Clinical Research Associate Jobs in Port Charlotte, FL

We are looking to add a Site Manager to our growing team. This person would be responsible for overseeing 2 sites focused on Medical Device and Therapeutic clinical trials. This is a full time onsite role with lots of room for growth, fantastic benefits and the opportunity to join a large national organization that is changing the future of therapeutics. Job Description A Site Manager in clinical research plays a crucial role in overseeing and managing clinical trial sites within a specific geographic area. Their responsibility spans from site selection to ensuring that clinical studies are conducted in compliance with regulatory standards and study protocols. Responsibilities: Oversee and monitor the day-to-day operations of clinical trial sites in the region. Ensure that the sites adhere to protocol requirements, Good Clinical Practice (GCP), and regulatory guidelines. Provide support to sites during the initiation, monitoring, and close-out phases of the trial. Track and assess site performance, including enrollment rates, data quality, and adherence to study timelines. Troubleshoot issues related to recruitment, protocol deviations, and site performance. Provide feedback to the site team and implement corrective actions when necessary. Serve as the primary point of contact between the sponsor or Clinical Research Organization (CRO) and the clinical trial sites. Foster strong relationships with site staff, investigators, and other stakeholders. Conduct regular site visits and virtual meetings to ensure smooth communication and site support. Train site personnel on clinical trial protocols, data collection processes, and compliance procedures. Provide ongoing support to site staff to resolve operational issues or concerns. Ensure the timely submission of regulatory documents, including Institutional Review Board (IRB) submissions, informed consent forms, and other required paperwork. Ensure that essential study documentation is maintained accurately and in accordance with GCP and regulatory guidelines. Conduct routine site monitoring visits and assessments, ensuring sites are operating within protocol requirements. Prepare and submit regular progress reports to the Clinical Operations team or sponsor. Assist in resolving any issues that arise during monitoring visits and recommend solutions. Identify potential risks related to site management and proactively address issues to minimize study delays. Ensure that corrective actions are implemented at sites as needed. Qualifications Education: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Experience: Minimum of 3-5 years of experience in clinical research, particularly in site management or clinical operations. Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred. Skills: Strong understanding of clinical trial protocols, GCP, ICH guidelines, and regulatory requirements. Excellent communication, interpersonal, and organizational skills. Ability to manage multiple sites and tasks simultaneously. Ability to work independently with minimal supervision. Strong problem-solving and troubleshooting abilities. Preferred Qualifications: Experience in managing multi-site clinical trials Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.

Kelly Services is currently seeking a Clinical Metrology Associate for one of our top clients in Jacksonville, FL. Assist in building internal clinical metrology instrumentation to measure the impact of novel soft contact lens technology on vision and comfort. Essential functions: Deploy, maintain, and assess performance of clinical metrology instrumentation or methods 70 . Plan, conduct and document instrument qualifications according to internal procedures. Identify and map out internal procedures related to instrument qualification and document in workflow. c. Identify need of -and conduct- instrument calibrations. Assist in developing instrumentation and associated metrics under the supervision of clinicians and vision scientists 20 Monthly report out to stakeholders presentation, documentation Qualifications: Education: B.S. in Engineering or Science Minimum years of experience: 2 Required: Office Excel, Word . Preferred: Experience with statistics. Experience with optics. Experience with using and/or building scientific instruments. Experience with conducting clinical trials. Strong documentation skill Able to create work instructions / Aids Experience using and maintaining vision instrumentation Experience measuring and qualifying equipment Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Why Kelly ? The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions. Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage. The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs. As a Kelly Services employee, you will have access to numerous perks, including: Vacation and sick pay Paid holidays 401(k) plan Group medical, vision, dental, life, and short-term disability insurance options Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools Kelly Learning Center offers free courses and trainings Weekly pay About Kelly Services As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Highlights $60,000 - $70,000 salary + full benefits M - F schedule, no weekends or late nights! Tons of growth potential to Sr. CRC, Lead CRC, Site Manager, and more! The Company Our client is a fast growing clinical research site network that started in 2015 and grew to 11 sites with plans to double in the next couple years! They have run many clinical studies in Phase I - IV in therapeutic areas mainly focused in GI, Hepatology, and CNS! Their goal is to be the best place to work in the country, and they are excited to find people excited to make that vision come to life through quality patient care and research. Responsibilities As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process! Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans. Patient recruitment, enrollment, scheduling, and consent Lab procedures and shipments Maintain GCP and follow protocols Data management in EDC systems Overall coordination of the study Qualifications: 1+ years of experience working as a CRC on sponsor backed clinical trials Phlebotomy experience (ability to perform without supervision) Ability to work on site M-F on site (there is no remote or hybrid days)

