Clinical research coordinator jobs in Tallahassee, FL

Gastro Health, LLC is a leading medical group made up of physicians and advanced practitioners specializing in the treatment of gastrointestinal disorders, nutrition, and digestive health. Our research division provides patient access to Phase I-IV clinical research initiatives relational to Gastroenterology and Hepatology throughout the world. Our mission is to provide outstanding medical care and an exceptional healthcare experience. Gastro Health is built on our Core Values of Compassion, Collaboration, Integrity, Empowerment, Accountability, Continuous Improvement, and Positive Attitude. Job Summary: Due to our rapid growth, we are currently seeking an industry professional to join our research team. This vital role will work directly with subjects, under the direct supervision of the Principal Investigator (PI). This role will be responsible for performing and implementing all aspects of clinical research trials, ensuring protocol-specific and regulatory compliance. Responsibilities: Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits Ensure the safety and well-being of all study-related subjects throughout the course of their study participation Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy Assure IRB approvals are obtained prior to initiating any study-related activities Recruit and track subjects with expectations for target enrollment goals Current proficiency with conducting phlebotomy Consent subjects in accordance with FDA, GCP and protocol guidelines Ensure adequate understanding of inclusion and exclusion criteria for each protocol Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner Record all concomitant medications and medical/surgical history accurately for each subject Schedule all subject visits within study timelines identified within the protocols Ensure subject safety and communicate safety data in a timely manner with the PI Collect and accurately record study data in source documents and case report forms Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines Complete all paperwork as required by sponsor and CRA in a timely manner Why Work With Gastro Health? When you join Gastro Health, you become part of a team dedicated to supporting clinical research and discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing diseases. Gastro Health, LLC employs the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees, which includes: Health, Dental, Vision, Paid Time Off, Life insurance, 401k, Profit Sharing Plan, Short & Long-term disability, HSA, FSA and Corporate Holidays Qualifications: Bachelor's Degree, preferred Availability to travel as required for training sessions 3-5 years of Clinical Research experience required Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred Self-starter capable of working independently Ability to thrive in a fast-paced, high-pressure environment Desire to train and develop skills Exceptional written and oral communication skills BLS certification, preferred Familiarity with medical terminology Knowledge of how to operate/conduct and ECG/EKG Machine Skills in Phlebotomy/Venipuncture Ability to provide shadow support to entry-level research personnel Certification via SOCRA and/or ACRP Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)

Responsible for collecting, analyzing and interpreting collected data. The Research Associate 3 will adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes and ensure that the highest quality of research is performed. The estimated salary range for this position is $58494.88 - $76043.34 / year depending on experience. Degrees: * Masters Degree is required. Licenses & Certifications: * Collab Inst Training Init. Additional Qualifications: * CITI certification required within 30 days of hire. * While a Master's degree of Science is a minimum requirement, candidates with PhD and MD degrees (especially those who completed their residency programs) are preferred. * Candidates must be highly organized with strong analytical, research, math and statistical skills as well has had previous experience working in an academic and/or scientific setting. Minimum Required Experience: 5 Years

* 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 ************.

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Boca Raton, FL location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 7 AM - 3:30 PM (occasional weekends) Location: 7900 Glades Rd #400, Boca Raton, FL 33434 Compensation: $30-$36/hr + quarterly discretionary performance bonuses Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

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%

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%

Job Description 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 Additional Duties 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 How We Work Together Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Brandon, FL clinic. Travel: Regularly planned travel within the region will be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks 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: ********************************

