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  • Senior Clinical Research Coordinator - Plant City, Florida

    Denali Health 3.8company rating

    Clinical research coordinator job in Plant City, FL

    Denali Health is seeking an experienced Senior Clinical Research Coordinator to join our dynamic research team. The Senior Clinical Research Coordinator will be responsible for overseeing the planning, coordination, and execution of clinical trials at our research site. The ideal candidate will have substantial experience in clinical research, strong leadership skills, and a deep understanding of regulatory requirements and study protocols. Key Responsibilities: Study Coordination & Execution: Oversee the day-to-day execution of clinical trials, ensuring that protocols, maintaining and improving standard operating procedures (SOPs), and regulatory guidelines are adhered to. Serve as a point of contact between the study sponsor, PI, and research team. Coordinate the activities of the clinical research staff to ensure successful and timely completion of study milestones. Participant Management: Screen, enroll, and consent study participants in accordance with study protocols. Ensure study participants' safety and well-being by monitoring adherence to study protocols and identifying and addressing adverse events or protocol deviations. Data Collection & Documentation: Collect, record, and manage clinical research data with accuracy and completeness in accordance with Good Clinical Practice (GCP) and sponsor requirements. Maintain comprehensive and organized records, including study logs, patient files, and study source documents. Regulatory Compliance & Reporting: Prepare and submit required regulatory documents, including IRB submissions, FDA forms, and protocol amendments. Ensure all study documentation is up-to-date, compliant with applicable regulations, and audit-ready. Collaborate with study monitors, auditors, and other external reviewers to facilitate study reviews and inspections. Team Leadership & Training: Mentor and provide guidance to junior research coordinators and support staff, ensuring effective team performance. Train new staff on study-specific protocols, research regulations, and site SOPs. Communication & Collaboration: Liaise with study sponsors, vendors, and internal stakeholders to facilitate effective study management and communication. Lead study-related meetings, including study initiation, monitoring, and close-out visits. Qualifications: Education: Bachelor's degree in health sciences, nursing, or a related field. A Master's degree is p Minimum of 3 years of clinical research coordination experience. Experience in multiple therapeutic areas or complex clinical trials is an advantage. Certifications: Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred. Skills: Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial best practices. Strong leadership and project management skills. Excellent communication and interpersonal skills. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Why Join Denali Health? We offer a collaborative work environment focused on advancing clinical research and improving patient outcomes. Denali Health provides competitive compensation, career growth opportunities, and a culture dedicated to innovation and excellence. Apply now if you're ready to make a significant impact in clinical research and take on a leadership role.
    $63k-97k yearly est. 3d ago
  • Clinical Research Site Director - 248142

