Clinical research coordinator jobs in Florida - 306 jobs

Job Title: Pharmaceutical Scientist Type of Work: On-Site Schedule: Second Shift (2:00 p.m. - 11:00 p.m.) Type of Contract: Temp-to-Perm Pay Rate: Competitive - commensurate with experience and technical proficiency Department: Research & Development - Analytical & Formulation About the Opportunity A fast-growing pharmaceutical research and manufacturing organization is expanding its R&D operations in Coral Springs, FL. We are seeking motivated Scientists and Associate Scientists (Levels I & II) to support formulation and analytical development for inhalation-based drug products, including MDI, DPI, and nasal spray formulations. These are hands-on laboratory roles in a GMP-regulated environment. Successful candidates will demonstrate strong documentation skills (GDP), attention to detail, and the ability to perform and review analytical work with minimal supervision. This is an excellent opportunity to be involved in pre-formulation, formulation, analytical method development, data interpretation, troubleshooting, and continuous improvement initiatives. Key Responsibilities Perform routine and advanced analytical testing of raw materials, in-process, and finished products in compliance with GMP. Support the development of formulations (solutions, suspensions, propellant-based systems) for inhalation drug products. Operate and troubleshoot analytical instruments including HPLC, UPLC, GC, UV, and FTIR, and manage data through Empower (Waters) software. Prepare and review protocols, reports, and SOPs in alignment with quality and regulatory requirements. Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity standards. Participate in method transfer, verification, and validation activities as assigned. Support investigations of OOS/OOT, deviations, and CAPA with accurate analytical input. Collaborate cross-functionally during manufacturing trials and scale-up activities. Mentor junior scientists and contribute to the team's technical development. Maintain a safe and compliant laboratory environment in accordance with EH&S and corporate policies. Qualifications PhD, MS, or BS in Analytical Chemistry, Pharmaceutics, Pharmaceutical Sciences, Biochemistry, or related discipline. Minimum 1 year of hands-on GMP laboratory experience (academic-only exposure will not be considered). Proven hands-on experience with chromatographic systems (HPLC, UPLC, GC) and analytical testing. Working knowledge of GMP/GLP, USP, ICH, and FDA regulatory expectations. Experience with Empower software for data acquisition and reporting strongly preferred. Solid understanding of GDP and deviation processes. Preferred Attributes Prior exposure to regulated audits (FDA, EMA, MHRA) is advantageous. Experience in method validation or transfer projects a plus. Strong analytical thinking, data review, and problem-solving skills. Excellent communication and teamwork abilities. High attention to detail, organization, and quality compliance. At ttg, 'We believe in making a difference One Person at a Time,' ttg OPT.

Under direction of the Senior Manager of Clinical Trial Operations, the Clinical Research Coordinator II, CTO (CRC II) manages and conducts the day-to-day activities of a research study. In general, the CRC II ensures the study maintains accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a CRC II may include subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, collection and reviewing study data to enter it into the study and site systems, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Job Specific Duties Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol. Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance. Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's Representatives. Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff. Interacts with patients and families to recruit (screen, consent and enroll) study subjects and ensures compliance with the protocol. Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies. Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format. Demonstrates and utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows NCRIs Standard Operating Procedures, AAHRPP, HIPAA, and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines. Enters required data into CTMS. Provides new Protocols, Amendments, and study status updates to necessary research staff for digitization/entry into CTMS. Works adjusted hours to accommodate subject visits. Keeps electronic patient files and required documents up-to-date within e-regulatory system Qualifications The ideal candidate has experience with Hematology/Oncology. Minimum Job Requirements Bachelor's degree and 2 years of research experience (OR) Associate's degree and 4 years of research experience (OR) 5 years of research experience Knowledge, Skills, and Abilities Experience in pediatric clinical research in a hospital setting. Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred. Experience working on clinical trials, interventional studies is preferred Bilingual in English/Spanish. Excellent communication skills in working with both children and adults. Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change. Time management skills. Knowledge of protocols and its process. Experience with software applications including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment. Experience with relevant hospital equipment for each clinical trial project. Availability to work adjusted hours to accommodate subject visits.