About N-Power MedicineN-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster. Position OverviewYou will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Senior Digital Health Specialist, you will work at a clinical site in Tuscaloosa and/or Anniston, Alabama. This role would act as a site liaison between NPM staff and the network partner to address any issues or concerns in real time. The ideal candidate has extensive clinical oncology research experience or research experience in a healthcare setting. You are an expert in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. In collaboration with the Digital Health Specialist Manager, you will be vital to the successful implementation and operations with Network Partners and serve as point of contact for local N-Power Medicine staff. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer. Role Objectives and Responsibilities -Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.-Act as the point of contact for network partners and N-Power Medicine staff supporting the site to address queries and issues in a timely manner.-Participate directly in the implementation at the site and all aspects of a site start-up. -Support the hiring and onboarding of new N-Power Medicine staff including, new hire interviews, new hire training, onsite shadowing, etc.-Perform quality assurance activities as required, identify opportunities for retraining of Digital Health Staff.-Assist in developing training, work instructions and standard operating procedures, and other materials.-Manage queries regarding missing, aberrant, or potential outlier data for studies and projects - escalate to the healthcare provider and Digital Health staff as necessary for resolution.-Obtain informed consent for N-Power Medicine's clinical trials. -Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.-Ensure adherence to study protocols, data completeness and patient consent.-Lead patient recruitment strategies where appropriate as site liaison and network partner research department. -Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and N-Power Medicine.-Attend, participate and take action in required meetings.-Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.-Ensure quality and integrity of the Kaleido Registry and clinical trials data, protocol compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).-Collect practice insights regarding Kaleido Registry workflows and maintain site performance metrics for internal and site reporting. -Provide proactive input and user experiences including software- escalate issues while offering solutions based upon your expert knowledge and experience. -Solicit feedback from users of new technology and contribute to implementation for clinical care and clinical trials. -Additional duties and responsibilities as required. Education, Experience, Behavioral Competencies, & Skills-5+ years of experience in oncology clinical research and/or oncology ambulatory care -Bachelor's degree, focused in health science or related field -Clinical supervisory or management experience preferred-Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred-Bilingual in Spanish (or other language) is preferred-In depth knowledge of clinical trials, study-specific operating procedures and patient consent forms-Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives-Compassionate focused patient care-Coach and encourages other team members, contributing to a positive team environment-Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments-Results oriented focused on delivering the goals set-forth-Attention to detail and strong organizational skills-Exceptional oral and written communication skills with a proven ability to lead through effective interpersonal interactions at all organizational levels-Critical thinking and proven problem-solving skills-Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)-Generous, curious and humble. Travel Requirements Daily travel between network partner sites may be required Pay InformationThe expected salary range for this position is $118,000 and $177,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits. More About Us:We are a mission-driven, well-funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.” We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time. Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas. Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings. Notice on fraudulent job offers: Only positions posted on ****************************************** site are legitimate. Please be mindful of recruitment fraud and job scams. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Department The Office of Research and Anne's College are looking to fill the position of Clinical Research Coordinator, TOC. Responsibilities The Clinical Research Coordinator (CRC) will serve as an integral member of our research team and support the Director of Research at the Tallahassee Orthopedic Clinic (TOC). In addition, the CRC will work with and assist FSU researchers and FSU College of Medicine medical students collaborative research projects at TOC. This position will collaborate with physicians, faculty, staff, students, and other healthcare-related providers to perform a variety of tasks, such as screen and consent patients for research studies, develop and implement clinical research protocols, collect patient measurements (including range of motion, strength measurements, and other outcome data), collect and process clinical surveys and questionnaires, and other duties as assigned. The CRC should have a good working knowledge of musculoskeletal anatomy, prior knowledge of orthopedic injuries, and an understanding of basic orthopedic procedures to assist with the determination of study feasibility. Lastly, the CRC will assist in interpreting policies and procedures to members of the Health Care Team, patients, families, and visitors to ensure regulatory adherence and subject safety. Study Administration: * Assist the Director of Research at TOC and attending physicians in the development of research protocols, and facilitate initial study planning and execution of clinical trials * Coordinate Institutional Review Board (IRB) and Clinical Trials Compliance (CTC) requirements; assist with IRB submissions, monitor progress of studies and maintain regulatory & related documentation * Maintain strong understanding of Good Clinical Practice (GCP) procedures and HIPAA, Common Rule, and HITECH regulations * Develop, edit, and format budgets to meet CTC requirements, consent forms, brochures, advertisements, telephone scripts, and introductory questionnaires. Assist with posters & presentations. * Assist with participant recruitment and screening, identify prospective study subjects, conduct eligibility assessments, and obtain informed consent * Oversee scheduling and study logistics: coordinate study-related appointments, procedures, and follow-ups; administer calendars for research staff and participants * Prepare paperwork for divisional weekly and/or monthly conference meetings * Assign, conduct, and review internal research study audits * Assist with training new research staff and medical students on regulations for conducting research between FSU and TOC * Advise on methodology; facilitate data acquisition; and supervise analytical processes * Work with MS Word, Excel, image processing software, and other programs (e.g., Qualtrics, REDCap) Data Management: * Coordinate data management for listed protocols * Create and develop databases to store and organize patient data * Collect patient data related to clinical research protocols following established guidelines (HIPAA, IRB) * Collect patient measurements, including range of motion, strength measurements, and other outcome data * Collect and perform data entry and filing of patient information/data; accurately record and safeguard study data, and perform database maintenance and troubleshooting * Perform basic statistics, create graphs, create tables, spreadsheets, and other types of data visualizations Communication: * Correspond with sponsors, faculty, physicians, patients, clinical support staff, students and other collaborating programs, especially on multi-site/institutional trials, regarding such tasks as: * Inclusion/exclusion criteria * Protocol development and review * Documentation * Coordination of site visits * IRB status * Contracts and budgets * Investigator meetings * CFR's * Supplies and equipment needs * Purpose of studies, etc. Surveillance: * Create, collect, and process clinical surveys, assessments, and questionnaires * Make suggestions to the supervisor and facilitate policy changes as appropriate for the research division Other: * Maintain current knowledge of federal and state regulations regarding human subjects protections and the ethical conduct of research, including Office for Human * Research Protections, the Common Rule, Food & Drug Administration, Good Clinical Practices, Health Insurance Portability & Accountability Act (HIPAA), Health * Information Technology for Economic and Clinical Health (HITECH) and related requirements, as well as monitor, analyze, interpret and direct the dissemination of information about related developments and implications for the TOC clinical and health research community * Perform other duties as requested to ensure the timely completion of tasks necessary for the efficient operation of the FSU and TOC research collaborations Qualifications Bachelor's degree and two years experience or a combination of post high school education and experience equal to six years. Preferred Qualifications Education/Certificates * Master's degree in athletic training or related field * Athletic Trainer with BOC certification and FL license or license eligible * Degree in an allied health profession or related field Competencies/Experience * Knowledge and experience in orthopedics * Strong working knowledge of musculoskeletal system and basic orthopedic assessments * Demonstrated project management skills * Demonstrate ease with learning new programs * Communicate professionally with public in sensitive manner; screen requests and materials effectively and efficiently; and readily handle a variety of situations in a busy environment. * Work independently and as effective team member * Punctual; maintain excellent attendance record * Consistently demonstrate personal initiative * Display interest in the overall well-being of health system * Take initiative to assist whenever possible in the success of the institution * Maintain positive attitude and can work well with others, especially in complex situations Contact Info Cassidy Cooksey at **************** University Information One of the nation's elite research universities, Florida State University preserves, expands, and disseminates knowledge in the sciences, technology, arts, humanities, and professions, while embracing a philosophy of learning strongly rooted in the traditions of the liberal arts and critical thinking. Founded in 1851, Florida State University is the oldest continuous site of higher education in Florida. FSU is a community steeped in tradition that fosters research and encourages creativity. At FSU, there's the excitement of being part of a vibrant academic and professional community, surrounded by people whose ideas are shaping tomorrow's news! Learn more about our university and campuses. FSU Total Rewards FSU offers a robust Total Rewards package. Visit our website to learn more about our Compensation, Benefits, Wellness, Recognition, and Employee Development programs. Use our interactive tool to calculate Total Compensation options based on potential salary, benefits and retirement contributions, earned leave, and other employment-related perks. How To Apply If qualified and interested in a specific job opening as advertised, apply to Florida State University at ********************* If you are a current FSU employee, apply via my FSU > Self Service. Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume. Considerations This is an A&P position. This position requires successful completion of a criminal history background check. Equal Employment Opportunity FSU is an Equal Employment Opportunity Employer.

