Clinical research coordinator jobs in Town North Country, FL

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 Position Highlights: * The Clinical Research Coordinator Associate is a support position that administers duties related to the collection of data and/or the coordination of clinical trials, at Moffitt Cancer Center. Activities support assigned research protocols and include the coordination activities of assigned research protocols (generally non-therapeutic in nature) including obtaining informed consent from study participants, specimen collection and data entry. * The job is a pre-entry position for the Clinical Trials Coordinator career path or other medical or research career paths. * Other job duties may include support of therapeutic studies including completion of data entry into various database systems, follow-up of patients according to protocol (via review of records, clinic visit or telephone call), ordering supplies, preparing patient/participant documents for study visits, assisting with the maintenance of regulatory documents, communicating with study sponsors, and facilitating the collection of study-required specimens. * The position applies job skills and company policies and procedures to complete assigned tasks. Within its administrative support duties, it receives moderate supervision. The assignments are semi-routine in nature, but the CRC Associate recognizes the need for occasional deviation from accepted practice. Requires instructions only on new assignments. Credentials and Qualifications: * *Associate's degree * *In lieu of an associate's degree, 2 years of relevant experience required with a high school diploma or GED * Bachelor's degree preferred in scientific, health related or business administration program. Share:

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.

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

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.

Job Title: Clinical Research Coordinator Contract Duration: 6 Months Hours: 7am-4pm Job Summary: The Research Coordinator is responsible for coordinating multiple research protocols and serving as aliaison with local investigators and sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations to achieve a fundamental understanding of human subject research. Key Responsibilities: * Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement." * Complete assigned training requirements by the due date. * Perform routine operational activities for multiple research protocols. * Liaise between site research personnel, industry sponsors, and supervisor. * Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable. * Coordinate schedule of assessments from initial submission of feasibility until study closeout. * Review the study design and inclusion/exclusion criteria with physician and patient. * Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements. * Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitor data for missing or implausible data. * Create study-specific tools for source documentation when not provided by sponsor. * Collect, complete, and enter data into study-specific case report forms or electronic data capture systems. * Generate and track drug shipments, device shipments, and supplies as needed. * Ensure timely and accurate data completion. * Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations. * Communicate all protocol-related issues to appropriate study personnel or manager. * Attend study-specific on-site meetings, investigator meetings, conference calls, and monthly CRC meetings, as required. * Review and respond to any monitoring and auditing findings. Qualifications: * 1+ years of relevant experience. * Bachelor's Degree required. * Occasional travel: The job may require travel from time to time, but not on a regular basis. Skills: * Strong organizational and time management skills. * Excellent communication and interpersonal skills. * Ability to work collaboratively with various departments and teams. * Attention to detail and accuracy in data collection and reporting. * Familiarity with research protocols and regulatory requirements. Pay and Benefits The pay range for this position is $30.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Largo,FL. Application Deadline This position is anticipated to close on May 9, 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Requirements On-the-job training Competitive pay Company paid holiday Team camaraderie and spirit The Clinical Operations Specialist - Seasonal will perform multi-faceted job responsibilities that are narrow and wide in scope to include administrative, finance, and clinical pre-operative duties. Duties & Responsibilities: Maintains a professional appearance and attitude at all times as a representative of Mia Aesthetics when interfacing with all patients and vendors Performs clerical and administrative roles when needed according to the demands of the business Promotes a progressive attitude for continued improvement of patient care and customer service Tracks inventory for surgical and clinical accessories/supplies for designated department Maintains confidentiality at all times and safeguards patients medical records/HIPAA Champions a safe, secure, and healthy work environment by complying with OSHA/ legal regulations Pre-Operative: Charges and collects all payments for all surgeries, surgical accessories, and Mia merchandise Generates daily invoices while processing financial transactions to balance end of day Confirms surgical patient appointments and sends out schedules to their respective teams daily Takes pre-operative photos and process electronic prescriptions for doctors Ability to create patient charts, record keeping, and filing in a timely manner In charge of preliminary physical test such as vitals needed the day before all surgeries Verifies patient labs, intake information, and consents prior to and the day of surgery Day of Surgery: Prepares each patient for surgery by having them undress, collecting urine samples for POC testing and verifying all post-surgical instructions Performs POC testing (.e.g., drug testing, HCG testing, nicotine testing) Chaperones providers during immediate consultations Scribes operative reports for Surgeons at the end of every surgical case Ensures invoices, sumo calendar, and charts have matching patient information day of surgery Confirms all surgical procedures with patient as well as medical history and demographic information Educates patient by transmitting physician's orders and answering questions in regard to surgery Performs other duties as assigned Required Skills/Abilities: Excellent verbal and written communication skills Outstanding customer service skills Ability to work with a high sense of urgency and ability to prioritize work Excellent organizational skills and attention to detail Ability to work rotating shifts Strong computer literacy skills Education and Experience: GED or High School Diploma Active Registered or Certified Medical Assistant preferred Plastic Surgery knowledge preferred Minimum 1-2 years of customer service experience Experience working in an operating room preferred Bilingual in English and Spanish preferred HIPAA & OSHA Compliance Certification preferred Maintains and holds an active Basic Life Support (BLS) Certification Physical Requirements: Prolonged periods of standing, bending, and reaching low or overhead Prolonged periods of sitting at a desk working on a computer

