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  • Senior Clinical Research Coordinator - Plant City, Florida

    Denali Health 3.8company rating

    Clinical research coordinator job in Plant City, FL

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

    Actalent

    Clinical research coordinator job in Miami, FL

    Job Title: Lead Clinical Research CoordinatorJob Description The Lead Clinical Research Coordinator will work under the direction of a Research Clinical Trial Operations leader to independently manage and oversee multiple clinical studies within the Clinical Trials Office. This role requires advanced-level knowledge and skills in coordinating clinical research involving human subjects. The successful candidate will ensure that studies are conducted smoothly and in compliance with protocol requirements, avoiding delays or errors in patient registration, enrollment, and documentation. Key responsibilities include subject recruitment, data management, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, and regulatory authorities. Additionally, the Lead Clinical Research Coordinator will provide guidance, training, and mentorship to Clinical Research Coordinators, Research Assistants, and other support personnel. Responsibilities Serve as a subject-matter expert and resource for the research team on the compliant conduct of assigned studies. Facilitate communication between investigators and Clinical Research Coordinators on subject-matter or technical matters. Oversee study conduct, including support data collection for study start-up activities. Manage the collection, maintenance, and reporting of accurate patient data for submissions to sponsors and coordinate specimen collections and shipments as required by protocol. Review and confirm subject study eligibility with PI/Sub-I of assigned studies. Oversee study registration, patient screening/enrollment, and overall study requirements. Register and enroll research participants. Aggregate, track, trend, and report research study and patient screening/enrollment data as required. Interact with patients and families to recruit, screen, consent, and enroll study subjects while ensuring compliance with the protocol. Comply with Research Finance Compliance policies and procedures, including time and effort reporting for grants. Submit protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notify CTMS support staff for protocol digitization. Enter Research Patient information into CTMS within 72 hours of enrollment, patient visit, or patient-related event. Pre-screen potential research participants and enter information into CTMS within real-time (if possible) or within 24 hours. Compile accurate CTMS metrics data for updating SAC CTO slides and run weekly enrollment reports for management review. Update study statuses in CTMS and ensure study enrollment changes are communicated to the Research Regulatory Affairs team and CTO Management. Attend meetings with Research management, the research team, and/or PI/Sub-Is and be prepared to discuss research portfolio and/or patient status. Essential Skills Clinical research expertise Pre-screening patients Compliance and consenting Leading and running trials Additional Skills & Qualifications Bachelor's degree or higher and 4.8 years of research experience, or 9 years of research experience Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position Bilingual in English/Spanish is highly preferred Work Environment The role involves working primarily in a hospital setting (80%) with some work in a corporate office environment (20%). Job Type & Location This is a Contract to Hire position based out of Miami, FL. Pay and Benefits The pay range for this position is $35.00 - $37.00/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 Miami,FL. Application Deadline This position is anticipated to close on Jan 30, 2026. 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.
    $35-37 hourly 5d ago
  • Lead Clinical Research Coordinator - 249543