Job DescriptionDescription Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute. Ensures processes are in place and roles are defined in order for studies to be conducted smoothly and compliantly, avoiding delays or errors with patient registration/enrollment and/or documentation and in accordance with protocol requirements. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Provides guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants and/or other support personnel. Job Specific Duties Serves as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies. Facilitates communication between investigators and Clinical Research Coordinators on subject-matter or technical matters. Oversees study conduct including all support data collection for study start-up activities. Oversees collection, maintenance, and reporting of accurate patient data for submissions to sponsors, maintaining patient records, and coordinating the collection and shipments of specimens as required by protocol. Reviews and confirms subject study eligibility with PI/Sub-I of assigned studies. Oversees study registration, patient screening/enrollment, and overall study requirements. Registers and enrolls research participants. Aggregates, tracks, trends, and reports research study and patient screening/enrollment data as required. Interacts with patients and families to recruit (screen, consent, and enroll) study subjects and ensures compliance with the protocol. Complies with the Research Finance Compliance policies and procedures including time and effort reporting for grants. Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization. Enters Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event. Pre-screens potential research participants and enters information into CTMS within real time (if possible) or within 24 hours. Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review. Updates study statuses in CTMS and ensures study enrollment changes are communicated to Research Regulatory Affairs team and CTO Management. Attends meetings with Research management, research team, and/or PI/Sub-Is and is prepared to discuss research portfolio and/or patient status. Qualifications Minimum Job Requirements Bachelor's degree or higher and 5 years of research experience (OR) 9 years of research experience Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position Knowledge, Skills, and Abilities Knowledge of rules and regulations governing the designated research. Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems. Bilingual in English/Spanish. Excellent communication skills in working with both children and adults. Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment. Experience with relevant hospital equipment for each clinical trial project. Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation). Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital. Ability to train, guide, and mentor peers. Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail. Ability to respond calmly under stressful conditions. Ability to maintain confidentiality of sensitive information. Ability to effectively work in a team. Excellent interpersonal skills. Excellent time management skills. Job : Research Department : RI - ADMINISTRATION-2100-380950 Job Status :Full Time

The Research Donor coordinator is responsible for the identification, approach, screening, and triage, of all necessary medical, behavioral, laboratory, and other data to ensure quality research recovery. The coordinator works closely with the Scientific Director and other research staff to coordinate tissue collection with research projects. All Research Donor Coordinators are dedicated to the highest ethical standards and are trained to ensure that tissue is recovered safely with respect and dignity to the donor and their family. All Research Coordinators must be good stewards of the donor's gift and to those who will receive this precious contribution for research. Essential Duties and Responsibilities Supports the Mission, Vision and Values of LWVI and exhibits a personal commitment to organ donation Supports the recovery and placement process for timely delivery of the highest quality research tissue for LWVI customers across potential recovery localities Performs donor medical history reviews and instructs recovery teams on handling, recovery, and shipment of donor tissue Telephonic approach of potential donor's next of kin for authorization to recover tissue for research purposes and, upon receipt of authorization, the completion of necessary referral and research donor paperwork Copies or obtains complete and accurate medical charts, behavioral data, laboratory data, blood specimens, and other pertinent data from the recovery site and other appropriate agencies Familiarity with Hospitals Policies in our service areas as well as Medical Examiner's Policies Familiarity with working relationship with Organ Procurement Organization Familiarity with Countrywide recovery staff and logistics to ensure timely recovery and shipment of potential tissue Performs EMR reviews as needed Interacts professionally and respectfully as a representative of LWVI with hospital, funeral home, and transplant/donation facilities Maintains patient and organizational confidentiality at all times. Conduct routine research laboratory functions including testing and validation, primary cell culture etc. Perform all job functions in accordance with applicable state and federal regulations, Eye Bank Associate of American Medical Standards, and LWVI SOPs Performs other projects and duties as assigned Education and Experience Bachelor's degree preferred; work experience in the fields of science and/or allied health care (Surgical Technician, Ophthalmic Technologists, EMT, ER Technician, etc.), background may substitute Knowledge of ocular anatomy, physiology and disease processes preferred Experience with donor approach for transplant and or research preferred Proficiency in iTransplant or similar donor referral software preferred Knowledge, Skills and Abilities Excellent oral and written communication skills with the ability to interact effectively with all Eye Bank, hospital and peer agency staff Knowledge of medical and ophthalmic terminology Basic research laboratory experience is preferred, though full training will be provided Be a self-starter and perform work independently Strong working knowledge of aseptic technique, applicable state and federal regulations, eye Bank Association of America Medical Standards, and LWVI standards operating procedures Must read and write English Must have reliable, dependable transportation to and from work. Effective interpersonal skills Strong organizational skills and detail-oriented Must be signed off by DSC for Screening purposes Ability to adapt to changing technology implemented to stay competitive Computer software skills, including but not limited to MS Outlook and Word Compensation and Benefits $21.00 - 23.70 per hour Paid time off with a starting maximum of 144.04 hours per year. 8 Company-paid Holidays per year. Medical, Dental, and Vision plan offerings for employees and their eligible dependents. All Vision plans 100% employer-paid. Employer-paid Employee Assistance Program, Life, Accidental Death & Dismemberment, Short-Term Disability, and Long-Term Disability plans. Offerings of Supplemental Life and Accidental Death & Dismemberment for employee and their eligible dependents. An employee may voluntarily designate a percentage of their salary towards employer-sponsored 401(k). LWVI will match the employee's contribution up to 6% of the employee's salary. Discounts on Pet Insurance and other items such as phone plans, movie tickets, etc. Schedule and Travel The position works at the LWVI offices in Tampa and does not require travel. Expected work shifts are Monday through Friday, 10 AM-7 PM (including a 30-minute lunch break) Work Environment The work is performed primarily in an office setting. The noise level in the work environment is moderate. The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related to a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change. As an equal opportunity employer, every qualified applicant will be considered for employment. Lions World Vision Institute does not discriminate based on race, color, sex/gender, political ideology, religion/creed, pregnancy, age, physical or mental disability, medical condition, genetic information, marital status, national origin, color, military or veteran's status, sexual orientation, gender identity, or any other status or characteristic protected by local, state, or federal laws. Lions World Vision Institute is committed to a diverse workforce and is also committed to a barrier-free employment process. In order to ensure reasonable accommodations with Title I of the Americans with Disabilities Act of 1990, individuals that require accommodations in the job application process for a posted position may contact us at ************** for assistance. Lions World Vision Institute will use E-Verify once you have accepted the job offer and completed the Form I-9.

