Clinical research associate jobs in Sarasota, FL

This position collects and manages patient and/or laboratory data for a clinical research project. The position oversees the screening and enrollment of clients, gathers and analyzes data on health care programs, develops databases , analyzes data, ensures quality control, and compiles reports for regulatory compliance. Nature of Work: This position typically reports to the principal investigator of a clinical research study. The position may perform evaluation duties in preparation for the project. The position then performs project activities such as overseeing the screening and enrollment of potential clients for a health services protocol, developing materials to communicate the project to potential clients and their families, coordinating site visits and appropriate collection of data, ensuring quality control in the data, and compiling regulatory reports. This position may require specific computer expertise and may require maintaining information on a web site. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge, which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Clinical Research Administrators typically oversee temporary staff or Research Support Specialists. They differ from the non-exempt staff by developing techniques and overseeing clinical data gathering, establishing quality control standards, composing educational materials, and acting as liaison with regulatory agencies. Clinical Research Administrators are not overall project directors. They do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports. Work is distinguished from an Administrative and Business Analyst through its primary emphasis on overseeing client recruiting and testing, and analyzing clinical data rather than general administrative work. This Position is Grant-Funded. Responsibilities Oversees medical or health recruiting and screening protocols, collecting data for research studies. May oversee remote screening locations. Monitors laboratory tests and referrals. Recruits and trains assistants who gather data. Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented. Prepares and maintains regulatory and compliance documents such as IRB applications. Interprets rules and regulations pertaining clinical research to ensure compliance in research projects. Recommends changes in procedures in order to locate, accept, and track clients. Collects and analyzes data from clinical trials or other medical screening. Creates databases for client information or medical records, and analyzes data. Collaborates with social workers and professional agencies to provide services related to health conditions. Composes and disseminates information on studies to clients and the general public. Acts as performance consultant to subcontractors or health departments to produce model quality programs Drafts program reports for publication and/or public dissemination. Provides education to clients and clients' families regarding clinical protocols. Performs other duties as assigned. Qualifications This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.

This position plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives. The position assembles, trains and manages the team assigned to the project. The position documents procedures for the research project and manages reporting and compliance activities, serving as the overall head of project operations. Nature of Work: This position typically reports to the principal investigator of a clinical research study or to an administrator, such as an Assistant Director who oversees many projects. The position may develop protocols and prepare operations manuals at the initiation of a research study. The position then performs project activities such training and indirectly (or directly) supervising project staff, developing materials to communicate the project to potential clients and their families, making site visits to audit activities, ensuring quality control in the data through resolution of inconsistencies, and compiling regulatory reports. The position acts as the primary resource for explaining the project all parties involved. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Sr. Clinical Research Associates typically oversee staff who are assigned to the project but may not directly supervise. Sr. Clinical Research Associates do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports, but the primary purpose is to oversee and conduct the principal project activities. This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience. SB 1310: Substitution of Work Experience for Postsecondary Education Requirements A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: (a) Two years of direct experience for an associate degree; (b) Four years of direct experience for a bachelor's degree; (c) Six years of direct experience for a master's degree; (d) Seven years of direct experience for a professional degree; or (e) Nine years of direct experience for a doctoral degree Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. PREFERRED: Bilingual- Spanish. Certified in Clinical Research with a reputable clinical research society. Master's degree in Biological Science, Public Health, Health Science, Nursing or other directly related field. RN, State of FL. Phlebotomy trained. Experience in REDCAP, EPIC, eBinder software (FLORENCE) or data management/Clinical Research tracking software. Prior management experience preferred. SPECIAL SKILLS/TRAINING: Ability to work independently and in a group setting. Creative problem solver, ability to manage tight deadline, impeccable time management, and excellent verbal and written communication Oversees and designs protocols and electronic case report forms. Develops manual of operations. Reviews medical protocol and prepares draft of document. Coordinates with protocol project manager and study chair preparation of final document for research staff training. Updates the protocols as needed and maintain document version control. Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate. Trains indirect and/or direct reports on policies and procedures, operations, adverse event resolution, protocol creation and review, case report form creation and review, and site data adherence and compliance. Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented. Manages addition of new sites to the network and develops and maintain policies, templates, and related documents for new site additions. Develops and interprets policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP). Collects and analyzes data from clinical trials or other medical screening. Creates data bases based client information or medical records, and analyzes data. Coordinates conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develops related standards, templates and processes. Acts as point of contact and support for consortia research staff.