The Clinical Research Coordinator is responsible for coordinating and overseeing all aspects of participant care and study execution from screening through study closeout. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and federal regulations while prioritizing participant safety, data integrity, and high-quality patient care. Key Responsibilities Coordinate all aspects of participant care from screening through study completion in accordance with the study protocol and Principal Investigator (PI) delegation. Ensure the informed consent process is conducted and documented in compliance with federal regulations (45 CFR Part 46). Maintain accurate and up-to-date source documentation, including medical history collection, eligibility assessments, and documentation of all study-related procedures. Promptly identify, document, and report adverse events, protocol deviations, and unanticipated problems to the PI, sponsor, and IRB in accordance with 21 CFR Part 312. Provide individualized, protocol-based education to study participants regarding informed consent, study requirements, investigational product (IP) use, safety considerations, potential side effects, and participant rights. Facilitate timely and accurate communication of participant information with the PI and research team to support study conduct and patient safety. Maintain strict adherence to HIPAA regulations and protect participant confidentiality at all times. Dispense, administer, and educate participants on the proper use of investigational products in accordance with the protocol, scope of practice, and PI direction. Collaborate closely with the clinical team and external clinical partners to support trial implementation and ensure protocol compliance. Perform accurate and timely data collection, source documentation, and data entry into sponsor Case Report Forms (CRFs), Interactive Web Response Systems (IWRS), and databases. Resolve data queries and sponsor requests promptly. Assist with long-term storage and maintenance of research records in accordance with contractual and regulatory requirements. Prepare for and participate in site initiation visits, monitoring visits, audits, and regulatory inspections. Maintain Essential Documents and the Trial Master File (TMF), ensuring regulatory compliance and audit readiness, including FDA Form 1572, financial disclosures, IRB documentation, delegation of authority logs, monitoring reports, and enrollment logs. Support coordination with internal and external stakeholders, including sponsors and CROs, to facilitate study start-up, patient recruitment, enrollment goals, and trial execution. Promote a patient-centered research culture that emphasizes safety, quality, and ethical conduct. Manage participant stipend payments, including system registration and ongoing payment processing in accordance with company policies. Adhere to company research quality assurance standards and operating procedures. Travel as required to investigator meetings, sponsor meetings, and between facilities or practices within the community. Maintain current knowledge of clinical research regulations and standards, including GCP, FDA regulations, HIPAA, and IATA shipping requirements, and maintain required licensures and certifications. Provide training and oversight to Clinical Research Coordinators and/or Research Assistants as assigned. Actively promote GUEST customer service standards and foster effective working relationships across all levels of the organization. Participate in team initiatives, staff meetings, and perform duties in accordance with company policies and procedures. Maintain regular and reliable attendance.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is “inspection ready” contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

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

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

The Department of Internal Medicine is the largest and most complex Department in the Morsani College of Medicine with over 26 Divisions, Programs and Centers/Institutes, total human resources in excess of 1,000, and an annual all-source budget in excess of $143,000,000. The Department's ongoing growth includes the restructure of Cardiovascular Sciences from a separate Department to a Division, support of the microbiome initiative, and the execution of clinical, research and education initiatives focused on COVID-19 and emerging infectious diseases. The mission of the Department is to rank among the elite in the nation in the areas of education, research and patient care. The Department provides education and training for a diverse group of medical students, residents, fellows and health personnel from USF and throughout the world. The Department's research activities are numerous and involve both basic and clinical research activities in all subspecialties of Internal Medicine. Our NIH funding is in excess of $120 million over the past 3 years. Patient care occurs in our affiliated hospitals (including Tampa General Hospital, H Lee Moffitt Cancer Center and Research Institute, James A Haley VA Hospital, Florida Hospital) as well as our state-of-the-art ambulatory health care centers. The Department also provides healthcare support and services via contractual arrangements with many diverse organizations. The US News & World Report recent rankings of our subspecialties include Nephrology at 18, and Gastroenterology at 24 and Primary Care at 67. The Department's faculty represent a group of dedicated physicians that are well-recognized as leaders in all three mission areas. Minimum Qualifications: Master's Degree. 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. Special Skills: Strong working knowledge in Microsoft Office Programs. Bilingual - Spanish. Experience in Cardiology or Pulmonary Specific Clinical Research, medical and research terminology, health care setting processes and procedures, phlebotomy experience, ECG training and training in other clinical procedures, and general knowledge of infection control procedures. Florida Nursing credentials. Clinical Research Certification/Training from reputable agency. The Clinical Research Associate (CRA) will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research.