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 Details Florida West Coast Skin and Cancer Center (FWC) - Tampa, FLDescription We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of clinical research coordinator. Clinical research coordinators are responsible for conducting clinical research trials by adhering to Good Clinical Practice (GCP), International Air Transportation (IATA) and FDA regulations. The candidate will be performing required visit procedures, administering questionnaires and subject material, adhering to regulatory trial standards, and participating in subject recruitment efforts, among other duties. Clinical research coordinators need to engage with the research investigators, pharmaceutical companies (sponsors) and contract research organizations (CROs) as well as the research subjects requiring excellent interpersonal and communicative skills. Clinical Research Coordinator Responsibilities: Overseeing the smooth running of clinical trials. Performing clinic visits as per the protocol, GCP and FDA Completing procedures such as phlebotomy, EKGs Vitals, assessments Collecting and entering data obtained for the trial Informing participants about study objectives. Administering questionnaires. Monitoring research participants to ensure adherence to study rules. Adhering to research regulatory standards. Adhering to ethical standards. Maintaining detailed records of studies as per FDA guideline and regulatory documentation Managing investigational medication including receiving, dispensing, storing and performing accountability Liaising with laboratories process, ship and ensure investigators review reports Participating in subject recruitment efforts. Ensuring that the necessary supplies and equipment for a study are in stock and in working order. Engaging with subjects and understanding their concerns and managing the visit flow as indicating in the protocol. Qualifications Qualifications: Attention to detail. Exceptional interpersonal skills. Good computer and technical skills Outstanding written and verbal communication. Excellent organizational skills. Willingness to continually self-educate. CCRC certification a plus Bi-lingual in Spanish is a plus

