Clinical research associate jobs in Johns Creek, 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: The list below may include all acceptable certifications and issuers. More than one credential or certification 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: No additional certification beyond what is stated in the Required Qualifications section. Work Experience: No additional work experience beyond what is stated in the Required Qualifications section. 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

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%

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.

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, ***************** Position Objective: To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality. Responsibilities: * Supports regulatory submissions to competent authorities. * May act as a site manager, and may provide site training. * Interacts with sites in accordance with local law, standards, and regulations. * Participates in vendor selection process. * Works with vendor on contracts. * Manages invoices. * Collaborates on core clinical documents. * Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders. * Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval. * Ensures maintenance of IRB/EC approval throughout the duration of the study. * Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary. * Assists with developing Health Care Provider (HCP) presentations. * May engage with cross functional teams. * Facilitates queries for all missing or inaccurate data. * Ensures that data changes are properly implemented and captured in the database or data system. * Assists in the evaluation and analysis of clinical trial data. * Disseminates publications to sites as necessary. * Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication. * Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents. * Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies. * Support ongoing Post-Market Surveillance and Quality Assurance activities * Ability to travel domestically and internationally up to 30% of the time. Qualifications: * Bachelor's degree in biological science, engineering, or another science-related field * Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience * Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies * Demonstrate project management, critical thinking, and communication skills * Proficient knowledge of medical terminology. * Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com. Position Objective: To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality. Responsibilities: Supports regulatory submissions to competent authorities. May act as a site manager, and may provide site training. Interacts with sites in accordance with local law, standards, and regulations. Participates in vendor selection process. Works with vendor on contracts. Manages invoices. Collaborates on core clinical documents. Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders. Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval. Ensures maintenance of IRB/EC approval throughout the duration of the study. Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary. Assists with developing Health Care Provider (HCP) presentations. May engage with cross functional teams. Facilitates queries for all missing or inaccurate data. Ensures that data changes are properly implemented and captured in the database or data system. Assists in the evaluation and analysis of clinical trial data. Disseminates publications to sites as necessary. Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication. Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents. Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies. Support ongoing Post-Market Surveillance and Quality Assurance activities Ability to travel domestically and internationally up to 30% of the time. Qualifications: Bachelor's degree in biological science, engineering, or another science-related field Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies Demonstrate project management, critical thinking, and communication skills Proficient knowledge of medical terminology. Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications

We currently have an exciting opportunity for a Research Coordinator to join our team! Benefits: Medical, dental, vision, short/long term disability, 401k, PTO, life insurance, critical illness, hospital indemnity, and holiday pay. Monday-Friday, 8AM - 5PM, no nights or weekends Duties may include but not limited to: Clinical Trial: Oversee all aspects of clinical trials, including patient recruitment, screening, and enrollment. Ensure that protocols are followed meticulously. Site Operations: Handle day-to-day site management, ensuring that all activities comply with regulatory requirements and study protocols. Data Management: Collect, verify, and manage clinical trial data, ensuring it is accurate and complete. Communication & Reporting: Act as the primary point of contact for study sponsors, participants, and other stakeholders. Provide regular updates and progress reports. Regulatory Compliance: Ensure all documentation, including regulatory submissions and patient records, are kept up-to-date and in compliance with ethical and legal standards. Problem Solving & Innovation: Identify areas for process improvement and implement solutions to drive efficiency and enhance trial operations. Requirements: Valid RN license in the state of practice Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or clinical research) Experience managing clinical trials, leading the enrollment for multiple clinical trials, developing a research program Clinical experience in cardiovascular medicine in any licensed role (i.e. RN, technologist, medical assistant, etc.) Strong organizational and time management skills Clinical research certification (e.g., CCRP) is a plus Knowledge of GCP, ICH guidelines, and regulatory requirements Heart and Vascular Care is a cardiology practice that places a priority on compassionate patient care and service. In our team-based and family-oriented setting, we strive to set a new bar for patient healthcare through a modern, friendly, and thoughtful approach. Come be a part of our growing team. Apply and someone will be in touch!