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

Summary: The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress. Duties and Responsibilities: The Clinical Research Coordinator: Performs study subject. Screens and recruits' subjects. Doses and administers study drugs and/or implements study methodologies. Accounts for study drugs. Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators. Accounts for study drugs. Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators. Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial. Enters patient and research data in systems designated by the company. Maintains patient charts and resolves research queries. Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements. Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms. Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals. Oversees subject enrollment to ensure that informed consent is properly obtained and documented. Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups. Creates source documents as assigned, such as regarding protocols, memos, patient participation. Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures. Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings. Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research. Orders drugs or devices necessary for study completion. Documents findings and events in the Company's research CTMS platform and in other binders and platforms as directed. Occasional travel to Company sites, Principal Meetings, and/or Company meetings. Performs other duties as assigned. This is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time. Requirements: Minimum high school diploma required. Bachelor's degree in Life Sciences, Nursing, or a related field preferred) Bilingual English/ Spanish required Knowledge of clinical trial management software and electronic data capture systems required 2+ Years of previous CRC experience required Nephrology experience a plus but not required Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH) required Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus but not required Enthusiasm for clinical research and a desire to learn required Competency Requirements: Strong organizational and time management skills. Excellent attention to detail and ability to maintain accurate records. Effective communication skills, both written and verbal. Ability to work independently and collaboratively in a team environment. Proactive problem-solving skills and adaptability in a dynamic setting. Physical Requirements and/or environmental factors: Prolonged periods of sitting at a desk and working on a computer Must be able to lift 20 pounds at a time. Travel to sponsor required meetings as needed. Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

Job DescriptionMedical Research Coordinator (Full Time) - Hollywood, FL (Spanish-speaker) We are looking for an experienced, bilingual (Spanish-speaking) Medical Research Coordinator to join our research team in Hollywood, FL. The Medical Research Coordinator will be responsible for the coordination of clinical research studies while ensuring compliance with all applicable regulations and guidelines. The ideal candidate will possess a strong understanding of clinical research, clinical trials, and the medical field. The Medical Research Coordinator should have excellent communication, organizational, and problem-solving skills with an ability to prioritize tasks effectively. Responsibilities Develop and maintain clinical study documents and coordinate all aspects of clinical trials including case report forms, informed consents, and other regulatory documents. Monitor clinical trials and ensure that they are conducted in accordance with protocols, standard operating procedures, and applicable regulations. Train, support and delegate tasks to clinical research staff. Conduct data review and analysis. Develop and manage budgets, timelines, and communications. Ensure compliance with all applicable federal, state, and local regulations. Maintain accurate records of research activities and submit reports to the appropriate authorities. Develop and implement strategies for data collection. Work with study investigators to ensure that the study is conducted in compliance with the protocol. Develop study-related materials and provide support to investigators. Provide guidance to investigators on the interpretation and implementation of the protocol. Coordinate and participate in monitoring visits. Perform other duties as assigned. Requirements Healthcare related background, such as FMD (Foreign Medical Doctor) NP, LPN, or RN. At least two years of experience as a Clinical Research Coordinator. Proficient in Spanish. Excellent communication, organizational, and problem-solving skills. Ability to prioritize tasks effectively. Ability to work independently and as part of a team. Ability to work in a fast-paced environment. Knowledge of applicable federal and state regulations. Knowledge of clinical research processes and procedures. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, etc.). If you are an experienced Medical Research Coordinator who is looking for a new opportunity in Hollywood, FL, we encourage you to apply today! The HealthPlus Team