    Medix™ 4.5company rating

    Clinical research coordinator job in Miami, FL

    Lead Clinical Research Coordinator Opportunity in Miami, FL (33155) The Clinical Research Coordinator plays an integral role in supporting the day-to-day operations of clinical trials at the investigator site. This position is responsible for planning, coordinating, and executing clinical studies in compliance with study protocols, contracted scope of work, ICH/GCP guidelines, sponsor and CRO requirements, and applicable local regulations. Duties/Responsibilities Coordinate study startup activities, including site selection visits, source documentation setup, recruitment planning, and site preparation. Lead weekly site meetings and collaborate with site leadership to address facility and operational needs. Manage investigator signature processes and support subject recruitment, enrollment, and contingency planning. Monitor and track screening, enrollment, and study milestones, identifying barriers and implementing solutions. Partner with recruitment teams to improve enrollment for difficult-to-fill studies. Ensure timely and accurate data entry in EDC and clinical trial management systems, addressing discrepancies as needed. Participate in study initiation, monitoring, and close-out visits, including reviewing monitor reports and following up on action items. Conduct quality checks on subject visits and collaborate with compliance teams to address issues. Work with source documentation staff to ensure readiness for patient visits. Provide training, mentorship, and troubleshooting support to site staff; assist with onboarding new employees and evaluating training progress. Act as a liaison between site operations, financial teams, and leadership to improve workflows and communication. Develop and maintain strong investigator and sponsor relationships while providing progress updates. Participate in staff evaluations, candidate interviews, and employee development activities. Deliver presentations at training events and contribute to external collaborations for specialized study protocols. Support SOP development, special projects, business development initiatives, and team-building activities. Perform other duties as assigned. Required Skills/Abilities Strong knowledge of medical terminology, ICH/GCP, and regulatory requirements. Excellent interpersonal, communication, and organizational skills. Proficiency with Microsoft Office, including Excel. Bilingual in English and Spanish, with strong written and verbal skills. Ability to work independently and collaboratively within a team. Strong problem-solving skills with the ability to maintain confidentiality and build effective working relationships. Education/Experience Bachelor's Degree Required Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or willingness to obtain within 6 months of hire. Minimum 5 years of clinical research coordinator experience, preferably with industry-sponsored trials. Additional Details Location: Miami, FL (33155) Position: Lead Clinical Research Coordinator Employment/Length of Assignment: Contracted position with the potential to be brought on permanent Hours: Monday-Friday; 8:30AM-5PM; Onsite 5 Days a Week Pay Range: $72,000-$95,000 Annual Salary (Dependent on background and years of experience) Requirements: 5+ Years of Clinical Research Coordinating Experience; Bachelor's Degree Required
    $72k-95k yearly 22h ago
  • Clin Research Nurse II AES

    Adecco Us, Inc. 4.3company rating

    Clinical research coordinator job in Ocala, FL

    Adecco Healthcare & Life Sciences is hiring a Clinical Research Nurse for our Medical Supply and Instrumentation Partner in Ocala, FL. The anticipated hourly wage for this position is between $39 and $40.24. Hourly wage may depend upon experience, education, geographic location, and other factors. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria Summarized Purpose: Acts as a Lead Coordinator in a site setting whereby they may be leading logistics, vendor/stakeholder management, answer complex protocol and Alzheimer's questions. Oversee multiple ongoing clinical trials involving patients. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants. Essential Functions: - Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. - Provides medical care to patients, always ensuring patient safety comes first. - Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized. - Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). - Records all patient information and results from tests as per protocol on required forms. - Where required, may complete IP accountability logs and associated information. - Reports suspected non-compliance to relevant site staff. - Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. - Promotes the company and builds a positive relationship with patients to ensure retention. - Attends site initiation meetings and all other relevant meetings to receive training on protocol. - May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results. - Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. - Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded. - Adheres to company COP/SCOP. - May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. Education and Experience: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field - Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Knowledge, Skills and Abilities: - Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) - Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving - Demonstrated ability to exercise discretion and sound judgement - Good decision-making, negotiation and influencing skills - Good communication skills and English fluency will be an advantage - Good organizational skills - Good proficiency in basic computer applications - Good interpersonal skills to work in a team environment **Comments** Monday-Friday 9-5 **Pay Details:** $39.00 to $40.24 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ********************************************** The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance **Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
    $39-40.2 hourly 6d ago
  • Clinical Improvement Coordinator