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: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. 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: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. 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. Overnight travel may be required for training and/or investigative meetings. 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.

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

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.

Job DescriptionClinic Coordinator - Patient Experience & Sales Are you a natural leader with a heart for people and a talent for communication? Do you thrive in a fast-paced environment where every interaction can make someone's day better? Are you passionate about health, wellness, and inspiring others to invest in their well-being? At The Joint Chiropractic, we believe leadership is not just about titles - it's about influence, service, and the ability to inspire excellence in others. As our Clinic Coordinator, you will work closely with leadership to ensure every patient feels seen, valued, and cared for - while helping guide and develop a high-performing front desk team that consistently delivers a beyond 5-star patient experience. This is a role for someone who doesn't just want a job - but wants to make an impact. You'll combine leadership, communication, and patient advocacy with sales expertise to help more people experience the benefits of chiropractic care, while partnering with management to build a motivated, engaged team culture that thrives on excellence. What You'll Do (in collaboration with leadership): Lead by example in delivering exceptional patient care, ensuring each visit is smooth, personalized, and uplifting. Assist in training, coaching, and motivating front desk team members so they're confident, capable, and committed to our mission. Help oversee daily clinic flow, anticipating needs, solving problems quickly, and ensuring operations run with precision and warmth. Build strong, lasting relationships with patients - remembering their stories, celebrating their progress, and helping them stay engaged in their care plans. Confidently present and recommend membership and wellness packages that align with patient goals, supporting both their health journey and clinic growth. Support the team in upholding The Joint's core values of Trust, Integrity, Excellence, Respect, and Accountability while contributing to a positive, professional atmosphere. Partner with the Clinic Director and Doctors to ensure our patient experience is consistently exceptional from check-in to checkout. Participate in marketing and community outreach efforts to bring new patients into the clinic. What We're Looking For: A people-first leader who naturally inspires trust, respect, and enthusiasm. Exceptional verbal and written communication skills - confident, clear, and warm in every interaction. At least one year of sales experience, preferably in a health, wellness, or service-based industry. Proven ability to work as part of a leadership team to motivate and guide others toward ambitious goals. Strong organizational skills with the ability to manage multiple priorities and maintain calm under pressure. A passion for health and wellness - chiropractic experience is a plus, but not required. Availability to work Saturdays as needed. Why You'll Love This Role: Competitive pay $15-$18/hr + Bonus Opportunities. Opportunities for growth and advancement within a rapidly expanding organization. A collaborative leadership role where you'll work alongside management to shape team performance and patient experience. The chance to help people live healthier, more active lives every single day. About The Joint Chiropractic The Joint Corp. revolutionized access to chiropractic care when it introduced its retail healthcare business model in 2010. Today, it is the nation's largest operator, manager and franchisor of chiropractic clinics through The Joint Chiropractic network. The company is making quality care convenient and affordable, while eliminating the need for insurance, for millions of patients seeking pain relief and ongoing wellness. With more than 700 locations nationwide and nearly 11 million patient visits annually, The Joint Chiropractic is a key leader in the chiropractic industry. Ranked number one on Forbes' 2022 America's Best Small Companies list, number three on Fortune's 100 Fastest-Growing Companies list and consistently named to Franchise Times “Top 400+ Franchises” and Entrepreneur's “Franchise 500 ” lists, The Joint Chiropractic is an innovative force, where healthcare meets retail. For more information, visit ***************** Business Structure The Joint Corp. is a franchisor of clinics and an operator of clinics in certain states. In Arkansas, California, Colorado, District of Columbia, Florida, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Washington, West Virginia and Wyoming, The Joint Corp. and its franchisees provide management services to affiliated professional chiropractic practices. You are applying to work with a franchisee of The Joint Corp. If hired, the franchisee will be your only employer. Franchisees are independent business owners who set own terms of employment, including wage and benefit programs, which can vary between franchisees. Powered by JazzHR 34bM8s01sW

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.