    Medix™ 4.5company rating

    Clinical research coordinator job in Maitland, FL

    We are hiring for a Clinical Research Site Director in the Orlando area. MUST have experience as a director at a site-level. Open to relocation candidates with the right experience. Clinical Site Director (Onsite Role) The Clinical Site Director is responsible for leading day-to-day operations at a clinical research center. This onsite position provides hands-on oversight to ensure that all clinical research activities are executed in alignment with ICH guidelines, GCP, FDA regulations, and internal policies. The role requires strong leadership, consistent presence at the site, and active management of research staff. Key Responsibilities Operational Leadership & Site Performance Provide comprehensive onsite leadership to drive site performance, operational efficiency, participant safety, and adherence to regulatory and protocol requirements. Oversee the daily functioning of the research site, ensuring staff coverage, quality standards, and smooth execution of study activities. Cross-Functional Collaboration Partner with internal teams across Business Development, Patient Recruitment, Finance, Budgets & Contracts, and Quality to align on expectations, maintain study timelines, meet enrollment goals, and deliver high-quality data to sponsors. Study Oversight & Data Quality Review performance dashboards and clinical trial systems to monitor patient flow, visit schedules, staff activity, and data updates. Ensure timely and accurate completion of all required study activities, documentation, and communications. Resource & Staff Management Lead allocation of site resources, monitor study team performance, and identify operational or quality risks. Manage, mentor, and evaluate research staff including coordinators and support personnel. Oversee interviewing, hiring, performance evaluations, coaching, training, disciplinary actions, and (as needed) terminations. Manage schedule approvals, payroll oversight, new hire onboarding, and ongoing staff development. Training & Compliance Facilitate initial and ongoing training on protocol requirements, CRF completion, SOPs, and operational guidelines. Ensure strict adherence to SOPs, GCP, FDA regulations, and internal quality standards. Identify compliance issues or process gaps and support the development and execution of corrective action plans. Investigator & Sponsor Support Collaborate closely with investigators to uphold participant safety and meet protocol expectations. Provide proactive risk mitigation strategies and support sponsor expectations throughout the study lifecycle. Administrative & Leadership Duties Participate in leadership, site, and sponsor meetings as needed. Perform additional duties as assigned to support the success of the research site. Skills, Knowledge & Expertise Minimum Qualifications Bachelor's degree and 5+ years of clinical research experience; an equivalent combination of education and experience may be considered. At least 2 years of supervisory or management experience, ideally within a clinical research site setting. Bilingual (English/Spanish) proficiency is preferred. Required Skills Strong organizational, time-management, problem-solving, and project management skills. Excellent written and verbal communication abilities. Strong interpersonal skills with the ability to work effectively with colleagues, participants, investigators, and external partners. Ability to manage multiple priorities and adapt to shifting demands. Professional demeanor with a high level of integrity, dependability, and initiative. Ability to work independently, identify operational issues, and implement solutions. Strict adherence to confidentiality standards, including HIPAA requirements.
    $71k-108k yearly est. 4d ago
  • Senior Clinical Research Coordinator

    Gastro Health 4.5company rating

    Clinical research coordinator job in Pensacola, 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)
    $64k-82k yearly est. 39d ago
  • Research Associate 3, Oncology Clinical Trials, FT, 8:00A - 4:30P

    Baptist Health South Florida 4.5company rating

    Clinical research coordinator job in Miami, FL

    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
    $58.5k-76k yearly 60d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in Atlanta, GA

    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
    $50k-80k yearly est. 60d+ ago
  • EVS Senior Coordinator- Orlando Health Watson Clinic Lakeland Highlands Hospital-Lakeland, FL