    Adventhealth 4.7company rating

    Clinical research coordinator job in Tavares, FL

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 1000 WATERMAN WAY **City:** TAVARES **State:** Florida **Postal Code:** 32778 **Job Description:** **GENERAL SUMMARY:** The Clinical Improvement Coordinator is responsible for monitoring and impacting improvement in patient satisfaction. The Clinical Improvement Coordinator rounds on the care team and patients, monitors comments received, analyzes patient satisfaction survey scores, and facilitates patient experience training/presentations. Identifies opportunities for improving care or preventing events that have a negative impact on patient care. **PRINCIPAL DUTIES AND JOB RESPONSIBILITIES** **:** + Rounds on care team on a daily basis to observe quality of care delivered to patients and family and provides coaching/feedback to care team. + Rounds on patients on a daily basis to discuss the quality of care they are receiving and provides feedback to care team staff and nurse manager. + Works closely and communicates with clinical leaders from inpatient nursing, the Emergency Department and Surgical Services. + Facilitates use of survey data to develop proactive measures to improve patient satisfaction. + Is responsible for preparation of timely and accurate reports of data collected for the review activities listed above for presentation to members of the Medical Staff, Medical Staff committees, hospital committees, and/or Administration. + Creates and completes data reports for leaders on a weekly, monthly, and ad hoc basis to include, but not limited to: HCAHPS, ED CAHPS, and OAS CAHPS detail reports. + Monitors the above outcomes on a monthly basis and reports analyzed trends to leaders for monthly Pier Review Committees including action plans. + Presenter/educator for patient experience training/presentations involving entry level, clinical, and physician team members. + Oversees training and education schedule for AdventHealth Waterman Patient Experience. Manages educational requests received. + Completes and submits Origami to Risk Management for any grievances that may be received from time to time. + Performs other related duties as assigned or requested. **Knowledge, Skills, and Abilities:** - Computer skills with a proficiency in Microsoft Office and must be adaptable to new software programs. [Required] - Strong interpersonal skills [Required] **Education:** - Bachelor's of Nursing [Preferred] **Field of Study:** - Graduate of an approved school of nursing Required **Work Experience:** - 3+ years of clinical experience [Required] **Additional Information:** - N/A **Licenses and Certifications:** - Registered Nurse (RN) [Required] - Basic Life Support - CPR Cert (BLS) [Required] - Advanced Cardiac Life Support Cert (ACLS) [Required] **Physical Requirements:** _(Please click the link below to view work requirements)_ Physical Requirements - **************************** **Pay Range:** $31.82 - $59.17 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Risk Management, Quality, & Clinical Effectiveness **Organization:** AdventHealth Waterman **Schedule:** Full time **Shift:** Day **Req ID:** 150761848
    $31.8-59.2 hourly 2d ago
  • Clinical Research Associate

    Summit Therapeutics Sub, Inc.

    Clinical research coordinator job in Miami, FL

    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.
    $97k-114k yearly Easy Apply 1d ago
  • Senior Clinical Research Coordinator

    Gastro Health 4.5company rating

    Clinical research coordinator job in Pensacola, FL

    Gastro Health, LLC is a leading medical group made up of physicians and advanced practitioners specializing in the treatment of gastrointestinal disorders, nutrition, and digestive health. Our research division provides patient access to Phase I-IV clinical research initiatives relational to Gastroenterology and Hepatology throughout the world. Our mission is to provide outstanding medical care and an exceptional healthcare experience. Gastro Health is built on our Core Values of Compassion, Collaboration, Integrity, Empowerment, Accountability, Continuous Improvement, and Positive Attitude. Job Summary: Due to our rapid growth, we are currently seeking an industry professional to join our research team. This vital role will work directly with subjects, under the direct supervision of the Principal Investigator (PI). This role will be responsible for performing and implementing all aspects of clinical research trials, ensuring protocol-specific and regulatory compliance. Responsibilities: Coordinate and participate in site preparation for Site Initiation Visits, interim Monitoring Visits, Investigator Meetings, and Close-Out visits Ensure the safety and well-being of all study-related subjects throughout the course of their study participation Work closely with the PI to ensure compliance with protocols, and successfully conduct all assigned study-related activities in accordance with FDA and ICH GCP guidelines Ensure Standard Operating Procedures are enforced and followed with strict adherence to company policy Assure IRB approvals are obtained prior to initiating any study-related activities Recruit and track subjects with expectations for target enrollment goals Current proficiency with conducting phlebotomy Consent subjects in accordance with FDA, GCP and protocol guidelines Ensure adequate understanding of inclusion and exclusion criteria for each protocol Accurately record and communicate all adverse events (AEs) to the PI and monitor in a timely manner Record all concomitant medications and medical/surgical history accurately for each subject Schedule all subject visits within study timelines identified within the protocols Ensure subject safety and communicate safety data in a timely manner with the PI Collect and accurately record study data in source documents and case report forms Design and maintain organizational tools to conduct study activity accurately and in compliance with GCP, FDA and protocol guidelines Complete all paperwork as required by sponsor and CRA in a timely manner Why Work With Gastro Health? When you join Gastro Health, you become part of a team dedicated to supporting clinical research and discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing diseases. Gastro Health, LLC employs the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees, which includes: Health, Dental, Vision, Paid Time Off, Life insurance, 401k, Profit Sharing Plan, Short & Long-term disability, HSA, FSA and Corporate Holidays Qualifications: Bachelor's Degree, preferred Availability to travel as required for training sessions 3-5 years of Clinical Research experience required Prior knowledge of clinical trials, as well as ICH-GCP principles, preferred Self-starter capable of working independently Ability to thrive in a fast-paced, high-pressure environment Desire to train and develop skills Exceptional written and oral communication skills BLS certification, preferred Familiarity with medical terminology Knowledge of how to operate/conduct and ECG/EKG Machine Skills in Phlebotomy/Venipuncture Ability to provide shadow support to entry-level research personnel Certification via SOCRA and/or ACRP Facilitation of Close-Out, Site Initiation, and Monitoring visits as required/needed Knowledge of Protocol Deviations, Serious Adverse Events, and Safety Reports 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR (AllScripts)
    $64k-82k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate (Start Up) - Cross TA - Miami