Job Description Manager, Study Coordination & Quality Control Join a team driven by science, powered by people, and committed to improving lives. A GLP public CRO is seeking an experienced and passionate Manager, Study Coordination & Quality Control, to lead its Preclinical Operations team. In this critical leadership role, you will oversee project execution, ensure quality excellence, and mentor a talented group of Study Coordinators and Quality Control Specialists. If you thrive in a collaborative, fast-paced environment and have a strong commitment to scientific rigor and operational precision, we'd love to meet you. About the Role As the Manager of Study Coordination & QC, you will guide day-to-day operations, champion quality excellence, and empower your team to deliver project outcomes that are on time, within budget, and compliant with all standards. Working closely with Study Directors, Project Managers, and other internal partners, you'll ensure seamless planning, execution, and reporting across preclinical studies. You will play an instrumental role in optimizing workflows, monitoring financial impact, enhancing cross-functional processes, and elevating the quality of deliverables. This is an opportunity to create meaningful impact-from shaping departmental procedures to supporting studies that advance scientific innovation. Key Responsibilities Team Leadership & Development Lead, mentor, and develop a high-performing team of Study Coordinators and QC staff. Provide daily work direction, coaching, performance feedback, and career development. Foster a diverse, collaborative, and trust-centered team environment. Operational Execution Oversee study coordination activities from project initiation through reporting. Collaborate with Project Managers, Study Directors, and internal stakeholders to support costing, scheduling, tracking, and reporting. Ensure all work is completed accurately, on time, and within budget. Maintain operational calendars and oversee Provantis data collection software usage and data extraction. Quality Oversight Monitor end-to-end process quality; develop and track quality metrics across operations. Review protocols, amendments, and reports for accuracy and compliance. Participate in pre-study and post-project evaluations, identifying opportunities for improvement. Strategic & Administrative Contributions Participate in departmental budgeting and workload projections. Identify staffing needs; support recruitment, hiring, and performance management. Develop and maintain SOPs to ensure alignment with current practices. Promote safety standards and uphold strong business ethics. Qualifications Bachelor's degree required. Minimum 5 years of study coordination and QC experience in a preclinical or related scientific environment. Ability to meet medical and safety requirements (including required vaccinations). Proven leadership skills, strong communication abilities, and a commitment to operational excellence. What We Value Our core values shape how we work and how we lead: Cultivating Human Connection We put people first and believe in the power of trust, inclusion, and courageous teamwork. Operating with Precise Execution We leverage data, remain agile, take ownership of results, and treat feedback as an opportunity to grow. Harnessing Relentless Curiosity We ask sharp questions, push scientific boundaries, and continuously innovate. Stewarding a Healthy Community We prioritize safety, sustainability, dignity, and equitable opportunities for employees, customers, and communities alike. Behavioral & Leadership Expectations Build and maintain a high-trust, high-performance team. Communicate clearly and with impact across diverse audiences. Coach and develop others, recognizing achievements and addressing challenges promptly. Plan effectively, stay organized, and consistently deliver operational excellence. Work Environment This role includes work in both office and laboratory settings and requires the use of PPE, completion of medical evaluations, and the ability to receive experimental vaccines as required. Ready to Make an Impact? If you are driven by purpose, inspired by scientific progress, and energized by leading teams toward excellence, we encourage you to apply.