    Orlando Health 4.8company rating

    Clinical research coordinator job in Lakeland, FL

    The Environmental Services (EVS) Coordinator is responsible for assisting the supervisor with day-to-day operations, which includescheduling and training of staff, monitoring quality and operating all equipment as necessary. Position requires individual to train teammembers, monitor all essential functions for all current employees and, serve as a working lead covering positions in EnvironmentalServices. The position is responsible for executing the daily duties required to establish and maintain a safe, clean, healing environment development and monitoring EVS and procedures and contributes to department quality initiatives and programs serves as a member of the EVS Leadership team and assumes shift/operational responsibility in the absence of the supervisor. Opening Summer 2026 at 4000 Lakeland Highlands Road, Lakeland, FL. The Orlando Health System of Care includes award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities that span Florida's east to west coasts, Central Alabama and Puerto Rico. Collectively, our dedicated team members honor our over 100-year legacy by providing professional and compassionate care to the patients, families and communities we serve. Join us! Combining the collective strengths of two powerhouse organizations, Orlando Health and the high-quality physicians at Watson Clinic are expanding access to award-winning specialty care for patients in Polk County and beyond. Opening in summer 2026, Orlando Health Watson Clinic Lakeland Highlands Hospital - a state-of-the-art, seven-story, multi-specialty hospital - will serve as a vital 550,000 square-foot healthcare hub offering: 300+ inpatient beds and 69 emergency and observation beds 11 operating rooms and four cardiac interventional suites Dedicated labor and delivery services - including a neonatal intensive care unit (NICU) that will debut shortly after the hospital opens Comprehensive cardiovascular, neurology, and oncology services Advanced surgical procedures Join us in shaping the future of healthcare in Polk County as part of the Orlando Health Watson Clinic Lakeland Highlands Hospital opening team and share in the privilege of saying you were there from the very beginning. Benefits Beyond the Expected Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible, so that you can be present for your passions. "Orlando Health Is Your Best Place to Work" is not just something we say, it's our promise to you. Benefits that begin on Day 1 Four (4) weeks paid parental leave Debt-free degrees through our Preferred Education Program Tuition reimbursement and loan repayment programs Back-up childcare and elder care Fertility benefits and adoption assistance NCLEX reimbursement Free NCPDs for RN license Free Kaplan review courses Dedicated RN career counselor and GN Coordinators to develop you Specialty certifications reimbursement And more! Responsibilities Essential Functions • Conducts one-on-one training sessions using approved techniques, procedures, and educational materials in the training process. • Provides instruction to new hires and current employees in various areas. • Properly demonstrating technical skills, including steps cleaning process for patient & non-patient rooms, isolation rooms, critical care areas, ER trauma units, and ancillary areas including, but not limited to restrooms/bathrooms, public areas, corridors, and any other areas that may require attention. • Ability to respond to common inquiries or complaints from customers, using appropriate designated engagement techniques. • Maintains accurate floor care logs and checklists. • Able to mix chemicals according to instructions. • Recognizes the importance of how their communication is received by patients, visitors and other health care workers, staff, etc. • Recognizes their role as part of the larger organization and models the mission statement through interaction with patients, family, visitors, and other facility staff. Adheres to all Standards of Precaution, SDS and Hand Hygiene directives. • Must complete all mandatory training as designated and required. • Participates in departmental quality assurance and improvement activities as appropriate. • Must be able to maintain productivity and volume standards established for the assigned facility. • Keeps current with all policies and procedures of the hospital and the department. • Practices critical thinking skills to include prioritization of duties and immediate needs/requests (Stat cleans) • Identify and utilize appropriate resources to ensure identified problems or concerns are followed through • Demonstrate knowledge of facility safety requirements. • Demonstrates the ability to operate and properly maintain all EVS tools and equipment needed to clean and disinfect the environment. • Assists in onboarding new Environmental Services Technicians I, II, III and IV and V's as requested. • Cleaning duties include, but are not limited to patient bed, furniture, light fixtures, ceiling vents, windows, window • Instructs proper procedures for replenishing supplies as needed. • in the use of programs that include the hospitals bed management system. • Instructs in accomplishes these functions by pushing, pulling, cleaning carts, moving supplies and equipment, carrying buckets, operating equipment such as vacuum cleaners and wearing protective clothing as required by work environment or regulatory agency. • Provides comprehensive oversight of the shift • Provides new hires 60 Day evaluations and assist with annual competencies. • Interfaces with Supervisors, Office Coordinators, Ops. Managers and Director. • Proactively handles any improvement opportunities or concerns. Leads or participates in performance improvement projects and process improvement efforts. • Research, coordinates, and implements core training programs and systems (cleaning and disinfection practices, protocols, auditing tools, competencies, job aides, in-services, skills labs, etc.). • Develops and utilizes appropriate evaluation systems to measure effectiveness of educational activities and uses feedback to adjust programs accordingly. • Collaboratively selects training materials with department director and/or manager. • Maintains and organizes training materials and associated validation of employee competency training to meet accreditation requirements. • Establishes EVS annual continuing education calendar. • Completes training evaluations and critique reports for each individual trainee. Qualifications Education/Training • High School Diploma or GED Licensure/Certification • DOT (Department of Transportation) Certification • (CSCT) Certified Surgical Cleaning Technician • (CHEST Certification) Certified Healthcare Environmental Services Professional Experience Experience • Five (5) years health care environmental services experience • Analytical and oral communication skills. • Bed Management Systems Education/Training • High School Diploma or GED Licensure/Certification • DOT (Department of Transportation) Certification • (CSCT) Certified Surgical Cleaning Technician • (CHEST Certification) Certified Healthcare Environmental Services Professional Experience Experience • Five (5) years health care environmental services experience • Analytical and oral communication skills. • Bed Management Systems Essential Functions • Conducts one-on-one training sessions using approved techniques, procedures, and educational materials in the training process. • Provides instruction to new hires and current employees in various areas. • Properly demonstrating technical skills, including steps cleaning process for patient & non-patient rooms, isolation rooms, critical care areas, ER trauma units, and ancillary areas including, but not limited to restrooms/bathrooms, public areas, corridors, and any other areas that may require attention. • Ability to respond to common inquiries or complaints from customers, using appropriate designated engagement techniques. • Maintains accurate floor care logs and checklists. • Able to mix chemicals according to instructions. • Recognizes the importance of how their communication is received by patients, visitors and other health care workers, staff, etc. • Recognizes their role as part of the larger organization and models the mission statement through interaction with patients, family, visitors, and other facility staff. Adheres to all Standards of Precaution, SDS and Hand Hygiene directives. • Must complete all mandatory training as designated and required. • Participates in departmental quality assurance and improvement activities as appropriate. • Must be able to maintain productivity and volume standards established for the assigned facility. • Keeps current with all policies and procedures of the hospital and the department. • Practices critical thinking skills to include prioritization of duties and immediate needs/requests (Stat cleans) • Identify and utilize appropriate resources to ensure identified problems or concerns are followed through • Demonstrate knowledge of facility safety requirements. • Demonstrates the ability to operate and properly maintain all EVS tools and equipment needed to clean and disinfect the environment. • Assists in onboarding new Environmental Services Technicians I, II, III and IV and V's as requested. • Cleaning duties include, but are not limited to patient bed, furniture, light fixtures, ceiling vents, windows, window • Instructs proper procedures for replenishing supplies as needed. • in the use of programs that include the hospitals bed management system. • Instructs in accomplishes these functions by pushing, pulling, cleaning carts, moving supplies and equipment, carrying buckets, operating equipment such as vacuum cleaners and wearing protective clothing as required by work environment or regulatory agency. • Provides comprehensive oversight of the shift • Provides new hires 60 Day evaluations and assist with annual competencies. • Interfaces with Supervisors, Office Coordinators, Ops. Managers and Director. • Proactively handles any improvement opportunities or concerns. Leads or participates in performance improvement projects and process improvement efforts. • Research, coordinates, and implements core training programs and systems (cleaning and disinfection practices, protocols, auditing tools, competencies, job aides, in-services, skills labs, etc.). • Develops and utilizes appropriate evaluation systems to measure effectiveness of educational activities and uses feedback to adjust programs accordingly. • Collaboratively selects training materials with department director and/or manager. • Maintains and organizes training materials and associated validation of employee competency training to meet accreditation requirements. • Establishes EVS annual continuing education calendar. • Completes training evaluations and critique reports for each individual trainee.
    $54k-76k yearly est. Auto-Apply 11d ago
  • Research Coordinator (College of Medicine)