Country: United States of America At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages. Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance. A LITTLE BIT ABOUT FCS Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network. Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care. We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval. Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients. Come join us today! RESPONSIBILITIES Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the research director. The research coordinator is responsible for the overall successful implementation and ongoing site management of the research studies. May be responsible for providing coverage in clinics when research staff are out of the office; for precepting new research staff in clinics; for assisting with research projects assigned by the Senior Clinical Research Coordinator III. QUALIFICATIONS Candidates must have a valid RN license, in state of employment, a minimum of one-year oncology or clinical research experience; or a minimum of five years of combined clinical oncology and clinical research experience. Candidates must have effective communication skills, be organized, detail oriented, strong patient advocates. Candidates must be available to travel to investigator meetings. Valid Driver's License, in state of residency, for travel to clinics. Must comply with the Company's Driver Safety Operations and Motor Vehicle Records Check Pol #LI-DL1 SCREENINGS - Background, drug, and nicotine screens Safeguarding our patients and each other is an important part of how we deliver the best care possible to the communities we serve. All offers of employment at Florida Cancer Specialists & Research Institute are contingent upon clear results of a thorough background screening. Additionally, as a condition of employment, FCS requires all new hires to receive various vaccinations, including the influenza vaccine, barring an approved exemption. In addition, FCS is a drug-free workplace, and all new hires will be subject to drug/ nicotine testing. Medical Marijuana cards are not recognized. EEOC Florida Cancer Specialists & Research Institute (FCS) is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at FCS, please email FCS Recruitment (**********************) for further assistance. Please note this email address is intended to request an accommodation as part of the application process. Any other correspondence will not receive a response. FCS is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Education Bachelor's degree in Science or Healthcare related field Certification Good Clinical Practice certification or completion within 3 months of hire Basic Cardiopulmonary Life Support or completion within 6 months of hire IATA Dangerous Goods or equivalent training Work Experience A minimum of three (3) years of clinical research experience, including at least 2 years specifically focused on specialty clinical research. Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas. Phlebotomy experience or completion of course work within six months of accepting the position. An equivalent combination of education and years of experience or realized competencies. Technical Knowledge, Skills, and Abilities · Intimate knowledge of advance and complex experimental design, statistics, computerized databases · Demonstrated ability to understand and implement scientific protocols · Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas · Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection · Ability to work with spreadsheets (such as Excel), familiarity with databases (ex\: Medidata RAVE, iMedra, Velos, etc) and querying. · Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated multi-disciplinary team · Exceptional attention to detail and excellent technical problem-solving skills. · Excellent organizational skills and ability to prioritize and be flexible to manage multiple tasks. · Excellent oral and written communication skills. · Intermediate proficiency in Microsoft Office. · Ability to travel between clinical sites, whenever required The Clinical Research Coordinator 2 provides independent coordination of multiple, complex clinical research studies in order to ensure the efficiency and accuracy of clinical studies through all stages as the study progresses and shows vigilance in participant safety, protocol compliance, and data quality. This position may also provide guidance to other clinical research staff and support personnel. The Clinical Research Coordinator 2 evaluates, initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies, sponsors regarding study activity, as well as affiliated departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Participates, as needed, in the regulatory processes as they relate to the evaluation, initiation, maintenance, closure of studies, internal and external audits of clinical trials, and other research activity. Coordinates and oversees subject activity as it relates to the conduct of research and clinical trials. Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines and regulatory requirements. Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity. Supports department, division, and institutional goals. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards. Follows regulatory requirements, established policies, procedures and professional guidelines in planning, implementing, documenting and reporting study requirements. Responsible for maintaining study files, logs, data entry and management of databases for clinical research studies. Participates as needed in the regulatory document submissions as required by the sponsor of the trial, regulatory agencies, and TGH research policy. The coordinator is responsible for performing job duties in accordance with the mission, vision and values of the Office of Clinical Research and Tampa General Hospital. Full time presence in the office is required.

Department Operations Employment Type Full Time Location Accel Research Sites - Lakeland, FL Workplace type Onsite Reporting To Colleen Figueroa Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.

About Us Catalyst Labs is a leading talent agency specializing in Tax, Tax Technology and Transfer Pricing. We stand out as an agency that is deeply embedded in our clients recruitment operations. We work directly with hiring managers such as Partners and Directors of Big 4/ Big 6 and Big 20, in-house Tax leaders such as CFOs and Head of Tax and startup founders in the Tax Tech ecosystem, who understand the value of strategic tax leadership, and we take pride in facilitating conversations that are aligned with your expertise and long-term goals. Our Client: A fast-growing technology company reshaping digital vehicle commerce based in New York that raised $17m in Funding. Their lightning-fast checkout platform has already driven tens of millions in revenue for over 20 major automotive partners who rely on their technology to power online sales. They support a diverse mix of publicly traded enterprises generating billions in annual GMV, rapidly scaling new entrants backed by significant venture funding, and an extensive network of dealerships. Location: New York Work type: Full time, Hybrid (In-person 4 days/week in NY) Overview The Tax & Compliance Research Specialist will be responsible for establishing and maintaining a comprehensive sales and use tax system for vehicle sales across all U.S. states. The role includes conducting tax research, managing compliance processes, and ensuring accurate reporting and remission. After establishing the tax framework, this position will support wider operational research projects, including DMV compliance and other regulatory initiatives, helping to build a strong compliance framework for the organization. Key Responsibilities Conduct ongoing research on sales and use tax requirements for vehicle sales across all 50 U.S. states. Develop, document, and manage full tax reporting and remission workflows. Assist with audits, reconciliations, and continuous process improvements. Keep thorough records to support filings, compliance checks, and future reviews. Contribute to broader operational research, including DMV regulations, compliance initiatives, and other regulatory topics. Qualifications Required Minimum 2 years of experience in tax compliance, tax accounting, or a similar field. Strong understanding of multi-state Sales and Use Tax processes and remission. Ability to research and interpret state tax statutes, rules, and regulatory requirements. Experience using tax technology platforms; Vertex experience is a major plus. Willingness to take initiative on non-tax projects, including DMV and regulatory research. Based in (or open to relocating to) New York City. Qualifications Preferred Background in automotive or vehicle-related tax compliance. Excellent communication skills with the ability to collaborate across finance, operations, and external teams. Proven ability to work independently in a fast-paced startup environment. Note: We adhere to strict data protection policies to ensure that your information is secure and only shared with potential employers with your explicit consent to ensure your confidentiality throughout the hiring process