    Icon Plc 4.8company rating

    Clinical research coordinator job in Florida

    Clinical Research Associate (Start Up) - Cross TA - Miami, FL ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What will you be doing? * Works on multiple trials within the Cross Therapeutic areas - Start up focus * Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. * Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. * Build strong relationships with site personnel to facilitate a smooth onboarding process. * Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). * Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. * Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. * Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. * Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. * Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. * Proactively identify and address any issues that may delay study initiation or affect trial deliverables. * Maintain precise documentation to ensure readiness for inspections. * Support sites during the activation phase until they achieve "Green Light" status for site opening. * Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. * Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? * Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences * Must be located in Miami, FL ; near a major airport. * Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials * Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials * Knowledge of several therapeutic areas * Analytical/risk-based monitoring experience is an asset * Ability to actively drive patient recruitment strategies at assigned sites * Ability to partner closely with investigator and site staff to meet all of our study timelines * Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). * Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. * Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. * To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $46k-66k yearly est. 5d ago
  • Research Associate 3, Oncology Clinical Trials, FT, 8:00A - 4:30P

    Baptist Health South Florida 4.5company rating

    Clinical research coordinator job in Miami, FL

    Responsible for collecting, analyzing and interpreting collected data. The Research Associate 3 will adhere to Baptist Health South Florida (BHSF) guidelines when presenting research outcomes and ensure that the highest quality of research is performed. The estimated salary range for this position is $58494.88 - $76043.34 / year depending on experience. Degrees: * Masters Degree is required. Licenses & Certifications: * Collab Inst Training Init. Additional Qualifications: * CITI certification required within 30 days of hire. * While a Master's degree of Science is a minimum requirement, candidates with PhD and MD degrees (especially those who completed their residency programs) are preferred. * Candidates must be highly organized with strong analytical, research, math and statistical skills as well has had previous experience working in an academic and/or scientific setting. Minimum Required Experience: 5 Years
    $58.5k-76k yearly 60d+ ago
  • Clinical Research Associate (Start Up) - Cross TA - Miami

    Icon Central Laboratories

    Clinical research coordinator job in Miami, FL

    Clinical Research Associate (Start Up) - Cross TA - Miami, FL ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Miami, FL ; near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $48k-76k yearly est. Auto-Apply 6d ago
  • Clinical Research Associate (Start Up) - Cross TA - Miami

    Icon Clinical Research

    Clinical research coordinator job in Miami, FL

    Clinical Research Associate (Start Up) - Cross TA - Miami, FL ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What will you be doing?** + Works on multiple trials within the Cross Therapeutic areas - Start up focus + Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. + Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. + Build strong relationships with site personnel to facilitate a smooth onboarding process. + Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). + Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. + Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. + Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. + Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. + Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. + Proactively identify and address any issues that may delay study initiation or affect trial deliverables. + Maintain precise documentation to ensure readiness for inspections. + Support sites during the activation phase until they achieve "Green Light" status for site opening. + Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. + Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. **What do you need to have?** + Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences + Must be located in Miami, FL ; near a major airport. + Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $48k-76k yearly est. 5d ago
  • Clinical Research Associate