    Florida State University 4.6company rating

    Clinical research coordinator job in Tallahassee, FL

    Department Translational Behavioral Research | Center for Translational Behavioral Science Responsibilities This position will provide research support at the Center for Translational Behavioral Science (CTBS), GROWTH Research Lab, and Scale it Up Florida Program. Support the development of standard operating procedures, assist study investigators with the design and implementation of data capture systems and data management, oversee research participant recruitment, consent, enrollment and retention in active research projects with a focus on emerging adult health (e.g., substance use prevention and treatment, HIV prevention and treatment, mental health) assist investigators with internal and external project reporting requirements, and participate in community engagement and dissemination efforts. Tracking project timelines, tasks, and study benchmarks as well as attending and participating in project meetings. As part of participating in research studies, this position may also support quantitative and qualitative data collection, management, and analysis. Support regulatory activities associated with funded projects including initiation and monitoring of study regulatory agreements and research study protocol development and modifications. As part of the CTBS Research Development Core, this position will support the Center Assistant Director in development core operations and serve as liaison with center faculty to provide consultative support for grant submissions and regulatory components of research, as assigned. Support the implementation of evidence-based practice initiatives and support community-focused, motivational interview training. Supervision of Research Assistants helping with research recruitment, developing literature reviews, and other research tasks. Qualifications Bachelor's degree and two years of experience; or a high school diploma/equivalent and six years of experience. (Note: a combination of post high school education and experience equal to six years.) This position requires successful completion of the eSPEAR Certification or ability to obtain the certification within 6 months of hire. 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. This position is being advertised as open until filled. Equal Employment Opportunity FSU is an Equal Employment Opportunity Employer.
    $48k-68k yearly est. 8d ago
  • Clinical Research Associate II - Transplant and Transfusion