YOU BELONG HERE What Awaits You? * Career growth and development * Employee and Dependent Tuition Assistance * Diverse and collaborative working environment * Affordable and comprehensive benefits package * Our competitive Benefit Package is designed to support the well-being and financial security of our employees. You can explore the details of our benefits offering by visiting the following link Johns Hopkins All Children's Hospital | Your benefits virtually (mybenefitsjhhs.com) Summary: An advanced member of the study team who under the direction of the Principal Investigator and Director of Research Operations is responsible for the overall coordination of assigned studies including screening, recruitment, data collection, and data entry to ensure protocol compliance and human subjects' protection. Key Accountabilities * Serve as the primary coordinator on more-than-minimal-risk, high acuity, and/or complex studies. Serves as the liaison between study team, research cores/units/departments, ancillary hospital departments/services, sponsor, and IRB to ensure cross-communication and protocol compliance * Delegate tasks to the Clinical Research Coordinator I and Research Assistant in accordance with the delegation of authority log to ensure study is executed appropriately and efficiently * Coordinate the preparation and submission of regulatory documentation to the sponsor and Institutional Review Board (IRB) during all phases of study conduct including start-up, continuing reviews, changes in research, problem events, and closure to ensure human subjects protections and regulatory compliance * Operationalize the recruitment plan and obtain or coordinate the informed consent process to ensure the participant understands the information and volunteers to participate free of coercion * Coordinate and/or perform study visits/interventions/observations to ensure they are conducted according to protocol * Monitor participants for adverse events and study conduct for protocol deviations and events and report accordingly to Principal Investigator, sponsor, and IRB to ensure participant safety and protocol compliance, and participate in the Corrective and Preventative Action planning where applicable * Coordinate and perform data collection from various sources including medical records and enter data into research database to ensure accurate and timely data entry * Maintain organized and up-to-date research records including regulatory binders and participant records to ensure study documentation is audit-ready * Qualifications: * Bachelor's degree in science or health related field * 3 years of prior clinical research coordination or nursing experience required * Certified as a Clinical Research Professional, or will obtain CCRP within 6 months of becoming eligible, but no later than 2 years after hire * Demonstrates knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations and other federally mandated guidelines * Must be comfortable working with patient populations * Computer competency in using Microsoft Office including Word, Excel, and Outlook; prior experience with Electronic Data Capture (EDC) systems or databases is preferred Salary Range: Minimum 27.44/hour - Maximum 43.91/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority. We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices. Johns Hopkins Health System and its affiliates are drug-free workplace employers.