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager. In this job you will: Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time. Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria. Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff. Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment. Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution. Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments. Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding. Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. Support the contract and budget negotiations and oversees Investigator/Site Payments. Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation. Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc. Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections. Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs). May be involved in the on-site training of additional staff as part of the SEO or other education programs. Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements. Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II. SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope. Qualifications Education Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects. Certifications Current Good Clinical Practice (GCP) International Air Transport Association (IATA) Current Basic Cardiopulmonary Resuscitation (CPR) Phlebotomy certification unless part of active professional licensure (RN or LPN) Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified. Additional Information Located in Coral Springs, Florida. (On-site position). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!

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

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!

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

Research Coordinator Reports to: Chief Medical Officer We are seeking a detail-oriented, highly organized Research Coordinator with broad medical knowledge to support and manage clinical research activities. The ideal candidate will play a pivotal role in the planning, implementation, and coordination of research studies. This position requires strong analytical skills, a working knowledge of medical terminology, and the ability to interact effectively with investigators, sponsors, and study participants. Key Responsibilities: Coordinate and oversee day-to-day operations of multiple research studies in compliance with study protocols and regulatory requirements. Screen, recruit, and consent study participants; ensure proper documentation and eligibility assessment. Meet with site managers and providers to explain study eligibility Collect, process, and manage clinical and research data accurately and in a timely manner. Maintain and organize essential regulatory documents, case report forms, and study files. Monitor study progress, perform regular audits, and ensure data integrity and protocol compliance. Act as a liaison between investigators and research staff. Coordinate study visits, procedures, and follow-up schedules for participants. Assist with writing reports, abstracts, and manuscripts for publication or presentation. Train new staff or students in research procedures and compliance standards. Qualifications: Required: Travel to Cahaba's rural clinics in Perry, Wilcox counties is required Based in-person in Centreville Broad Clinical knowledge required Ability to manage multiple priorities in a fast-paced environment. Strong organizational, interpersonal, and communication skills. Demonstrates a high level of initiative and independence in daily tasks Cahaba Medical Care is an Equal Opportunity Employer.

The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable. Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed. Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research. Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job. Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization. Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures. Regular and reliable attendance is required for the job.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

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