To work as an integral member of the Rovia/Investigator site staff, maintaining the day-to-day operations and assist in the development of the Rovia network. This includes planning, coordinating, and executing clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and Rovia SOPs and any relevant local guidelines and regulations. Duties/Responsibilities: Manages site selection visits and coordinates study startup activities (e.g., Source Data ID log, recruitment plan, site blinding plan, and temperature log). Oversees facility issues in collaboration with the Site Manager and Director, and leads weekly site meetings. Manages investigator signature processes and supports study recruitment and contingency planning. Monitors and tracks pre-screening, enrollment efforts, and progress toward study enrollment goals, addressing delays or changes promptly. Identifies difficult-to-enroll studies and collaborates with the recruitment manager to improve enrollment. Ensures timely data entry in EDC and Clinical Conductor platforms and resolves any issues. Leads or attends study initiation, interim monitor, and close-out visits. Reviews site monitor reports, follows up on action items, and conducts quality checks on subject visits. Collaborates with site managers and compliance teams to identify and address quality issues. Works with the Source Document Specialist to ensure source documents are ready for patient visits. Provides support and guidance to site research staff, including training, troubleshooting, and resource management. Acts as a liaison between the site, financial team, and management, and suggests improvements to workflows. Develops and maintains investigator relationships, providing regular progress reports. Onboards and trains new staff, tracks their progress, and addresses gaps in training. Participates in site staff evaluations and new employee interviews. Serves as a mentor and fosters a positive work environment. Conducts presentations at company training events and collaborates on external relationships for specialized study protocols. Supports special projects, business development, team building, and writing SOPs. Perform other duties as assigned. Required Skills/Abilities: Sound knowledge of medical terminology. Sound knowledge of ICH/GCP and Regulatory requirements. Excellent interpersonal and organizational skills. Proficient in the use of Microsoft Office and Excel. Fluent in spoken and written English. Ability to work independently and in a team environment. Ability to maintain confidentiality. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Education/Experience: High school diploma required, bachelor's degree in related field of study preferred. Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or within 6 months of role acceptance. 3+ years of CRC experience preferred, preferably working on industry-sponsored trials. License/Certification status with appropriate CEUs, if applicable. Current cardiopulmonary resuscitation (CPR) certification. Current International Air Transport Association (IATA) certification. Current Good Clinical Practice (GCP) certification.