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999. Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision. Summary Are you looking for an opportunity to impact lives and be a central part of a dynamic and innovative team in the fight against cancer? As a Moffitt Clinical Research Coordinator, you'll bring hope to patients by delivering tomorrow's cancer treatments today! You will have the opportunity to interact directly with patients, enroll, educate and guide them through the experiences of taking part in clinical trials while receiving innovative treatments as part of a therapeutic clinical trial. You will be the member of the Team that ensures the trial is moving forward safely, smoothly, and according to plan. Our Clinical Research Coordinators come from a variety of backgrounds and experiences, including social sciences (public health, social work, sociology, psychology, communications, and more), biological sciences, business, and humanities. The Clinical Research Coordinator role is a terrific opportunity for those who have already worked in other areas of healthcare as well as those who are looking for a new and exciting way to contribute through their career. This position offers a Monday through Friday schedule and hybrid work (mix of remote and on-site) after passing a 90-day introductory and training period. Moffitt offers paid training and orientation through its CTO (Clinical Trails Office) Academy. Position tiers may vary according to experience. Relocation assistance may be provided. ******************************************************************************************** Clinical Trials These positions work closely with patients, patient families, study sponsors (from smaller pioneer biotech companies through large pharmaceutical companies), and the Clinical Trial Team that includes physicians, pharmacists, nurses, data monitors and data managers. Successful candidates will possess: * Effective communication, good decision-making, eagerness to embrace challenges with a sense of urgency and enthusiasm, and time management skills * Excellent teamwork skills and ability to collaborate with those from diverse backgrounds and experiences * Prior experience in clinical trials is preferred * Familiarity with regulatory requirements in clinical research or ability to successfully learn this * Experience interacting with patients and coordinating care with medical staff * Gain a solid learning and understanding of regulatory guidelines and following a clinical trial protocol Job Summary The Clinical Trials Screening Coordinator I reports to the Clinical Trials Office but will directly support a specific Disease Site Program. This position is embedded in the clinic to serve as a single point of contact to aid physicians, clinical team - members and research personnel with timely identification of patients for consideration for clinical trial enrollment. The role performs an integrated approach to ensure effectiveness and efficiencies for directing potential patients to a trial program. The role has the primary responsibility for referring physicians, patients and caregivers to guide, review eligibility and provide access to available clinical trials. This is role is within the clinical trials career path supporting the PI in clinical trials. Minimum Requirements Bachelor's degree in science, health-related field or related project management. 2 years' experience in clinical trials (patient-facing coordination, data management, regulatory or other research coordination). Share:

Job Description Intercoastal Medical Group, Inc is a multispecialty practice serving Manatee and Sarasota counties. Intercoastal is seeking an experienced Clinical Research Coordinator for the Research Department for a full-time weekday shift. For additional information on Intercoastal, please visit **************************** Intercoastal is a drug free workplace and EEO compliant. Monday-Friday 8am-5pm