A Clinical Trial Specialist provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principals. Responsibilities will include, but not limited to, study documentation maintenance, IRB submissions, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, accessioning, and inventory. **Job Responsibilities** + Successfully execute site onboarding process in an effective and timely manner + Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support. + Monitor and facilitate local site IRB and central IRB activities, including additional site submissions, amendments/changes in research submissions, create/facilitate submission of annual continuing review reports, monitor and notify of document expiration dates, and process fees through accounts payable. + Oversees creation of new study and site Trial Master File (TMF) entries, including site information and required documents. + Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol. + Maintains operational study documents; SOPs, Working Instructions, Lab Manuals, User Guides, and study specific forms that include tracking, preventative maintenance, instrument logs, quality assessments, reports and audits. + Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group. + Responsible for ensuring sample integrity and maintaining Good Clinical Practice (GCP) compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions. This includes, but not limited to, collecting requisite information, performing data entry for sample tracking/reporting, sample inventory, sample distribution and communicating status with key stakeholders (internal/external). + Oversees the shipment tracking, receipt, storage/inventory, maintenance and transfer/distribution of non-clinical samples and clinical study biospecimens. + Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under direction of manager. + Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment. + Enters specimen information into Sample Management System. + Reviews associated specimen submission documentation and verified accuracy of data entry. + Coordinates and assists in deidentification of specimen requests for purposes of research. **Required Qualifications** + Associate or higher degree with biological science coursework required. + Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook. + Candidates should have 1-2 years' experience in a Biorepository setting or Clinical Trial setting. + Experience in handling human biological materials + Demonstrates the ability to effectively and respectfully communicate with coworkers, staff, sponsors, and clients. + Continuously provides excellent customer service in an efficient and effective manner. + Excellent organization and time management/prioritization skills with the ability to both independently and with specific direction on a diverse and demanding workload + Attention to detail and problem-solving skills. + Ability to multi-task and work in a fast-paced, deadline driven environment. + Results oriented, hyper focused on service, quality, and continuous improvement. + Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification. **Preferred Qualifications** + Candidates should have previous experience in a Biorepository setting or Clinical Trial setting. + Candidates should have experience with clinical trial regulatory documentation or TMF. + Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment. + Laboratory Information Management System or Sample Management System experience preferred. + Customer service experience is preferred. + Good Clinical Practice training, IATA training, and Human Subject Protection training preferred. **Physical Demands** + Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time. + Ability to lift up to 30 lbs. **Training** + Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training. + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + This position requires some evenings, weekends and/or holidays. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.

