate patient care plans. Prepares, administers (orally, subcutaneously, through an IV), and records prescribed medications. Reports adverse reactions to medications or treatments in accordance with the policy regarding the administration of medications by a licensed practical nurse. Records patients' medical information and vital signs. Monitors and adjusts specialized equipment used on patients. Interprets and records electronic displays. Initiates corrective action whenever the patient displays adverse symptomatology. Provides beside care for a wide variety of medical patients, include pre- and post-surgery patients. Initiates patient education plan, as prescribed by physician. Teaches patients and significant others how to manage their illness/injury by explaining post-treatment home care needs. Changes dressings, inserts catheters, and starts IVs. Prepares equipment and aids physician during examination and treatment of patient. Responds to life-saving situations based upon nursing standards and protocols. Participates in discharge planning. Utilizes time management skills. Records all care information concisely, accurately, completely, in a timely manner, in the appropriate format, and on the appropriate forms. Answer and refer telephone calls or other inquiries to ensure accurate and timely communications. Cooperates with distribution of resources to maintain a therapeutic environment. Float among various clinical services, where qualified and competent. Competencies: Communication proficiency. Ethical Conduct. Leadership. Performance Management. Personal Effectiveness/Credibility Problem Solving/Analysis. Strategic Thinking. Technical Capacity. Supervisory Responsibility: This position has some supervisory responsibilities. Work Environment: This position operates in a health care setting. This role requires regular walking to various locations around the hospital. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and some mechanical equipment. The employee is exposed to a variety of patient conditions and elements. The noise level is moderate to quiet. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk, hear, and listen. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must frequently lift or move objects and patients weighing over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Position Type/Expected Hours of Work: This is a full time position. Days and hours of work are Monday through Friday; hours are flexible based on the job duties demand. Evening and weekend work may be required based on the needs of the position/job duties. This position requires administrative “on call” responsibilities to be rotated within nursing management team. When assigned as a staff nurse (due to a vacancy), this position may require shift work; shifts may vary, but working hours may be up to approximately 12 hours. Required Education and Experience: Current, valid certification in the state of Georgia a Registered Nurse. Current, valid AHA Healthcare Provider training (BCLS). Current, valid AHA Healthcare Provider training (ACLS). Preferred Education and Experience: Experience working as a practical nurse, including some medical/surgical experience. At Will Statement: Monroe County Hospital is considered at will. “At will” means that you may terminate employment at any time, with or without cause or advance notice. “At will” also means that Monroe County Hospital may terminate employment at any time, with or without cause or advance notice, as long as federal and state laws are not violated. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee of the job. Duties, responsibilities, and activities may change at any time with or without notice.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Compensation: $20-21/h Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Department: Operations Employment Type: Full Time Reporting To: Adrienne Hilliard Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key Responsibilities Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: * Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: * Assists with the basic screening of patients for study enrollment; * Assists with patient follow-up visits; * Documents in source clinic charts; * Enters data in EDC and answers queries; * Obtains vital signs and ECGs; * May perform blood draws; * Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; * Request and track medical record requests; * Enters data in EDC and answers queries; * Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and * Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; * Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. * Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; * Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and * Perform all other duties as requested or assigned. Skills, Knowledge and Expertise Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: * Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). * Must possess strong organizational skills and attention to detail. * Well-developed written and verbal communication skills. * Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. * Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. * Must be professional, respectful of others, self-motivated, and have a strong work ethic. * Must possess a high degree of integrity and dependability. * Ability to work under minimal supervision, identify problems and implement solutions. * Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits * Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. * Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly Rate: 19.00 -$21.00/hr (Depending on education, experience, and skillset) Schedule: 08:00 am - 4:30 PM - Monday - Friday Job Summary: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally in both English and Spanish. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.