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Duties include but not limited to: * Ability to understand and follow institutional SOPs. * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Assist with planning and creation of appropriate recruitment materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Attend Investigator meetings as required. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Assist in the creation and review of source documents. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Study Management * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Communicate clearly verbally and in writing. * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * 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. The Expertise Required * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Bilingual in Spanish-preferred How We Work Together * Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the St. Petersburg, FL clinic. * Travel: Regularly planned travel within the region will be required as part of the role. * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Job Description The Clinical Trials Department is seeking a full-time Clinical Research Assistant to support a variety of human subject research studies. This position provides a unique opportunity to work alongside experienced investigators, research coordinators, and clinicians engaged in clinical trials targeting memory disorders, neurodegenerative diseases, brain injury, and environmentally linked health conditions. This is an excellent opportunity for recent graduates or early-career professionals interested in neuroscience, psychology, public health or clinical research. Training will be provided, and there is strong potential for professional growth and advancement within the Institute's research programs. Key Responsibilities Responsibilities include, but are not limited to: Becoming familiar with, and staying current on, lifestyle guidance recommended through our Healthy Aging program Reviewing relevant literature and clinical trial protocols, and maintaining regulatory compliance Preparing and completing source documentation to record subject data Entering subject visit data into sponsor-specific electronic data capture (EDC) systems Maintaining accurate records and tracking clinical supplies Supporting participant visit tracking and internal database documentation Identifying potential study participants via EMR chart reviews or community presentations Conducting telephone pre-screening, explaining study protocols, and determining initial eligibility Scheduling study visits and providing appointment reminders Responding to memory screening requests from the public and managing intake Entering and managing data in-house for internal Roskamp research projects Preferred Skills & Attributes Strong interpersonal and professional communication skills Organized, detail-oriented, and accountable work style Ability to quickly learn multiple data entry and scheduling systems Familiarity with medical terminology and clinical workflows Comfortable working in a team environment and supporting multiple coordinators Experience in cognitive training/cognitive health preferred Able to multitask, prioritize, and remain calm under pressure Qualifications Bachelor's degree in health sciences, psychology, neuroscience, public health, or a related field preferred Experience in clinical research, healthcare, or data management is advantageous Knowledge of HIPAA and GCP (Good Clinical Practice) principles is a plus Candidates with a strong interest in human subject's research and translational neuroscience are encouraged to apply About the Clinical Trials Program The Roskamp Institute's Clinical Trials Division conducts both industry-sponsored and investigator-initiated studies. Current areas of research include: Healthy Aging Alzheimer's disease and mild cognitive impairment (MCI) Traumatic brain injury (TBI) Gulf War Illness Neurological and systemic effects of environmental exposures Ongoing studies include development of a community-based brain health program focused on reducing risk for Alzheimer's Disease. Compensation & Benefits Competitive salary based on experience Paid time off (PTO), paid holidays, and sick leave Health, dental, and vision insurance 403(b) retirement savings plan with employer contribution Opportunities for continuing education and professional development Exposure to cutting-edge translational research and clinical trials Supportive and mission-driven work culture

To participate in a remote work arrangement, employees must reside in the United States. No remote work arrangement will be considered for working from outside the United States. Current employee, faculty or adjunct instructor at Herzing University (not a Contractor or temporary employee through a staffing agency): log into UKG and navigate to Menu > Myself > My Company > View Opportunities to apply using the internal application process. The Faculty Clinical Coordinator will ensure that all assigned faculty meet the credentialing requirements of assigned facilities and that all required paperwork is submitted to the clinical facilities within the required time frame. The coordinator implements and teaches an orientation program for all clinical faculty to ensure that program outcomes are being met. The coordinator documents that the site is meeting accreditation standards at least once per clinical rotation through a site visit or other communication means. Faculty observations will be conducted and documented as appropriate per accreditation requirements. Requirements: * Hold a Graduate degree in nursing. * Hold an unencumbered RN nursing license. Hold a WI Compact license or have the ability to obtain. * Minimum of 2 years experience in as a nurse education within a professional setting OR faculty member within a nursing program at an institution of higher education. * Be proficient with Microsoft Office Suite and internet applications, as well as, be proficient with other technologies currently used in clinical settings. * Experience supervising faculty within a clinical setting is preferred. * Experience teaching nursing students is preferred. * Leadership experience is preferred. PAY: Compensation is determined based on the qualifications, experience, and circumstances of each hire. It is uncommon for new employees to start near the top of the salary range. We offer a comprehensive benefits package, including a tuition waiver and reimbursement program, health insurance, paid time off, and a retirement savings plan with company match. The salary range for this position is $81,800 to 115,800. Click Here to learn more about careers at Herzing University. Clinical Coordination Duties: * Maintain an up-to-date knowledge of the profession to include trends in practice and education, compliance with governing body's policies and procedures, competitive and collaborative practices with regards to other programs in the area, and any other information regarding practice that might impact the achievement of program outcomes. * Identify, select, contract with, monitor, and evaluate all clinical sites.Maintain site selection criteria and contract documentation in support of competency requirements. * Visit all clinical sites at least once each rotation to ensure sites continue to support a relevant and comprehensive experience as appropriate. * Work in conjunction with the program administrator to establish clinical schedules and evaluate student clinical learning experiences. * Work in conjunction with the internship/practicum course coordinator to place students for their internship/practicum assignment. * Advise the program administrator on program areas of interest, i.e. industry trends; program statistics, analysis, and recommendations; clinical site availability, opportunities, and appropriateness; student performance; areas of concern, etc. * Provide recommendations and address concerns to the program administrator on the competency and clinical management skills of clinical faculty, as well as compliance with clinical facility policies and procedures. * Participate in the program planning process. * Comply with all policies and procedures and make recommendations for changes when appropriate. * Establish and maintain a system to ensure the timely and accurate completion and submission of facility, campus, system, government and accrediting agency reports related to the clinical experience. * Participate in Partner relations including, but not limited to, active participation in related professional associations, and building business connections in the community. * Ensure all necessary facility-required documentation and training is completed in a timely and appropriate manner. * Provide orientation, training, and development guidance to faculty and students regarding their clinical site. * Assist the program administrator with the evaluation and training of clinical instructors. * Provide recommendations to the program administrator concerning the upkeep and purchase of subject-specific hardware, software and other media * Serve as the first point of contact for resolution of clinical personnel issues, which may arise between staff at the clinical site and clinical faculty and students. Engages program administrator as appropriate in facilitating the resolution of clinical personnel issues if further intervention is needed. * Participate in course meetings arranged by the course leads to ensure that clinical settings are meeting the needs of the course. * Support and constructively contribute to campus decision-making processes. * Provide advisement support regarding clinical expectations and performance to students. * Participate in professional development activities, professional organizations, and partnership activities. * Accept and complete additional related duties as assigned by the program administrator. Faculty Duties: The primary duties and responsibilities of faculty members at Herzing University are organized according to eight competencies which serve as the basis for instructor hiring, evaluation and development. * Subject Matter Expertise * Effective Communication * Pedagogical Mastery * Operational Excellence * Appreciation and Promotion of Diversity * Assessment of Student Learning * Utilization of Technology to Enhance Teaching and Learning * Continuous Improvement Herzing University is committed to providing a diverse environment and is dedicated to fostering a culture and atmosphere of mutual respect. It provides an inclusive and collegial community where individuals are valued, heard and empowered to contribute to the effectiveness of the institution. Physical Requirements: * Must be able to remain in a stationary position most of the time. * Must be able to occasionally move around the work location. * Must be able to communicate information and ideas so others will understand. * Constantly operates office and/or tech equipment which may include computers, copiers, fax machines, audio/visuals. * Frequently uses voice and hearing to communicate with students, staff or colleagues face-to-face or over the telephone. * Visually or otherwise identify, observe and assess. * Occasionally move, carry, or lift 10 pounds. Applicants must be authorized to work for any employer in the U.S. We do not sponsor or take over sponsorship of an employment Visa at this time. It is the university's practice to recruit and hire without discrimination because of skin color, gender, religion, LGBTQi2+ status, disability status, age, country of birth, veteran status, or any other status protected by law. *************************************** Herzing University prohibits sex-based discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. The notice of nondiscrimination is located at *********************************