Full-time Description CAN Community Health is the nation's premier resource in ending epidemics with a mission of empowering wellness, has an exciting opportunity for a Clinical Research Coordinator in our Sarasota, FL clinic. We are looking for someone who is passionate about serving the needs of individuals impacted by HIV, Hepatitis C, STI's, and other infectious diseases. You will become part of our professional team that drives home our Company's Mission and Values. We offer a good quality of life with an excellent daytime schedule, competitive pay with a bonus plan, premiere benefits package with a retirement plan with a generous company matching contribution. We have received recognition in 2025, 2024, 2023, 2022, 2021, 2019, & 2018 NPT's Best Non-Profit to Work for Award. CAN is a Drug-Free Workplace. All potential hires will be required to take and clear a pre-employment drug screen upon job offer. You can find out more about us by visiting our website at *************************** Apply Today! Statement of Purpose: The Clinical Research Coordinator (CRC) supports, facilitates, and coordinates the daily clinical trial activities under the direction of the Principal Investigator (PI). The CRC coordinates to support and complete the administration of the compliance, financial, personnel and other related aspects of the clinical study. Ensures that the best interests of all participants and the researchers are protected. Essential Functions: Coordinates with the PI, and the Director of Clinical Research (DCR); collaborating agencies, administration, and departments to help ensure that the clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures. Collaborates with the PI and DCR to develop materials and tools necessary to appropriately train study participants in the conduct of the study around issues of protocol requirements, schedule of visits, and compliance. Ensures training is completed and documented according to all requirements Assists PI and DCR in the communication of study requirements and training compliance to all team members involved in conducting the study. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Assesses, records and reports symptoms, reactions, treatments, and changes in clinical trial participant conditions. Performs EKG's, Venipunctures, Injections, infusions, and other procedures as required by the clinical research project. Register participants in the appropriate coordinating center and billing matrix as required. Coordinate participants tests and procedures. Collects data as required by the protocol. Maintains adequate inventory of study supplies. Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate venue. Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. Coordinates and facilitates monitoring and auditing visits. Documents and reports all required information and submits all study materials according to policies and procedures set by the sponsoring agencies and company protocol. Establishes and organizes study files including regulatory binders, study specific source documentation and other materials. Assists the PI and DCR in study feasibility assessments as requested. Attends Clinical Research meetings as required or requested by the DCR. Prepares all study materials as requested by the PI including but not limited to informed consent documents, case report forms, enrollment logs, and drug/device accountability logs. Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research and adheres to all legal standards of professional practice. 20. Demonstrates courtesy, compassion, and respect in all interpersonal and intra-professional relationships with CAN clients, staff, visitors, and partners. 21. Promotes and practices CAN Community Health Inc's mission and values and follows its policies and procedures. 22. Ensures confidentiality is maintained by entire team regarding patient/client information in accordance with HIPAA, professional and departmental standards. 23. Assisting nearby CAN clinics that are participating in trials. 24. Maintain all Investigator site files, including licenses, CV, and training certificates. 25. Submission of necessary documents to the IRB (initial applications, continuing review, deviations, communications etc.). Secondary Tasks: Triage patient phone calls and walk-ins and prioritizes emergencies for medical referral. Performs medical intake procedures including labs, vital signs and history. Participates in continuous quality improvement of services rendered to CAN clients. Develops and fosters networking relationships with community and support resources. Education/Professional: RN or BSN preferred, or minimum of a bachelor's degree, Life Sciences or in a health-related field. CPR Certified Experience: Minimum 3- years' experience directly related to the duties and responsibilities specified. Requirements Competencies: Leadership Strategic Thinking/Problem Solving Results Driven Communication Interpersonal Skills Decision Making Computer literate, ability to learn and utilize computer software programs. Knowledge, Skills and Abilities Required: Ability to work with minimal supervision. Ability to research projects. Excellent people manager, open to direction, suggestions, and commitment to get the job done. Delegates responsibility effectively. High comfort working in a diverse environment. CAN Required Trainings: Bloodborne Pathogen Annual Training Hazardous Drug Disposal Training Stericycle DOT Training Biohazard Waste Training HIPAA HIV/AIDS CITI Training (GCP, IATA) Compliance in Research Training Sexual Harassment Violence in the Workplace Health Stream Courses (as assigned) Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, audio visual, telephones, photocopiers, filing cabinets and fax machines. Physical Requirements: Neat, professional appearance. Sedentary- Exerts up to 25 lbs. of force occasionally and/or a negligible amount of force frequently or constantly in lift, carry, push, pull, or otherwise move objects. Involves sitting most of the time but may involve walking or standing for brief periods of time. Requires expressing or exchanging ideas by means of spoken word, visual and auditory acuity. Position Type/Expected Hours of Work: This position may require additional time above normal operating hours and on occasion weekend work. Travel: Travel is primary during the business day, although some out-of-area and overnight travel may be expected. Must be able to operate a motor vehicle and have valid insurance and driver's license. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Responsible To: Director of Clinical Research & Chief Medical Officer Must be able to pass a Level I and Level II background check. CAN Community Health, Inc. is an equal opportunity employer that is committed to diversity and values the ways in which we are different. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.

Bilingual Clinical Research Coordinator II-Neurology (MUST be Bilingual in English & Spanish) Shift: Onsite Monday-Friday 8:00 am-4:30 pm Qualifications (Must Have): Bilingual-English & Spanish Neurology theraputic experience AND one of the below Bachelor's degree in Healthcare Administration, Research, or related field and1 year of experience OR Associates degree in Healthcare Administration, Research, or related field and 2 years of experience OR Graduate of an accredited allied health certificate program with four years of clinical research or healthcare experience Bilingual Clinical Research Coordinator II-Neurology (MUST be Bilingual in English & Spanish) Recruit, screen, and assess eligibility of patients for research studies, trials, and programs. Coordinate patient care, follow-up, and bio-specimen collection (blood, tissue) with clinical staff and labs. Execute and manage informed consent processes across multiple locations, requiring travel or technology use. Ensure regulatory and protocol compliance through collaboration with clinical research staff and departments. Provide concierge-level service for patient interactions during clinical trials. Maintain HIPAA-protected databases linking patient info to bio-specimens; perform chart reviews and data collection. Assist in developing compliant research protocols and control documents. Serve as the point of contact for participants, investigators, and research staff. Implement SOPs for the research division and ensure compliance with clinical research standards. Conserve hospital resources while managing project budgets from various funding sources. Pay and Benefits The pay range for this position is $65000.00 - $65000.00/yr. Benefits from Day One Paid Days Off from Day One Career Development Whole Person Wellbeing Resources Mental Health Resources and Support Workplace Type This is a fully onsite position in Orlando,FL. Application Deadline This position is anticipated to close on Apr 25, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Pay Range: supports Florida Oncology & Hematology in Fort. Myers, FL. Why choose Florida Oncology & Hematology and American Oncology Network? • Shift: Monday- Friday, 8a-5p shift, NO nights, NO weekends, NO major holidays! • Competitive pay & generous PTO package, plus 6 paid Holidays and 2 "Floater" Holidays. • Comprehensive Benefits • Tuition Reimbursement • 401K Matching • AON's WellBeing Program Job Description Summary Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires. Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently. Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs. Review and interpret diagnostic test results and related documentation required per protocol. Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events. Dispense study medication in a professional and accountable manner following protocol requirements. Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens. Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised. KPA 2 - Regulatory and Data Integrity Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests. Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership. KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. Position Qualifications/Requirements Education High school education required. ASN or BSN required. Certifications/Licenses Registered Nurse. Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required. Previous Experience 2-5 years nursing experience required, oncology preferred. Core Capabilities Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. #AONN Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred. Prior experience with clinical trial data entry systems (EDC) preferred. Prior Clinical Trial Management Systems (CTMS) preferred. Travel: 0% Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM

Pay Range: supports Florida Oncology & Hematology in Fort. Myers, FL. Why choose Florida Oncology & Hematology and American Oncology Network? • Shift: Monday- Friday, 8a-5p shift, NO nights, NO weekends, NO major holidays! • Competitive pay & generous PTO package, plus 6 paid Holidays and 2 "Floater" Holidays. • Comprehensive Benefits • Tuition Reimbursement • 401K Matching • AON's WellBeing Program Job Description Summary Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires. Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently. Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs. Review and interpret diagnostic test results and related documentation required per protocol. Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events. Dispense study medication in a professional and accountable manner following protocol requirements. Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens. Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised. KPA 2 - Regulatory and Data Integrity Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests. Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership. KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. Position Qualifications/Requirements Education High school education required. ASN or BSN required. Certifications/Licenses Registered Nurse. Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required. Previous Experience 2-5 years nursing experience required, oncology preferred. Core Capabilities Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. #AONN Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred. Prior experience with clinical trial data entry systems (EDC) preferred. Prior Clinical Trial Management Systems (CTMS) preferred. Travel: 0% Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM

div name="main"div class="cl HeadSecondary"h2Job Details/h2/divdiv aria-label="Job Details" class="row" name="local_row"div class="col-md-6 local-tax-col local-ee" id="job DetailsLeftColumn" name="local_left"div class="row form RowStandard" id="Job Location-row" div class="form Line"div aria-label="Job Location" name="Job Location"span aria-label="Job Location" class="" name="level"Bradenton - Bradenton, FL/span/div/div/div/divdiv class="col-md-6 local-tax-col local-client" name="local_right"/div/divdiv class="cl HeadSecondary"h2Clinical Research Coordinator II/h2/divdiv aria-label="Clinical Research Coordinator II" class="row" name="description" style="word-wrap: break-word;"div class="row form RowStandard" id="job Desc-row" div class="form Line"span class="fb Text ignore-global-css" name="job Desc"pThe strong CRC II/strong will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis./p pbr/ strong DUTIES amp; RESPONSIBILITIES/strong/p ul li Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis./li li Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: ul lia. Sponsor-provided and IRB-approved Protocol Training/li lib. All relevant Protocol Amendments Training/li lic. Any study-specific Manuals Training, as applicable/li lid. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training./li /ul /li li Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner./li li Adherence to ALCOA-C Standards with all the relevant clinical trial documentation./li li Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations./li li Demonstration of appropriate and timely follow-up on the action items, at their respective sites./li li Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols./li li Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols./li li Demonstrating adherence and compliance to the assigned protocols at their respective site(s)./li li Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)/li li Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s)./li li Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)/li li Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s)./li li Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines./li li Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations./li li Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s)./li li Being prepared for and available at all required company meetings./li li Submitting required administrative paperwork per company timelines./li li Occasionally attending out-of-town Investigator Meetings/li li Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives/li li Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent/li li Facilitate effective communication between patients, healthcare providers, and research staff/li li2Any other matters as assigned by management./li /ul pbr/ strong KNOWLEDGE amp; EXPERIENCE/strongbr/ /p pstrong Education:/strong/p ul li High School Diploma or equivalent required; Bachelor's degree preferred/li li Foreign Medical Graduates preferred/li /ul pstrong Experience:/strong/p ul li At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting./li /ul pstrong Credentials:/strong/p ul li ACRP or equivalent certification is preferred/li /ul pstrong Knowledge and Skills:/strong/p ul li Be an energetic, go-getter who is detail-oriented and can multi-task./li li Be goals-driven while continuously maintaining quality./li li Proficient communication and comprehension skills both verbal and written in the English language are required./li li Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred./li /ul p /p /span/div/div/divdiv aria-label="" class="row" name="qualifications" style="word-wrap: break-word;"div class="row form RowStandard" id="job Qualifications-row" div class="form Line"span class="fb Text ignore-global-css" name="job Qualifications"/span/div/div/div/div