    Description This

    Clinical research coordinator job in Tampa, FL

    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.
    $48k-75k yearly est. Auto-Apply 13d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research coordinator job in Kinsey, AL

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K
    $51k-81k yearly est. 60d+ ago
  • Study Coordinator, Manager

    RPM Research 4.5company rating

    Clinical research coordinator job in Birmingham, AL

    Job Description Manager, Study Coordination & Quality Control Join a team driven by science, powered by people, and committed to improving lives. A GLP public CRO is seeking an experienced and passionate Manager, Study Coordination & Quality Control, to lead its Preclinical Operations team. In this critical leadership role, you will oversee project execution, ensure quality excellence, and mentor a talented group of Study Coordinators and Quality Control Specialists. If you thrive in a collaborative, fast-paced environment and have a strong commitment to scientific rigor and operational precision, we'd love to meet you. About the Role As the Manager of Study Coordination & QC, you will guide day-to-day operations, champion quality excellence, and empower your team to deliver project outcomes that are on time, within budget, and compliant with all standards. Working closely with Study Directors, Project Managers, and other internal partners, you'll ensure seamless planning, execution, and reporting across preclinical studies. You will play an instrumental role in optimizing workflows, monitoring financial impact, enhancing cross-functional processes, and elevating the quality of deliverables. This is an opportunity to create meaningful impact-from shaping departmental procedures to supporting studies that advance scientific innovation. Key Responsibilities Team Leadership & Development Lead, mentor, and develop a high-performing team of Study Coordinators and QC staff. Provide daily work direction, coaching, performance feedback, and career development. Foster a diverse, collaborative, and trust-centered team environment. Operational Execution Oversee study coordination activities from project initiation through reporting. Collaborate with Project Managers, Study Directors, and internal stakeholders to support costing, scheduling, tracking, and reporting. Ensure all work is completed accurately, on time, and within budget. Maintain operational calendars and oversee Provantis data collection software usage and data extraction. Quality Oversight Monitor end-to-end process quality; develop and track quality metrics across operations. Review protocols, amendments, and reports for accuracy and compliance. Participate in pre-study and post-project evaluations, identifying opportunities for improvement. Strategic & Administrative Contributions Participate in departmental budgeting and workload projections. Identify staffing needs; support recruitment, hiring, and performance management. Develop and maintain SOPs to ensure alignment with current practices. Promote safety standards and uphold strong business ethics. Qualifications Bachelor's degree required. Minimum 5 years of study coordination and QC experience in a preclinical or related scientific environment. Ability to meet medical and safety requirements (including required vaccinations). Proven leadership skills, strong communication abilities, and a commitment to operational excellence. What We Value Our core values shape how we work and how we lead: Cultivating Human Connection We put people first and believe in the power of trust, inclusion, and courageous teamwork. Operating with Precise Execution We leverage data, remain agile, take ownership of results, and treat feedback as an opportunity to grow. Harnessing Relentless Curiosity We ask sharp questions, push scientific boundaries, and continuously innovate. Stewarding a Healthy Community We prioritize safety, sustainability, dignity, and equitable opportunities for employees, customers, and communities alike. Behavioral & Leadership Expectations Build and maintain a high-trust, high-performance team. Communicate clearly and with impact across diverse audiences. Coach and develop others, recognizing achievements and addressing challenges promptly. Plan effectively, stay organized, and consistently deliver operational excellence. Work Environment This role includes work in both office and laboratory settings and requires the use of PPE, completion of medical evaluations, and the ability to receive experimental vaccines as required. Ready to Make an Impact? If you are driven by purpose, inspired by scientific progress, and energized by leading teams toward excellence, we encourage you to apply.
    $38k-53k yearly est. 13d ago
  • Research Study Coordinator