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Description Job Summary: The Clinical Research Coordinator II's primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study. Due to enhanced experience at FRI the CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to community, sponsors, CRO's and study participants and family members. Our Culture: Inspire hope. Build your legacy. Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialist, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care. Duties include but are not limited to: Study Preparation: Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc. Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff Assist with planning and creation of appropriate recruitment materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from database Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies Participate in Investigator's meeting and /or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives Create (or review sponsor provided) protocol specific source documents Determine facility, equipment and outsource vendor availability Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Ensure education of staff and/or sub-investigators is completed for required tasks Study Management: Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines Maintain organized files for blank source documents, patient charts, CRFs and supplies EDC entry of required visits within 72 hours of visit elements being completed Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of FRI team in an ongoing fashion Develop and maintain effective relationships with study participants and FRI personnel Complete End of Study Packets for Patient Liaisons Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnel Communicate clearly verbally and in writing Accept accountability for actions and function independently Patient Coordination: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Contact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changed Obtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation required Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manual Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs Review laboratory results, ECGs, and other test results (e.g., biopsy results) for completeness and alert values, ensure investigator review in a timely fashion Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaround Dispense study medication per protocol and or IVRS system. Educate patient on proper administration and importance of compliance Monitor patient progress on study medication Documentation: Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP Accurately record study medication inventory, medication, dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashion Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients' charts and regulatory filing if necessary Ensure all sponsor correspondence (emails, telephone conversations) are printed and given to appropriate personnel for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all- inclusive. Knowledge, Skills, and Abilities: Good working knowledge of medical and research terminology Enhanced working knowledge of federal regulations, good clinical practices (GCP) Ability to mentor and guide less experienced CRCs as they develop and gain experience Ability to communicate and work effectively with a diverse team of professionals Excellent organizational, prioritization and leadership skills and capabilities Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel Excellent interpersonal skills, detailed-oriented and meticulous Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision Experience: Two years clinical research experience Two years Clinical Research Coordinator experience A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form License/Certification: RN or LPN preferred Research Professional Certificate- CCRC or exam eligibility preferred When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!