    Werfen

    Clinical research coordinator job in Norcross, GA

    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%
    $50k-80k yearly est. Auto-Apply 40d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research coordinator job in Brandon, FL

    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: ********************************
    $60k-90k yearly 58d ago
  • Clinical Event (C.N.A., RN, LPN) -1/15/2026 8:30am -11:30am & 1pm-4pm

    Morselife Health Systems

    Clinical research coordinator job in West Palm Beach, FL

    Job Description MORSELIFE HEALTH SYSTEM CLINICAL HIRING EVENT 1/15/2026. Sign On Bonuses: C.N.A $2000, LPN $2500, RN $4000 We are hosting an interview day for all Clinical positions for our West Palm Beach Campus. Please be sure to bring a resume! Who: MorseLife Health System is the premier organization in the area offering a full continuum of care ranging from Long-Term Care and Short-Term Rehab to Home Care, Assisted Living and Memory Care and Hospice and Palliative Care. Where: 4847 David S Mack Drive, West Palm Beach, FL 33417 When: Thursday 01/15/2026 at 8:30AM - 11:30AM AND 1:00 PM - 4:00 PM Available Positions: Calling all Registered Nurses, Certified Nursing Assistants, Licensed Practical Nurses, and much more! Job Types: Full-time, Part-time, Per Diem SUMMARY MorseLife Health System is the premier organization in the area offering a full continuum of care services for seniors. Imagine putting your skill and passion to work, bringing a greater quality of life to countless residents. Imagine being part of an industry-leading team in the fastest-growing sector of health care today - senior care. That's exactly the opportunity that awaits you in a nursing career with MorseLife. At the MorseLife Health Center, you will have the privilege to work with the residents of our 5 Star, Long Term Care, and Memory Care units or in our state-of-the-art, neighborhood-layout Short Term Rehabilitation facility. The Tradition of the Palm Beaches represents a unique vision in senior care. This luxury assisted living facility on the MorseLife campus combines comprehensive, senior-focused healthcare services with all the amenities of a full-service, resort-style retirement community. Where can you find the perfect combination of flexibility and stability in a growing industry at a Medicare-certified, 5-Star leader in senior-focused health care? You just did. As a CNA or HHA with MorseLife Home Care , you'll be front and center in our effort to bring quality, customer-focused care to patients across Palm Beach County. Qualifications: Skilled Nursing, Short Term Rehab, Long Term Care, Memory Care, Assisted Living, Hospice Care, Home Care, Medicare and Hospital Experience. For Home Health Aides: 0-6 months minimum experience. For Certified Nursing Assistants: 0-6 months minimum experience. For Licensed Practical Nurses: 6 months minimum experience. For Registered Nurses: 6 months minimum experience. For Home Care Employees: 1 year experience in Medicare. Active FL License and CPR certification required for all clinical positions. An opportunity with MorseLife is more than a career: It's a calling that challenges and rewards like few other experiences. We are the elite destination for talented health care professionals seeking to perform meaningful work that truly makes a difference. If you're passionate about your work and are excellent at what you do, discover your inner greatness at MorseLife Health System. Job Types: Full-time, Part-time, PRN, Per diem Benefits: 401(k) 401(k) matching Dental Insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Referral program Tuition reimbursement Vision insurance Medical Specialty: Geriatrics Home Health Hospice & Palliative Medicine Physical Setting: Clinic Long term care Nursing home Rehabilitation center Supplemental Pay: Differential pay Signing bonus License/Certification: Florida License for your discipline (RN, LPN, C.N.A) (Preferred) BLS Certification (Preferred) Work Location: In person Powered by JazzHR cx R9N9h4Ni
    $46k-71k yearly est. 6d ago
  • Clinical Research Coordinator - PRN/ Contractor