    Clearview Cancer Institute 3.6company rating

    Clinical research coordinator job in Huntsville, AL

    Clearview Cancer Institute is north Alabama's leading cancer treatment facility. For over 30 years Clearview Cancer Institute has provided leading-edge treatment and compassionate care to those diagnosed with cancer or blood disorders. Clearview offers every service and amenity needed in an outpatient setting and our dedication to research and involvement in Phase I-IV clinical trials gives our patients the opportunity to receive potentially life-saving treatment options. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: Job Purpose A Research Study Coordinator is responsible for the day-to-day planning, execution, and monitoring of complex oncology clinical research protocols. This is done in a manner to assure trial integrity and patient safety. Essential Job Functions Consents and acknowledges personal data are provided to study sponsors, CROs, auditors, and authorities in accordance with reporting guidelines for clinical trials, ICH, and the Code of Federal Regulations. Coordinates with research team, other CCI departments, trial sponsors, and patients to ensure protocol adherence Manages data collection, source documentation, case report forms, and adverse event reporting Performs patient recruitment, screening, enrollment, and follow-up in accordance with the trial's protocol Maintains GCP (Good Clinical Practice) and IATA certifications as required to uphold FDA standards regarding clinical trials Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and dispensation to research participants. Coordinate and attend trial initiation visits and attend all protocol required meetings and trainings. Coordinate patient care, safety, trial data collection, and quality with treating providers, PI, research staff, necessary CCI departments, and external providers Perform consent process defined by ICH GCPs and CCI Research SOPs. Directly interact with patients for clinical trial schedules, treatments, follow-up and study information. Pre-screening of patients using available electronic platforms for possible inclusion in clinical trials. Report SAEs according to protocol and SOPs. Maintain patient privacy and confidentiality in accordance with applicable law. Maintain study confidentiality. Must have strong computer skills and working knowledge of MS Office Suite, cloud-based EMR systems, data capture systems, medical terminology, and oncology terminology. Must be willing to learn and adapt to changing practices, systems, and requirements for efficient clinical management and clinical trial execution Provide payment milestones per CTA in a timely manner. Comply with CCI and departmental policies and procedures. Duties as assigned for trials according to trial delegation logs (DOAs) for clinical trials at CCI. Qualifications Must have demonstrated proficiency with Microsoft 365. Must have working knowledge of computer data management systems. Must have interest in clinical research. Must be detail-oriented with strong critical-thinking skills. Must have excellent communication skills, both oral and written Must work well independently and with diverse teams. Must have the ability to handle multiple priorities in a fast-paced environment Must have the ability to understand complex clinical trial protocols Education/Experience Must be registered nurse RN in good standing with the State of Alabama. Must have at least (1) year infusion experience. Must have at least (1) year oncology experience, preferred 2 years of oncology experience. Must have at least (1) year EMR experience. BSN RN preferred. GCP certification preferred. OCN certification preferred. At least (1) year research experience is preferred. Working conditions This position works in the research department of a busy outpatient medical facility. Direct patient care is required. Physical requirements Must be able to safely move patients. Must be able to lift and carry 30 pounds. Must be comfortable standing and walking for long periods of time. Must be willing to travel domestically up to 25% of the time. Must have reliable transportation. Direct reports This position is not a supervisory position.
    $41k-58k yearly est. Auto-Apply 60d+ ago
  • Assistant Clinical Research Coordinator

    Actalent

    Clinical research coordinator job in Orlando, FL

    We are seeking a dedicated person to join our team and support clinical study activities. This full-time role involves assisting the Clinical Research Coordinator and Investigator with various study tasks. You will play a crucial role in ensuring the quality and accuracy of clinical trial documentation. Responsibilities Assist the Clinical Research Coordinator and Investigator in conducting clinical study activities. Perform comprehensive Quality Control activities relating to the completion of source documents and Case Report Forms (CRFs) for clinical trials. Ensure adherence to clinical research Good Clinical Practice (GCP) requirements and medical documentation standards. Conduct intravenous (IV) procedures and phlebotomy, including blood draws. Participate in onsite Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) training before transitioning to a permanent role. Essential Skills Licensed Paramedic or EMT certification. Intermediate to advanced knowledge of Internet technology. Strong interpersonal and communication skills. Detail-oriented with strong document review abilities. Experience or training in clinical research GCP requirements and medical documentation. Additional Skills & Qualifications IV experience is preferred. Willingness to obtain BLS and ACLS certifications, with classes available onsite. Experience in customer service is an advantage. Work Environment The role is based in a 24-hour clinical research facility with a clinic-type setting. Schedule is Monday - Friday, 3:00PM -11:00PM Job Type & Location This is a Contract to Hire position based out of Orlando, FL. Pay and Benefits The pay range for this position is $20.00 - $21.00/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 Orlando,FL. Application Deadline This position is anticipated to close on Feb 4, 2026. 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.
    $20-21 hourly 5d ago
  • Clinical Research Coordinator - 249400