Vitalief is a leading site solutions partner focused on improving the value and contribution of clinical trial sites across the drug development lifecycle. With deep expertise in Consulting (strategic and operational) and Functional Service Provider (FSP) services, we provide fully integrated solutions that streamline clinical trials, improve patient outcomes, and drive value for Sponsors, CROs, and sites. We are seeking a talented and enthusiastic Clinical Research Coordinator (CRC) to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our client with a high priority, ongoing oncology clinical study within specific geographic regions. WHY VITALIEF? You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better. Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: Market competitive - based on experience level. Work Location: 100% onsite in Tampa, FL. Responsibilities: Under the direction of a PI, the CRC will be responsible for identifying patients (utilizing EPIC) screening patients for eligibility for a variety of ongoing oncology clinical trials in the region, reviewing each patient with their primary MD or Advanced Practitioner, discussing the study options with potential participants and then forwarding the patient onto the appropriate study site/clinician for potential study enrollment. Follow-up is required to ascertain if patients do actually end up enrolling in the specific studies they were routed to. Perform oncology patient searches in EPIC and match them to potential ongoing oncology trials in their region. All data entry will be performed in REDCap. Required Skills: Bachelor's Degree is required, ideally in the healthcare field. Minimum of two (2) years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, IRB submissions, data management Experience with collecting, organizing, and handling sensitive research data accurately and securely, and Serious Adverse Events (SAEs) are recorded and reported within reporting deadlines outlined in the protocol. At least six (6) months of oncology clinical trials experience is required. Must be fluent in EPIC; experience with REDCap is preferred (but could learn REDCap if needed). Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. Outgoing, friendly and compassionate personality, and ability to interact effectively with patients, families and other providers in a clear and confident manner. Self-starter with the ability to demonstrate a “can do” attitude, and possess strong organizational, time management skills. Capable of independent decision-making, however, needs to know when to escalate and communicate issues to management. Team player - ability to work collaboratively with all team members (i.e., physicians, nurses, staff, and project leadership to ensure that services are coordinated and delivered to patients in a timely manner. Proficient in the use of Microsoft Office applications. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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

Clinical Research Assistant Gastro Florida - Tampa, Florida We are seeking a detail-oriented and dedicated Clinical Research Assistant to join our expanding research department. The successful candidate will play a vital role in supporting our clinical research team in the planning, execution, and documentation of various clinical trials for gastrointestinal conditions including Crohn's Disease, Ulcerative Colitis, IBS, and liver disorders. This position offers an exceptional opportunity to contribute to groundbreaking research that directly improves patient care while working alongside top specialists in the field. Key Responsibilities: Assist in recruiting, screening, and enrolling study participants according to protocol criteria Coordinate and schedule study visits and participant follow-ups Collect, process, and manage biological samples and study data Maintain accurate and detailed records of all research activities Ensure compliance with regulatory requirements and ethical standards Assist in preparing study-related documents and reports Support the principal investigators and research coordinators in daily activities Monitor study progress and report any protocol deviations Communicate with research participants to address questions and concerns Assist in coordinating with other departments involved in trials Qualifications: Bachelor's degree in life sciences, nursing, or related field (required) 1-2 years of clinical research experience (preferred) Knowledge of GCP (Good Clinical Practice) guidelines and ICH regulations Excellent organizational, time management, and multitasking abilities Strong attention to detail and accuracy in data collection and entry Proficiency in Microsoft Office and clinical research databases Effective written and verbal communication skills Ability to work independently and as part of a collaborative team Experience with gastroenterological conditions (a plus) ACRP or SoCRA certification (a plus) What We Offer: Competitive salary and comprehensive benefits package Professional development opportunities and potential for career advancement Work with leading gastroenterologists who are pioneers in clinical research Exposure to cutting-edge treatments and technologies Collaborative and supportive work environment The satisfaction of contributing to medical advances that improve patient care

What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position Overview The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. What You'll Be Working On Duties include but not limited to: Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies 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/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Physical and Travel Requirements This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( What You Bring Knowledge, Skills, and Abilities: Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, "can do" attitude Certifications/Licenses, Education, and Experience: A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred Benefits (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 serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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 currently unable to sponsor work visas. Employment Statement Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world. K2 is seeking a Clinical Research Assistant for our Tampa, FL clinic. The Clinical Research Assistant will: Support clinical trial performance and conduct congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation. Primary Responsibilities: • Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator • Assist the Site Director and Project Management team on projects as needed • Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate • Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator • Articulate all pertinent issues to the Pl or document by email/letter or during meetings • Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources • Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor{s), Auditors and any marketing groups hired by the Sponsor • Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at Compass Research • Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging • Maintain timely K2 Medical Research source documentation as well as sponsor required information. • Dispense and maintain accurate records of study medication • Educate patients and family regarding their study and clinical drug trials in general. • Complete all monitor and sponsor queries in a timely manner • Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study Knowledge, Skills, and Abilities: • Outstanding verbal and written communication skills • Excellent interpersonal and customer services skills • Strong time management and organizational skills In depth knowledge of industry regulations • Proven ability to and foster mentoring relationships • Ability to create momentum and foster organizational change Qualifications: • HS Diploma or GED Transcript required. Bachelor's degree strongly preferred. • Prior experience in a clinical environment preferred. Experience in clinical research is ideal. • LPN, RN, or other medical licensure or certification preferred. • Applicants that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be consider. At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings: Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs. 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested PTO of 16 days per year, 17 days after the first year of FT employment 9 paid Holidays K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.