    Wake Research 3.7company rating

    Clinical research coordinator job in Sandy Springs, GA

    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
    $45k-66k yearly est. 15d ago
  • Clinical Research Coordinator - PRN/ Contractor

    M3 Usa 4.5company rating

    Clinical research coordinator job in Sandy Springs, GA

    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
    $45k-66k yearly est. 9h ago
  • Clinical Research Coordinator Fort Myers South FL

    U.S. Renal Care, Inc. 4.7company rating

    Clinical research coordinator job in Fort Myers, FL

    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.
    $44k-63k yearly est. 2d ago
  • Clinical Research Coordinator - PRN/ Contractor

    M3 Global Research 4.2company rating

    Clinical research coordinator job in Gay, GA

    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
    $49k-65k yearly est. 19d ago
  • Clinical Research Coordinator III

    Denali Health 3.8company rating

    Clinical research coordinator job in Stone Mountain, GA

    Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities. Position Summary The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators. Key Responsibilities Coordination of Clinical Trials: Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies. Study Management: Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders. Participant Coordination: Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants. Regulatory and Compliance Oversight: Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times. Data Management: Enter, review, and verify data in EDC systems and ensure timely query resolution. Team Coordination & Leadership: Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability. Communication & Reporting: Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes. Qualifications Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred). Minimum 3-5 years of experience in clinical research coordination. Strong understanding of GCP, ICH, and FDA regulations. Exceptional coordination, multitasking, and communication skills. Experience with EDC systems and clinical trial management software preferred. CCRC/CCRP certification a plus. Why Join Denali Health Work with a mission-driven team advancing clinical research accessibility. Competitive salary and comprehensive benefits package. Professional growth and leadership opportunities. Collaborative environment focused on innovation and patient care. To Apply: Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ******************** with the subject line “Clinical Research Coordinator III - Stone Mountain.”
    $45k-67k yearly est. 23h ago
  • Travel Clinical Research Coordinator

    Care Access 4.3company rating

    Clinical research coordinator job in Orlando, FL

    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 Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact * Study Preparation: * Ability to understand and follow institutional SOPs * Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. * Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct * Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff * Assist with planning and creation of appropriate recruitment and marketing materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. * Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies * Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives * Assist in the creation or review of protocol specific source documents * Determine facility, equipment and outsource vendor requirements and availability * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance * Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks * Study Management: * Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. * Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies * Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records * Collect and evaluate concomitant medications * Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. * Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings * Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion * 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 * Strong and clear communication skills, both verbally and in writing * Accept accountability for actions and function independently * Patient Coordination: * Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment * Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial * Administer delegated study questionnaires, where appropriate. * Collect and evaluate medical records with the support of medically qualified members of the study team. * Complete visit procedures and ensure proper specimen collection, processing and shipment 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 * Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) * Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol * Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround * Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. * Monitor patient progress on study medication * Documentation: * Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP * Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. * Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart * Accurately transcribe data to CRF or EDC. * Resolve data management queries and correct source data as needed * Record protocol exemptions and deviations as appropriate with sponsor. * Complete Note(s)-to-File for patient chart and regulatory filing if necessary * Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing * Maintain copies of patient-specific correspondence in source charts * Assist regulatory personnel with completion of continuing/final review reports * Perform other duties as assigned. The Expertise Required * Excellent working knowledge of clinical trials, medicine and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ * 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. * Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. * 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: * BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred * RN or LPN preferred * Research Professional Certification- CRCC or exam eligibility preferred * A minimum of 3 to 4 years Clinical Research experience * A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together * Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study. The expected salary range for this role is $70,000-$100,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees Only) * 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: ********************************
    $70k-100k yearly 10d ago
  • Clinical Event (C.N.A., RN, LPN) -1/15/2026 8:30am -11:30am & 1pm-4pm