Job Description The Clinical Research Assistant will assist the Clinical Research Coordinators (CRC) in the conduct of industry-sponsored clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. To support study conduct, the candidate should have experience in research, clinical trials, or a related field. The individual should be familiar with the processes involved in conducting research studies and should have experience in the collection and management of data. The RA is immediately accountable to the CRC and works with them and other study team members to meet study-specific goals and timelines and communicate appropriately and effectively with subjects, investigators, CRC's, and other staff. Organizational skills are critical in this role. The candidate should be able to manage multiple tasks, keep detailed records, and maintain an orderly work environment. Attention to detail is also essential, as the individual will be responsible for ensuring accuracy in all aspects of the study. Professionalism is another critical attribute. The individual should have excellent communication skills, be able to work collaboratively with others, and maintain a high level of confidentiality Clinical and Administrative Ability to perform clinical tasks including assisting the Principal Investigator, Sub-Investigators and study coordinators with study procedures and other study requirements as needed Ability to work as a team and independently. Under the direction of the CRC, Investigator, Supervisor and Clinical Operations Manager Perform study activities according to the protocol and standard operation procedures, follow instructions, perform other duties as needed Good communication and time management skills Flexible and self-motivated Ability to follow responsibilities to completion Basic computer skills May be added as a back-up study coordinator to help conduct studies. Assist with enrollment of new patients Follow Up with phone calls Pre-Screen & Screen patients Conduct Informed Consent process Must be ok with venipuncture and blood draw Must be able to perform data entry This individual will work with study registries and must be organized and comfortable with typing and performing data entry Must be ok with the shipping and handling of study specimens Professional Demonstrates initiative and responsibility Able to perform repetitive tasks without loss of focus Adheres to ethical principles This is the compensation range for this position. Compensation Range$45,000-$53,000 USD

Job Description The Clinical Coordinator position plans, coordinates, facilitates, administers, and monitors, activities on behalf of the academic program and in coordination with academic and clinical faculty. These activities ensure the quality of our students learning experience during clinical education. Clinical Coordinators accomplish this through: Assists with the development and assessment of the clinical education component of the curriculum with the Program Director. Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation. Responsible for facilitating students' clinical education. Responsible for ensuring clinical education program compliance. EDUCATION, EXPERIENCE AND TRAINING: Minimum of a bachelor's degree At least 2 years of clinical practice experience in the professional discipline Proficient in curriculum development, supervision, instruction, evaluation, and academic advising Documents one year's experience as an instruction in a JRCERT accredited program Current, American Registry of Radiologic Technologists (ARRT) certification and registration, or equivalent, in radiography

Job Description K2 is seeking a Clinical Research Assistant (1099) to support our clinic out of Tampa, FL. 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 K2 Med. 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. Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you. We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at HR@k2med.com, and we'll ensure you have everything you need to shine.

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999. Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision. Summary Are you looking for an opportunity to impact lives and be a central part of a dynamic and innovative team in the fight against cancer? As a Moffitt Clinical Research Coordinator, you'll bring hope to patients by delivering tomorrow's cancer treatments today! You will have the opportunity to interact directly with patients, enroll, educate and guide them through the experiences of taking part in clinical trials while receiving innovative treatments as part of a therapeutic clinical trial. You will be the member of the Team that ensures the trial is moving forward safely, smoothly, and according to plan. Our Clinical Research Coordinators come from a variety of backgrounds and experiences, including social sciences (public health, social work, sociology, psychology, communications, and more), biological sciences, business, and humanities. The Clinical Research Coordinator role is a terrific opportunity for those who have already worked in other areas of healthcare as well as those who are looking for a new and exciting way to contribute through their career. This position offers a Monday through Friday schedule and hybrid work (mix of remote and on-site) after passing a 90-day introductory and training period. Moffitt offers paid training and orientation through its CTO (Clinical Trails Office) Academy. Position tiers may vary according to experience. Relocation assistance may be provided. ******************************************************************************************* These positions work closely with patients, patient families, study sponsors (from smaller pioneer biotech companies through large pharmaceutical companies), and the Clinical Trial Team that includes physicians, pharmacists, nurses, data monitors and data managers. Position Highlights: * Supports the Principal Investigator (PI) in clinical trials by implementing and coordinating research including administrative procedures at Moffitt Cancer Center. * As the primary resource for the protocols, the CRC II will coordinate patient care by collaborating with medical staff, and document in accordance with standards and regulatory guidelines. * Will act as liaison between the investigators, care providers, Moffitt regulatory staff and the sponsor. * Along with the investigator, the CRC II will screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. * The CRC II will perform all Clinical Research Coordinator core support and additional responsibilities of more complex studies, with a higher patient volume. * The CRC II is responsible for determining methods and procedures for the coordination of newly assigned studies. Credentials and Qualifications: * *Bachelor's degree with 2 years clinical trials coordination experience * *In lieu of a bachelor's degree, an associate's degree with 4 years clinical trials coordination experience may be considered * CCRP/CCRC certification preferred. Share:

A Unit Research Administrator supports researchers by preparing budget projections, developing materials for compliance analysis, and advising the researchers concerning the review of the proposals by Sponsored Research. The position researches internal and external grant sources and disseminates information on grant opportunities of interest to researchers in a college or department. After awards are made the position provides guidance to researchers on administrative steps such as setting up accounts, hiring staff, reconciling the projects on a regular basis, reviewing and approving invoices and financial reports prepared by Sponsored Research, preparing expenditure transfers and override requests with supporting justification, and reviewing the final reconciliation of the projects prepared by Sponsored Research. A Unit Research Administrator does not support a single research program, but works with many research proposals and projects. This position meets the FLSA criteria for a professional exemption since it performs work that requires advanced knowledge, skills and judgement. The work is distinguished from general administrative support positions by consulting primarily on research projects and assisting in grant proposal development, compliance review processes, and fiscal administration. It differs from the roles of Sponsored Research since it does not negotiate nor contract with granting agencies, as it does not have the authority of the central administrative offices that are responsible for financial audits, contact with the sponsor, submitting and/or executing proposals and awards on behalf of USF. • This position requires a Bachelor's degree and 1 year of professional administrative experience; or a Master's degree. Progressively responsible related experience may substitute for the required education on a year for year basis. • Senate Bill 1310- The Florida Senate (************************************************ is conditional upon meeting all employment eligibility requirements in the U.S. • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements • A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: • (a) Two years of direct experience for an associate degree; • (b) Four years of direct experience for a bachelor's degree; • (c) Six years of direct experience for a master's degree; • (d) Seven years of direct experience for a professional degree; or • (e) Nine years of direct experience for a doctoral degree • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. • Minimum Qualifications that require a high school diploma are exempt from SB 1310. • Finds and promotes grant opportunities. Identifies sources of funding for the conduct of research and/or service programs. Provides assistance and guidance to facilitate the development, administrative review, and funding process for faculty. • Conveys proposal guidelines to researcher. Reviews applications for research projects for format and completeness. • Reviews award budget and expenditures (expenses, equipment, and salaries) for compliance with grant terms and unit guidelines. • Reconciles projects on a monthly basis, prepares documents to correct expenditures in keeping with the budget categories, and maintains supporting documentation. • Assists with budget and activity reports on active grants to Sponsored Research. • Keeps statistics on unit research activities. • Coordinates internal proposal submission and approval. Meets with faculty regarding budget questions and resource commitments. Coordinates meetings of department faculty with research administration and compliance committees. • Monitors Institutional Review Board/Institutional Animal Care and Use Committee closure dates from the Applications for Research Compliance portal, and when technical and financial reports are due consistent with the terms and conditions of the award. Maintains vitae of researchers. • Performs other duties as assigned.

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research 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. How You'll Make An Impact 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. The Expertise Required 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 California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in St. Petersburg, FL Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $38.00 USD per hour for full time team members. Benefits & Perks (Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

The Clinical Coordinator position plans, coordinates, facilitates, administers, and monitors, activities on behalf of the academic program and in coordination with academic and clinical faculty. These activities ensure the quality of our students learning experience during clinical education. Clinical Coordinators accomplish this through: Assists with the development and assessment of the clinical education component of the curriculum with the Program Director. Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation. Responsible for facilitating students' clinical education. Responsible for ensuring clinical education program compliance. Minimum of a bachelor's degree At least 2 years of clinical practice experience in the professional discipline Proficient in curriculum development, supervision, instruction, evaluation, and academic advising Documents one year's experience as an instruction in a JRCERT accredited program Current, American Registry of Radiologic Technologists (ARRT) certification and registration, or equivalent, in radiography