Job Description Job Type: Full-time, non-exempt Reports to: Executive Director, Head of Site Operations Join Us at Civia Health At Civia Health, our Clinical Research Coordinators are essential to deliver trials that are efficient, ethical, and patient-centered. We're seeking an organized and motivated CRC who thrives in a fast-paced, collaborative research setting. You'll be the primary point of contact for participants and ensure that trials are conducted with precision and care. This position offers the opportunity to work in a technology-enabled research environment utilizing electronic source documentation (eSource), eConsent, electronic Investigator Site Files (eISF), and other digital tools to streamline trial conduct. The CRC will also have the opportunity to provide occasional on-site support at partner locations as needed. At Civia Health, you're not just taking a job: You're joining a mission to transform the way clinical research is done. Our purpose is bold: to bring clinical trials front and center in your community, make them accessible to everyday people, and empower underrepresented communities to participate. We're reinventing how clinical studies are run, delivering valid, scalable evidence with a consumer-first mindset. Too often, trials are expensive, fragmented, and overlook the experience of the participant. At Civia, we're changing that. Our leadership team are experienced industry leading, visionary professionals who know what's broken - and how to fix it. We treat participants like valued partners, not research subjects. That means supporting their agency, putting their needs, comfort, and enjoyment first - and rewarding them generously for their time and effort. What It Means to Work at Civia Every team member plays a crucial role in reshaping clinical research. You'll help make studies more human-centered, inclusive, and efficient. We're looking for people who are driven by purpose, inspired by innovation, and ready to roll up their sleeves to do meaningful work. At Civia, your contributions aren't just transactional, they're transformational. What You'll Do Clinical Trial Coordination • Coordinate and manage all aspects of assigned Phase 2-4 clinical trials from site initiation to close-out. • Conduct study visits, including obtaining informed consent, performing protocol-required procedures, and collecting source data using eSource systems. • Ensure timely and accurate entry of study data into electronic case report forms (eCRFs). Technology & Documentation • Utilize eSource, eConsent, eISF, and other clinical trial software platforms to maintain complete, accurate, and regulatory-compliant study records. • Support site readiness and compliance with 21 CFR Part 11, ICH GCP, and sponsor SOPs. Regulatory Compliance • Maintain up-to-date regulatory documents and study binders (electronic and/or paper as required). • Assist with preparation for sponsor, CRO, or regulatory audits. Patient Engagement & Safety • Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria. • Ensure ongoing patient safety by monitoring for adverse events and reporting per protocol. Collaboration & Support • Serve as the primary point of contact for sponsors, CROs, monitors, and other site staff. Support training and mentoring of new CRC staff as assigned. • Provide on-site support at additional study locations when required (occasional travel). • Occasional travel may be required for audits, site visits, or team meetings. What You Bring Bachelor's degree in health sciences, nursing, or related field (or equivalent experience). Willingness to travel occasionally to other sites for study support. Strong interpersonal skills for effective collaboration with patients, investigators, and sponsors. Excellent organizational skills, attention to detail, and ability to prioritize multiple studies. Proficient in Microsoft Office Suite and clinical trial management systems (CTMS). Experience with eSource, eConsent, and electronic ISF systems strongly preferred. Minimum 3 years of experience coordinating Phase 2-4 clinical trials in a site, SMO, or academic research setting. Certified Clinical Research Coordinator (CCRC) a plus. Knowledge of GCP, FDA regulations, and clinical trial conduct. What We Offer Competitive compensation Medical, dental, and vision insurance Generous PTO and paid holidays Flexible scheduling options Professional development and continuing education support A mission-driven team that values respect, inclusion, and innovation Ready to Make an Impact? Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact. Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who've seen what needs to change. People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work. Invested in Your Growth: We don't just hire for today; we're building the leaders and changemakers of tomorrow. If you're ready to be part of something meaningful-and work with people who care deeply about doing good work-apply today by submitting your resume and cover letter to the link above. We're excited to learn more about you! Powered by JazzHR Q359SHqd1B

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

Job Description Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Clinical Research Coordinators at our Jacksonville, FL location! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday - Friday, 7 AM - 4 PM - hours may vary Location: 4085 University Blvd. South Suite 1 Jacksonville, FL 32216 Compensation: Competitive hourly base compensation Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management. QUALIFICATIONS Bachelor's degree preferred, but not required Phlebotomy experience is required, EKG or other patient labs/processes preferred Preferably 2+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Powered by JazzHR br5zEZBk0O

Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree required; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.

Job DescriptionBenefits: Competitive salary Dental insurance Health insurance Opportunity for advancement Paid time off Vision insurance Clinical Research Coordinator West Palm Beach, FL Metabolic Research Institute (MRI) is seeking an experienced Clinical Research Coordinator to join our dynamic and growing team. We are a respected private clinical research organization dedicated to advancing science and improving lives through innovative studies in diabetes and metabolic health. What Youll Do Coordinate and manage all aspects of Phase IIIV clinical trials Work directly with investigators, sponsors, and participants Ensure studies are conducted efficiently and in full compliance with protocols Collect, document, and manage clinical data accurately and on schedule What We Offer Competitive salary and benefits Excellent work environment with a supportive, experienced team Opportunities for professional growth and advancement Convenient West Palm Beach location in a modern research facility Qualifications Clinical Research Coordinator experience is a must Knowledge of diabetes and metabolic studies preferred Proficiency with EDC systems, Microsoft Office, IVRS/IWRS Experience with ECG, vital signs, and patient interaction Strong organization and multitasking skills Professional communication and appearance Bilingual (English/Spanish) a plus Join us and be part of a research organization that values integrity, innovation, and collaboration. Job Type: Full-time Pay: $26$28 per hour (commensurate with experience) Apply today to grow your career with a team dedicated to advancing medical discovery.