    Morselife Health Systems

    Clinical research coordinator job in West Palm Beach, FL

    MORSELIFE HEALTH SYSTEM CLINICAL HIRING EVENT 1/15/2026. Sign On Bonuses: C.N.A $2000, LPN $2500, RN $4000 We are hosting an interview day for all Clinical positions for our West Palm Beach Campus. Please be sure to bring a resume! Who: MorseLife Health System is the premier organization in the area offering a full continuum of care ranging from Long-Term Care and Short-Term Rehab to Home Care, Assisted Living and Memory Care and Hospice and Palliative Care. Where: 4847 David S Mack Drive, West Palm Beach, FL 33417 When: Thursday 01/15/2026 at 8:30AM - 11:30AM AND 1:00 PM - 4:00 PM Available Positions: Calling all Registered Nurses, Certified Nursing Assistants, Licensed Practical Nurses, and much more! Job Types: Full-time, Part-time, Per Diem SUMMARY MorseLife Health System is the premier organization in the area offering a full continuum of care services for seniors. Imagine putting your skill and passion to work, bringing a greater quality of life to countless residents. Imagine being part of an industry-leading team in the fastest-growing sector of health care today - senior care. That's exactly the opportunity that awaits you in a nursing career with MorseLife. At the MorseLife Health Center, you will have the privilege to work with the residents of our 5 Star, Long Term Care, and Memory Care units or in our state-of-the-art, neighborhood-layout Short Term Rehabilitation facility. The Tradition of the Palm Beaches represents a unique vision in senior care. This luxury assisted living facility on the MorseLife campus combines comprehensive, senior-focused healthcare services with all the amenities of a full-service, resort-style retirement community. Where can you find the perfect combination of flexibility and stability in a growing industry at a Medicare-certified, 5-Star leader in senior-focused health care? You just did. As a CNA or HHA with MorseLife Home Care , you'll be front and center in our effort to bring quality, customer-focused care to patients across Palm Beach County. Qualifications: Skilled Nursing, Short Term Rehab, Long Term Care, Memory Care, Assisted Living, Hospice Care, Home Care, Medicare and Hospital Experience. For Home Health Aides: 0-6 months minimum experience. For Certified Nursing Assistants: 0-6 months minimum experience. For Licensed Practical Nurses: 6 months minimum experience. For Registered Nurses: 6 months minimum experience. For Home Care Employees: 1 year experience in Medicare. Active FL License and CPR certification required for all clinical positions. An opportunity with MorseLife is more than a career: It's a calling that challenges and rewards like few other experiences. We are the elite destination for talented health care professionals seeking to perform meaningful work that truly makes a difference. If you're passionate about your work and are excellent at what you do, discover your inner greatness at MorseLife Health System. Job Types: Full-time, Part-time, PRN, Per diem Benefits: 401(k) 401(k) matching Dental Insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Referral program Tuition reimbursement Vision insurance Medical Specialty: Geriatrics Home Health Hospice & Palliative Medicine Physical Setting: Clinic Long term care Nursing home Rehabilitation center Supplemental Pay: Differential pay Signing bonus License/Certification: Florida License for your discipline (RN, LPN, C.N.A) (Preferred) BLS Certification (Preferred) Work Location: In person
    $46k-71k yearly est. Auto-Apply 5d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in Boston, GA

    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
    $52k-81k yearly est. 60d+ ago
  • Clinical Research Coordinator - PRN/ Contractor

    Wake Research 3.7company rating

    Clinical research coordinator job in Sandy Springs, GA

    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
    $45k-66k yearly est. 19d ago
  • Clinical Research Coordinator Fort Myers South FL

    Us Renal Care 4.7company rating

    Clinical research coordinator job in Fort Myers, FL

    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. Qualifications/Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements include: * Bachelor's degree in related field preferred. * One (1) to three (3) years of experience in clinical research required; nephrology experience preferred. * Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice. * Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus. * Strong verbal and written communication skills required. * Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
    $44k-63k yearly est. 11d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Valdosta, GA?

The average clinical research coordinator in Valdosta, GA earns between $36,000 and $75,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Valdosta, GA

$52,000
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