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, ***************** Position Objective: The Clinical Research Project Manager is responsible for the management of assigned departmental project tasks/systems identified below in support of aortic arch repair technologies. Responsibilities: * Liaison between Artivion, study sites, CROs, and other vendors (as applicable) to ensure study engagement and encourage transparent communication. * Management of clinical study sites to ensure that clinical trials are conducted in accordance with applicable standards and regulations. * Oversee project timelines, budgets, budget change forms, accruals, and monthly reports. * Support the development and amendment of the following documents: clinical protocol, study management plans, informed consent forms, case report forms, SOPs, etc. * Collect, query, analyze, and present clinical data and prepare internal and external study reports. * Conduct basic statistical analyses for technical support of product lines. * Conduct literature reviews and write research summaries related to product lines. * Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns. * Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence. * Evaluate and report on adverse events and complaints associated with the product lines. * Attend surgical congresses in person or remotely, as necessary. * Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature. * Support clinical strategy development for investigational device exemption (IDE) studies. * Participate in site recruitment/selection, investigator meetings, and site training. * Support the maintenance of any applicable clinical research databases as necessary. * Support the development of product Instructions for Use and assist with labeling and labeling changes. * Provide clinical support for marketing, regulatory, research and development, and quality departments. Qualifications: * Bachelor's degree in biological science, engineering, or another science-related field * Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience * Experience overseeing multicenter investigational (e.g. IDE) studies is highly desirable. * Experience with aortic disease is highly desirable. * Demonstrate project management, critical thinking, and communication skills * Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications

Scheduled Hours40The Cruchaga Lab, the NeuroGenomics and Informatics (NGI) Center, at WashU Medicine is recruiting a Clinical Research Study Assistant. We are seeking an experienced, self-motivated, self-driven person to work as a part of vibrant group in a fast-paced environment. This person will work in a collegial environment and join a multidisciplinary, diverse team in a well-established, well-funded research group, currently 30+ dynamic members, to explore the frontiers of neurodegenerative diseases. The NGI generates and analyzes Whole-Genome and high-throughput multi-dimensional omics data to study neurodegenerative diseases of the central nervous system. The goal of our research is to use genomic and multi-omic approaches to understand the biology neurodegenerative diseases. Under the direction of the Research Coordinators or PI, they will participate in moderately complex clinical research study activities. The Clinical Research Study Assistant will be responsible for multiple study's biospecimens including, but not limited to: blood, plasma, serum, and brain. They will perform a variety of duties including the oversight, organization and handling of these biospecimen samples for these multiple studies. They will ship samples and be responsible for an accurate manifest. They will be trained on the lab's database system to maintain the order of the samples. They will be responsible for assembling outgoing biospecimen kits for multiple studies. As needed, they will draw blood from research participants at our various clinics. They will work with the research coordinators for any other responsibilities that may be needed.Job Description Primary Duties & Responsibilities: Assists clinical research coordinators with management of clinical trials, by creating outgoing biospecimen kits for blood collection and recording data appropriately. Assists clinical research coordinators by receiving biospecimen samples from off-campus clinics, evaluating condition of samples, entering into the database, and reporting any issues to the coordinators. Assists with study sample tracking of home locations and shipping outgoing samples, as needed. Assists with general supply/equipment orders, material shipments to collaborators, maintenance and cleaning. Complies with established safety procedures and maintains required documentation on laboratory and specimen conditions. Working knowledge of computer programs and systems such as Excel and Word, as well as Filemaker Pro and/or Freezerworks. Assists current phlebotomists with blood drawing duties as needed. Assists with other duties as assigned by research team. 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: High school diploma or equivalent high school certification or combination of education and/or experience. 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: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job For more information about the NeuroGenomics and Informatics Center, please visit our website at this link. Required Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: Customer Service (1 Year) Skills: Clinical Trials, Data Entry, Data Management, FileMaker Pro, Freezerworks (Software), Interpersonal Communication, Oral Communications, Ordering Supplies, Organizing, Safety Protocols, Sample Collection, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe 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.

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: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). 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: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. 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.

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.