Cancer Specialists of North Florida is recruiting a Clinical Research Coordinator - Float for our busy Specialty Practice . The Clinical Research Coordinator (CRC) Float will facilitate timely coordination of daily clinical trial activities across multiple research projects and ensure trial protocol compliance. The CRC is responsible for recruitment, screening, consenting, enrollment, and clinical documentation of patients in clinical trials as well as ensuring protocol compliance. The CRC will provide education to patients and staff about trial concepts and requirements for participation. The CRC will work collaboratively with the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure execution of the clinical trial in accordance with the trial protocol, Food and Drug Administration (FDA), Good Clinical Practice (GCP) guidelines, and applicable state and local regulations. In addition to this, the CRC assists the research team, physicians and manager with any additional projects requested. Essential duties and responsibilities include the following: Review and develop a familiarity with trial protocol including but not limited to study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protection Serve as a resource and “expert” for clinical staff and patients regarding clinical trial questions Ensure compliance with research protocols by providing ongoing quality control audits Provides CRC coverage to all CSNF clinics as assigned by manager or team lead. Strong interpersonal and communication skills to effectively collaborate with clinic site staff and research staff. Recruit and screen potential study participants and perform intake assessments for assigned clinical trials in accordance with trial protocol Obtain informed consent in accordance to the Code of Federal Regulations (45 CFR part 46) Coordinate all study visits and assist treating physician with completion of trial activities including but not limited to: schedule participant visits, coordinate participant travel and meals, participant dosing and observation, scheduling and other evaluations, adverse event monitoring, vitals collection, and IVRS management Collect, process, and ship specimens Collaborate with the research pharmacist to perform drug accountability, compliance, and dosing Educate clinical staff regarding study drug administration requirements, including required pre-medications, order of administration, monitoring time points, and the need for infusion start/stop times All other duties as assigned. Full Time M-F position Education and Experience: Bachelor's degree in science or health related field; BSN, PharmD, MD, or PhD preferred 2+ years of work as a clinical research coordinator in an oncology setting Compensation and Benefits: Salary is commensurate with experience and qualifications. Cancer Specialists of North Florida is an "EEO Employer” and “Drug Free Workplace”

Job DescriptionSalary: The Experienced Clinical Research Coordinator (CRC) will support the Clinical team in their efforts to achieve daily and overall company goals. Work as an integral member of Hillcrest Medical Research Site staff, maintaining the day-to-day relationship with patients and assisting in developing the HMR network. This includes planning, coordinating, and, as appropriate, the execution of clinical studies according to the protocol, contracted scope of work, sponsor, CRO, and HMR SOPs and any relevant guidelines regulations. Essential Functions & Responsibilities: Duties include but not limited to: Work directly at the patient\subject interface at the research site to deliver high-quality patient data according to local regulations, agreed scope of work, and as required by the protocol. Attend and participate in an investigator meeting, monitoring visits, audits, seminars, and other regions on national meetings. Assist with pre-screening, screening, and enrollment of subjects into assigned studies. Support subjects on trial to ensure a positive patient experience. Assist with the establishment of a recruitment and contingency plan for each study Perform function necessary for successful completion of all protocol required visits\procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of the investigational product, scheduling, drug accountability\reconciliation, and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements. Accurately complete source documents and case report forms in both paper and electronic format. Assist investigators with recording and reporting of adverse events and SAE as per local regulatory authority guidelines. Assist in the clinical, operational efforts of the team between HMR clinical research sites. Perform all training modules required by HMR SOP in a timely and effective matter. Source document completion and Data Entry Study and visit Preparedness & Monitor visit preparation Patient scheduling assistance and recruitment, as needed Accept direction and constructive criticism from supervisors and managers in compliance with Hillcrest Medical Research policies and procedures. Skills & Abilities: Sound knowledge of medical terminology Sound knowledge of IHC\GCP and regulatory requirements Ability to work independently and as part of a team while under pressure without supervision Excellent interpersonal and organizational skills Ability to organize and prioritize work and responsibilities Strong interpersonal skills creating and maintaining a positive dialogue with sponsors/CROs, clients, and colleagues Ability to maintain confidentiality Excellent attention to detail Strong quantitative, research, and data analytic skills Proficiency in Microsoft Office Suite Education & Experience: MA, LPN, RN, CNA, EMT, Paramedic or equivalent or higher preferred. Phlebotomy Certification preferred. At least 2 Years of experience as a Clinical Research Coordinator Hillcrest Medical Research is an equal opportunity employer. Decisions of employment are made based on business needs, job requirements and applicants qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. Hillcrest Medical Research is a drug-free work place and all offers of employment are contingent upon passing a pre-employment drug screen.