Department: B6 Unit Status: Full-time Shift: Night Title: Clinical Assistant Nurse Manager ORLANDO HEALTH DR. P. PHILLIPS HOSPITAL Orlando Health Dr. P. Phillips Hospital is an award-winning, full-service medical/surgical facility that has been serving the residents of southwest Orange County and Orlando's growing tourist population since 1985. With a highly qualified team of nurses, support staff and physician specialists, our 285-bed facility provides combined expertise and advanced technology in numerous areas of specialty, including diagnostic imaging, cardiovascular care, orthopedic care, surgical services and emergency medicine. The hospital is equipped with robotic surgical capabilities for colorectal, general, gynecologic and urologic surgeries and has earned Joint Commission certification for its total hip and knee replacement programs utilizing innovative, personalized technologies. Orlando Health Dr. P. Phillips proudly holds recognition as a "Best Regional Hospital" by U.S. News & World Report. Orlando Health Dr. P. Phillips is part of the Orlando Health system of care, which 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 and beyond. Collectively, our 27,000+ team members honor our over 100-year legacy by providing professional and compassionate care to the patients, families and communities we serve. 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 proudly embraces and honors the individuality of our team members. By sharing different ideas and perspectives and working together as a team, we are better able to relate to, care for and authentically serve our patients and families who make up the collective populations in our community. So, no matter who you are, what you believe or how you express yourself, you are welcome here. "Orlando Health Is Your Best Place to Work" is not just something we say, it's our promise to you. Top Reasons to Choose Orlando Health - Dr. P. Phillips Hospital: Competitive Pay: Evening, nights, and weekend shift differentials offered for qualifying positions. All Inclusive Benefits: Student loan repayment, tuition reimbursement, back up elder and childcare, pet insurance, and more for full time and part time employees. Employee-centric: P. Phillips Hospital has been selected as one of the 2020 "Best Places to Work in Healthcare" by Modern Healthcare. Committed to Community: Orlando Health provides more than $450 million in total value to the community in the form of charity care, community benefit programs and services, community building activities and more. Forbes Recognizes Orlando Health as a Best-In-State Employer Forbes has named Orlando Health as one of America's Best-In-State Employers for 2021. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, vice president, Human Resources. "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Responsibilities The Clinical Assistant Nurse Manager (CANM) isresponsible for leading the shift operations within the clinical setting to ensure delivery of high-quality care, exceptional customer experience, and optimal patient flow. In conjunction with the Department Nursing Operations Manager and the Assistant Nursing Operations Manager (ANOM); the CANM provides guidance, fosters collaboration, and is responsible for the unit's clinical operations including patient care assignments, customer experience, productivity, and quality outcomes in settings where an acute care patient receives active treatment for an injury, episode of illness, a medical condition, or post intervention with assessment Essential Functions • Exemplar of the mission, vision, and values of Orlando Health. • Participates in shared leadership structure. • Managesstaffing assignments for oncoming and off going shifts, based on patient acuity and skill set of team members to ensure patient care needs are met. • Coordinates patient flow by working directly with the Administrative Supervisors, Care Coordinators, and Discharge Planners to achieve expected outcomes. • Monitors overall status of patients within area ofresponsibility and closely monitors status ofseriously ill patients. • Coordinates and/or participatesin the delivery of patient care ensuring compliance with physician orders and established policies, procedures, and standards ofpractice. • Serves as a resource supporting frontline team members and providers as appropriate. • Supports clinical collaboration focusing on expected patient length of stay. • Performs direct patient care activities as required to meet operational needs. • Interfaceswithpatients andfamiliesto enhance customer experience by conducting Nurse Leader rounds and investigating and responding to patient/family and physiciancomplaints. • Participates in and/or leads safety huddles. • Embraces, communicates, and promotes change and problem solving. • Assesses equipment needs to ensure staff have the needed equipment for patient care, and they can appropriately utilize equipment. • Supports and sustains all leader-driveninitiatives. • Assists with retention strategies for new team members that fosters a best place to work environment. • Maintains a regulatory ready environment of care. • Ensures the appropriate allocation/adjustment of staff, assignment of meal breaks, relief of team members as indicated, etc. • Utilizes effective fiscal management skills and financial resources with decision-making. • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA, and other federal, state, and local standards. • Maintains compliance with all Orlando Health policies and procedures. Qualifications Education/Training • Bachelor of Science in Nursing Degree (BSN) preferred. Licensure/Certification • Current licensure as a registered nurse in the State of Florida or Nurse Licensure Compact (NLC). • Current Basic Life Support (BLS) certification. • Certification in area of expertise; preferred. • May require one or more of the following certifications based on the assigned patient population: o Advanced Cardiovascular Life Support(ACLS) o Pediatric Advanced Life Support (PALS) o Neonatal Resuscitation Program (NRP) o Trauma Nurse Core Course (TNCC) Experience A minimum of one year of experience as a Registered Nurse; acute care setting preferred Education/Training • Bachelor of Science in Nursing Degree (BSN) preferred. Licensure/Certification • Current licensure as a registered nurse in the State of Florida or Nurse Licensure Compact (NLC). • Current Basic Life Support (BLS) certification. • Certification in area of expertise; preferred. • May require one or more of the following certifications based on the assigned patient population: o Advanced Cardiovascular Life Support(ACLS) o Pediatric Advanced Life Support (PALS) o Neonatal Resuscitation Program (NRP) o Trauma Nurse Core Course (TNCC) Experience A minimum of one year of experience as a Registered Nurse; acute care setting preferred Position Summary The Clinical Assistant Nurse Manager (CANM) isresponsible for leading the shift operations within the clinical setting to ensure delivery of high-quality care, exceptional customer experience, and optimal patient flow. In conjunction with the Department Nursing Operations Manager and the Assistant Nursing Operations Manager (ANOM); the CANM provides guidance, fosters collaboration, and is responsible for the unit's clinical operations including patient care assignments, customer experience, productivity, and quality outcomes in settings where an acute care patient receives active treatment for an injury, episode of illness, a medical condition, or post intervention with assessment Essential Functions • Exemplar of the mission, vision, and values of Orlando Health. • Participates in shared leadership structure. • Managesstaffing assignments for oncoming and off going shifts, based on patient acuity and skill set of team members to ensure patient care needs are met. • Coordinates patient flow by working directly with the Administrative Supervisors, Care Coordinators, and Discharge Planners to achieve expected outcomes. • Monitors overall status of patients within area ofresponsibility and closely monitors status ofseriously ill patients. • Coordinates and/or participatesin the delivery of patient care ensuring compliance with physician orders and established policies, procedures, and standards ofpractice. • Serves as a resource supporting frontline team members and providers as appropriate. • Supports clinical collaboration focusing on expected patient length of stay. • Performs direct patient care activities as required to meet operational needs. • Interfaceswithpatients andfamiliesto enhance customer experience by conducting Nurse Leader rounds and investigating and responding to patient/family and physiciancomplaints. • Participates in and/or leads safety huddles. • Embraces, communicates, and promotes change and problem solving. • Assesses equipment needs to ensure staff have the needed equipment for patient care, and they can appropriately utilize equipment. • Supports and sustains all leader-driveninitiatives. • Assists with retention strategies for new team members that fosters a best place to work environment. • Maintains a regulatory ready environment of care. • Ensures the appropriate allocation/adjustment of staff, assignment of meal breaks, relief of team members as indicated, etc. • Utilizes effective fiscal management skills and financial resources with decision-making. • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA, and other federal, state, and local standards. • Maintains compliance with all Orlando Health policies and procedures.