Department Women's Cancer Care Grant Prepares and submits regulatory submission to IRB and sponsors, documentation compliance for multiple study projects, audit preparation, and data submission. This position also will be responsible for advising patients of trial design, facilitating informed consent for investigators, following strict adherence to protocol procedures specific to each study, screening for possible trial patients, eligibility criteria, and patient follow up. This position is responsible for coordination of trial activities mentioned above as well as others. Required Qualifications * Require research certification within one (1) year of eligibility. * Require a minimum of five (5) years of healthcare experience with two (2) of the years being within a research role. * Require completion of Good Clinical Practice & Human Subject Protection and Safety Handling/Hazardous training within two (2) weeks of hire/transfer date.. Preferred Qualifications * Prefer in-depth knowledge of good clinical practices as set forth by Federal regulations. * Prefer an organized individual with strong critical thinking skills who has the ability to work efficiently under pressure. * Prefer someone who is highly motivated, shows initiative, is proactive, and able to work independently as well as in a team. Mandatory Education A D: Associate's Degree Preferred Education BD: Bachelor Degree Required License and Certs Preferred License and Certs

Posting Date 12/03/2025 10770 N 46th StSuite A100, Tampa, Florida, 33617, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be? If you haven't considered Nephrology before, read on as we think that you should. DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice. Some details about this position: * At least 6 months dialysis experience is required. * Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. * Training may take place in a facility or a training clinic other than your assigned home clinic * Potential to float to various clinics during and after your training * You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can expect: * Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. * Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. * Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. * Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. * You will work with your head, heart and hands each day in a fast paced environment. What we'll provide: DaVita Rewards package connects teammates to what matters most including: * Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out * Support for you and your family: family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave, pet insurance, and more * Paid training Requirements: * Current Registered Nurse (RN) license in the state of practice * Current CPR certification required * At least 18 months of registered nursing experience * Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required * Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred * Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred * Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree * Current CPR certification required * Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system * Supervisory experience preferred; willingness, desire, and ability to supervise required * Basic computer skills and proficiency in MS Word and Outlook required DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives. Ready to make a difference in the lives of patients? Take the first step and apply now. At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

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 Moffitt Research Institute is recruiting for a CTLC Research Sampling Coordinator I in the Clinical Trials Laboratory Core in Tampa, FL. Position Highlights: * The Research Sampling Coordinator I (RSC I) assumes the responsibility of supporting and performing clinical research sample processing within the Clinical Trials Laboratory Core. * The RSC I will normally receive daily instructions for routine work and detailed instructions for new assignments in regards to the preparation, collection and processing of protocol samples. * The RSC I will be familiar with and follow established procedures and supported protocols within the lab while under supervision. * The RSC I will also routinely perform specimen packaging for shipment under IATA 1.5 requirements for dangerous goods. * The role requires the potential for travel between Moffitt campuses or Satellite campus locations to support core services. The Ideal Candidate: * Excellent organizational skills * Excellent attention to detail * Excellent time management skills Responsibilities: * Schedules incoming core service requests. * Prepares protocol specific, visit specific, collection materials and delivers for next day usage to location customers. * Processes routine liquid preparations and also has the potential to support more complex preparations with some degree of supervision. * Prepares shipments of biological samples for external central labs and other vendors that are performing offsite analysis. * Collects, organizes and files protocol specific data on a weekly basis. * Maintains laboratory equipment in a clean and working order including performing instrument standardization and freezer maintenance. * Serves as a resource to members of the Clinical Trials Office when called upon in lab. * Maintains QA program which includes: * Keeps self-current with laboratory trends and techniques, including biosafety and IATA 1.5 diagnostic shipping training and certification. * Follows infection control techniques for preparation, handling, and possible disposal of samples. * 95% of the time in a laboratory, in the presence of reagents and dry ice while handling human biological fluids. 5% of the time in location customers around the cancer center, including clinical units, hospital patient floors and wings. Credentials and Qualifications: * High School Diploma or GED with 3 years laboratory experience in academic, industry, clinical, research, or veterinary lab is required * Associate's Degree in Biological Science or related field with 1 year laboratory experience in academic, industry, clinical, research, or veterinary lab (OR) Bachelor's degree in Biological Science or related field with no experience * IATA Hazardous Material Shipment Certification (obtainable after employment start) * Research-based experience preferred. * Core-specific licensure and/or certifications are preferred. * Human Subjects and Good Clinical Practices training through CITI is preferred. Share:

The Clinical Research Coordinator II is responsible for coordinating and performing research related activities for clinical research projects as assigned. 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. • 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. • 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.