We are excited that you are considering joining Nova Southeastern University! Nova Southeastern University (NSU) was founded in 1964, and is a not-for-profit, independent university with a reputation for academic excellence and innovation. Nova Southeastern University offers competitive salaries, a comprehensive benefits package including tuition waiver, retirement plan, excellent medical and dental plans and much more. NSU cares about the health and welfare of its students, faculty, staff, and campus visitors and is a tobacco-free university. We appreciate your support in making NSU the preeminent place to live, work, study and grow. Thank you for your interest in a career with Nova Southeastern University. Primary Purpose: Supports collaborative and innovative clinical research efforts. This position is contingent on the availability and continuation of external-funding and/or contract. As such, any offer of employment may be withdrawn or employment ended in the event the external funding and/or contract ceases or is reduced. Job Category: Exempt Hiring Range: Pay Basis: Annually Subject to Grant Funding? Yes Essential Job Functions: 1. Participates in preparation and management of research budgets and monetary disbursements. 2. Arranges for research study sites and determines staff or equipment availability. 3. Confers with health care professionals to determine the best recruitment practices for studies. 4. Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. 5. Informs patients or caregivers about study aspects and outcomes to be expected. 6. Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols. 7. Oversees subject enrollment to ensure that informed consent is properly obtained and documented. 8. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts. 9. Contacts outside health care providers and communicates with subjects to obtain follow-up information. 10. Performs other duties as assigned or required. Job Requirements: Required Knowledge, Skills, & Abilities: Knowledge: 1. English Language - General knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. 2. Medicine and Dentistry - General knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventative health-care measures. 3. Mathematics - General knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications. Skills: 1. Active Listening - Basic skills in giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times. 2. Coordination - Basic skills in adjusting actions in relation to others' actions. 3. Reading Comprehension - Basic understanding of written sentences and paragraphs in work-related documents. 4. Writing - Basic skills in communicating effectively in writing as appropriate for the needs of the audience. 5. Speaking - Basic skills in talking to others to convey information effectively. 6. Critical Thinking - Basic skills in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. 7. Judgment and Decision Making - Basic skills in considering the relative costs and benefits of potential actions to choose the appropriate one. 8. Monitoring - Basic skills in monitoring / assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. 9. Time Management - Basic skills in managing one's own time and the time of others. Abilities: 1. Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences. 2. Oral Expression - The ability to communicate information and ideas in speaking so others will understand. 3. Written Comprehension - The ability to read and understand information and ideas in writing so others will understand. 4. Written Expression - The ability to communicate information and ideas in writing so others will understand. 5. Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense. 6. Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (including finding a relationship among seemingly unrelated events). 7. Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem. Physical Requirements: 1. Near Vision - Must be able to see details at close range (within a few feet of the observer). 2. Speech Clarity - Must be able to speak clearly so others can understand you. 3. Speech Recognition - Must be able to identify and understand the speech of another person. 4. May be exposed to short, intermittent, and/or prolonged periods of sitting and/or standing in performance of job duties. 5. May be required to accomplish job duties using various types of equipment/supplies, to include but not limited to pens, pencils, and computer keyboards. Required Certifications/Licensures: Required Education: Bachelor's Degree Major (if required: Biology, Nursing, or related discipline Required Experience: Two (2) or more years of related relevant research experience. Preferred Qualifications: Is this a safety sensitive position? No Background Screening Required? Yes Pre-Employment Conditions: Sensitivity Disclaimer: Nova Southeastern University is in full compliance with the Americans with Disabilities Act (ADA) and does not discriminate with regard to applicants or employees with disabilities and will make reasonable accommodation when necessary. NSU considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status or any other legally protected status.