This position typically reports to the Principal Investigator, Clinical Research Manager, or Clinical Research Coordinator. This job is a pre-entry position for the Clinical Research Coordinator career path. Within its specialized support duties, it receives moderate supervision. Handles basic issues and problems and refers more complex issues to higher-level staff. The assignments are semi-routine in nature, including collecting and entering data and working with the study coordinator to ensure their accuracy and integrity, in strict adherence to study protocols. Requires knowledge and experience with basic computer skills and web-based applications. This is a Grant-Funded Position. This position is NOT eligible for Visa Sponsorship. • High School Diploma or equivalent required. • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. Degree Equivalency Clause: Four years of direct experience for a bachelor's degree. • Senate Bill 1310- The Florida Senate (************************************************ is conditional upon meeting all employment eligibility requirements in the U.S. • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements • A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: • (a) Two years of direct experience for an associate degree; • (b) Four years of direct experience for a bachelor's degree; • (c) Six years of direct experience for a master's degree; • (d) Seven years of direct experience for a professional degree; or • (e) Nine years of direct experience for a doctoral degree • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. • Minimum Qualifications that require a high school diploma are exempt from SB 1310. • Assists with the evaluation of potential research participants with the study team and Principal Investigator. • Assists with screening, enrollment, and retainment of study participants at the site. • Schedules participant site visits and maintains records. • Assists Clinical Research Coordinators and site study team in recording data on each study participant for each visit according to research protocol. • Assists with the implementation of procedures and activities of assigned study protocols. • Participates in coordinating, preparing, and conducting site monitoring visits, audits, and inspections. • Collects vitals and assists study coordinator with patient visits at the site. • Collects study specimens according to the protocol which may include phlebotomy, processing, and preparation for shipping. • Performs data entry for clinical trials. • Assists with site quality assurance and tracks regulatory submissions. • Performs other duties as assigned.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research 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. How You'll Make An Impact * 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. The Expertise Required * 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 * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in St. Petersburg, FL * Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $38.00 USD per hour for full time team members. Benefits & Perks (Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

The primary purpose of this position is to be the main point of contact for sponsors and patients for specific research protocols. This position is responsible for performing the screening, enrollment, and retention of study participants, ensuring quality of data collected throughout the research study, and implementing the procedures and activities under the direction and oversight of the lead coordinators and principal investigators of the projects. Minimum Education & Experience • Bachelor's degree in a related field -OR- equivalent combination of education and experience. • Minimum of two (2) years of related experience. • Senate Bill 1310- The Florida Senate (************************************************ is conditional upon meeting all employment eligibility requirements in the U.S. • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements • A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: • (a) Two years of direct experience for an associate degree; • (b) Four years of direct experience for a bachelor's degree; • (c) Six years of direct experience for a master's degree; • (d) Seven years of direct experience for a professional degree; or • (e) Nine years of direct experience for a doctoral degree • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. • Minimum Qualifications that require a high school diploma are exempt from SB 1310. Knowledge, Skills & Abilities • Comprehension of clinical research principles, Good Clinical Practice Guidelines, and regulatory requirements. • Attention to detail, critical thinking, ability to follow protocols, • Ability to maintain quality standards, planning and scheduling, data collection, clear communication, and organization. • Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment. • Ability to provide technical advice, guidance, and support to professional and support staff • Skill in the use of personal computers and related software applications. Working Conditions • Environment - Typical indoor environment/office setting. • Physical Requirements - climbing, standing, stooping, and/or typing; Ability to lift up to 20lbs as needed. • Travel - Ability to travel to other USF campuses and/or other locations as requested. Primary Job Duties • Plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives at a single site. • Coordinates and performs patient clinical assessments for clinical trial visits for assigned clinical trial protocols including scheduling with vendors which may include other departments or outside facilities. This may include phlebotomy, sample processing, vitals, ECGs and other delegated clinical assessments per assigned protocols. • Communicates as a site representative with study sponsors, third party vendors, clinical teams and patients to ensure all protocol required elements are being completed and collected within the defined windows. • Ensures site compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends site monitoring meetings with sponsors. • Manages the site research project databases, develops flowsheets and other study related documents, and completes source documents/case report forms. • May provide guidance to other clinical research staff and support personnel. • Makes recommendations of procedures in order to facilitate protocol compliance. • Performs data entry and query resolution during the duration of each trial assigned. • Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes at the site. • Performs other duties as assigned.