The Department of Neurology Movement Dis Division conducts a very high volume of clinical research. The research also seeks to understand more about the disease and its progression. Coordinates multiple studies independently with high enrollment. Will facilitate training of clinical research staff as required per protocol. Coordinates the more complex clinical trials per protocol requirements and assists junior staff with troubleshooting to avoid protocol deviations. Manages inventory of supplies and assists with forecasting needs for future studies. Responsibilities 35%- Provides direct support to lead coordinator or coordinate and serves as project lead for projects that are simple to moderate in complexity at the site level. Coordination, communication and completion of assessments for clinical trial patients (including complex protocol requirements). Includes preparation for clinical research visits (chart preparation). 25%- 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. Participates in the screening, enrollment, and retention of study participants at the site. 15%- Conducts study visits and data collection throughout research study. Collaborates with the preparation and submission of site study documents. Assist with coordination, preparation, and conduct of site monitoring visits, audits and inspection. 10%- Training of new site staff, ongoing training (amendments), documentation of training. Act as resource for junior staff, assist with other projects as needed (fiscal). 10%- Monitor clinical study activity at the site to ensure compliance with the protocol, site SOPs (Standard Operating Procedures) and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations. 5%- Performs other duties as assigned. Qualifications Bachelor's degree in a related field -OR- equivalent combination of education and experience. 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. Attention to detail, Critical thinking, Ability to follow protocols, Ability to maintain quality standards, planning, scheduling, data collection, Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment. Skill in the use of personal computers and related software applications. 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. While the primary job duties and responsibilities have been included, this is not designed nor meant to cover or contain a comprehensive listing of activities or responsibilities. This does not preclude the assignment of additional or developmental duties, special projects, or the scope of the position. Duties, responsibilities, and activities may temporarily or permanently change at any time with or without notice. The University of South Florida is an equal opportunity employer that does not discriminate against any employee or applicant for employment based on any characteristic protected by law. The University maintains programs for protected veterans and individuals with disabilities in accordance with all applicable federal and state laws. This job description does not constitute an employment contract.

The Clinical Research Coordinator 2 provides independent coordination of multiple, complex clinical research studies in order to ensure the efficiency and accuracy of clinical studies through all stages as the study progresses and shows vigilance in participant safety, protocol compliance, and data quality. This position may also provide guidance to other clinical research staff and support personnel. The Clinical Research Coordinator 2 evaluates, initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies, sponsors regarding study activity, as well as affiliated departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Participates, as needed, in the regulatory processes as they relate to the evaluation, initiation, maintenance, closure of studies, internal and external audits of clinical trials, and other research activity. Coordinates and oversees subject activity as it relates to the conduct of research and clinical trials. Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines and regulatory requirements. Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity. Supports department, division, and institutional goals. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards. Follows regulatory requirements, established policies, procedures and professional guidelines in planning, implementing, documenting and reporting study requirements. Responsible for maintaining study files, logs, data entry and management of databases for clinical research studies. Participates as needed in the regulatory document submissions as required by the sponsor of the trial, regulatory agencies, and TGH research policy. The coordinator is responsible for performing job duties in accordance with the mission, vision and values of the Office of Clinical Research and Tampa General Hospital. Full time presence in the office is required. Education Bachelor's degree in Science or Healthcare related field Certification Good Clinical Practice certification or completion within 3 months of hire Basic Cardiopulmonary Life Support or completion within 6 months of hire IATA Dangerous Goods or equivalent training Work Experience A minimum of three (3) years of clinical research experience, including at least 2 years specifically focused on specialty clinical research. Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas. Phlebotomy experience or completion of course work within six months of accepting the position. An equivalent combination of education and years of experience or realized competencies. Technical Knowledge, Skills, and Abilities * Intimate knowledge of advance and complex experimental design, statistics, computerized databases * Demonstrated ability to understand and implement scientific protocols * Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas * Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection * Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata RAVE, iMedra, Velos, etc) and querying. * Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated multi-disciplinary team * Exceptional attention to detail and excellent technical problem-solving skills. * Excellent organizational skills and ability to prioritize and be flexible to manage multiple tasks. * Excellent oral and written communication skills. * Intermediate proficiency in Microsoft Office. * Ability to travel between clinical sites, whenever required