Job Details RCA-HOSPITAL - FORT LAUDERDALE, FL Full Time Any ResearchJob Description Function: The position trains with other clinical research staff and works directly with physicians to conduct clinical research trials, recruit and consent subjects, and collect and verify accuracy of data. The incumbent also assists in designing clinical trials and skill operationalizing a clinical trial in a clinical study; conducts human subject research involving multiple study sites; ensures IRB compliance; and provides communication to the Principal Investigator. Principal Duties & Responsibilities: Assist in data management, regulatory paper works and other local administrative tasks as supervised by the clinical research coordinator Coordinate research and administrative activities, ensuring all projects are completed according to project/study timelines Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, Institutional Review Board (IRB), grant/contract and study and site specifications Recruit study participants and complete structured clinical assessments with participants Monitor and promptly respond to participant queries Collect and track study data and compile data reports Submit and maintain proper study records, including submission of timely reports to Institutional Review Boards Produce special and recurring reports Other Duties as Assigned: The above information on this portion is designed to present the most essential duties and responsibilities necessary to achieve the positions end results. The occupant of this position is required to follow any other job-related instructions and perform any other duties as requested by Physician Director(s), Clinical Research Manager, and/or Practice Manager. It is the responsibility of each employee to assist other office staff when and where necessary. All employees have the responsibility of answering phones, maintaining files, filing, updating data, and receiving prescription refill orders, etc. Most importantly, it is each staff member's responsibility to project and maintain a positive attitude toward all patients and fellow co- workers. The duties listed may be changed or modified at any time. Qualifications Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors Knowledge of medical terminology Knowledge of good clinical practice, FDA, OHRP, HIPAA policies Familiarity with the Microsoft Office Suite Previous work with CRFs and EDC Excellent organizational skills to independently manage work flow Ability to prioritize quickly and appropriately Ability to multi-task Meticulous attention to detail Education and Experience: Licensed candidates must have an Associate's degree and RN or LPN licensure One year of experience working in clinical research is preferred Psychology background preferred

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