    Medix™ 4.5company rating

    Clinical research coordinator job in Cullman, AL

    Fully onsite - Direct Hire - ideally 2 years of CRC experience needed prior. Job Title: Clinical Research Coordinator (CRC) The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies. This role ensures studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), institutional policies, and regulatory guidelines. The CRC works closely with investigators, study sponsors, research participants, and regulatory bodies to ensure the successful execution of clinical trials. Key Responsibilities Coordinate and manage clinical research studies from start-up through close-out Screen, recruit, and enroll study participants according to protocol criteria Obtain and document informed consent in accordance with regulatory requirements Schedule and conduct study visits, procedures, and follow-ups Collect, document, and maintain accurate study data in source documents and electronic data capture (EDC) systems Ensure compliance with study protocols, GCP, IRB requirements, and applicable regulations Prepare and maintain regulatory documents, including IRB submissions, amendments, and continuing reviews Serve as the primary point of contact for sponsors, monitors, and study participants Assist with monitoring visits, audits, and inspections Track and report adverse events and protocol deviations Maintain study supplies, investigational product accountability, and inventory Collaborate with investigators and research team members to ensure study timelines and goals are met Public - Required Skills 2 Years of CRC Experience Comfortable working in a small team setting in a fast paced environment Public - Preferred Skills Spirometry training Public - Schedule/Shift Monday-Friday 8am-5pm
    $42k-59k yearly est. 2d ago
  • Clinical Research Coordinator III

    Denali Health 3.8company rating

    Clinical research coordinator job in Stone Mountain, GA

    Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities. Position Summary The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators. Key Responsibilities Coordination of Clinical Trials: Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies. Study Management: Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders. Participant Coordination: Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants. Regulatory and Compliance Oversight: Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times. Data Management: Enter, review, and verify data in EDC systems and ensure timely query resolution. Team Coordination & Leadership: Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability. Communication & Reporting: Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes. Qualifications Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred). Minimum 3-5 years of experience in clinical research coordination. Strong understanding of GCP, ICH, and FDA regulations. Exceptional coordination, multitasking, and communication skills. Experience with EDC systems and clinical trial management software preferred. CCRC/CCRP certification a plus. Why Join Denali Health Work with a mission-driven team advancing clinical research accessibility. Competitive salary and comprehensive benefits package. Professional growth and leadership opportunities. Collaborative environment focused on innovation and patient care. To Apply: Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ******************** with the subject line “Clinical Research Coordinator III - Stone Mountain.”
    $45k-67k yearly est. 22h ago
  • Physician Practice Clinic Coordinator

    Adventhealth 4.7company rating

    Clinical research coordinator job in Tampa, FL

    **Our promise to you:** Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better. **All the benefits and perks you need for you and your family:** + Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance + Paid Time Off from Day One + 403-B Retirement Plan + 4 Weeks 100% Paid Parental Leave + Career Development + Whole Person Well-being Resources + Mental Health Resources and Support + Pet Benefits **Schedule:** Full time **Shift:** Day (United States of America) **Address:** 3000 MEDICAL PARK DR **City:** TAMPA **State:** Florida **Postal Code:** 33613 **Job Description:** Shift: M-F FT 8-5 FT Performs other duties as assigned. Reviews charts proactively to identify gaps in care, insurance, orders, coding, and referrals. Completes weekly rounding activities and performs audits. Assists with patient experience improvements, clinical staff scheduling, education, and development conversations. Builds and maintains positive, effective relationships with all Physicians and APPs in their location. Assesses team members' clinical competency to complete tasks including but not limited to administering injections, drawing blood, rooming patients, and the like. Ensures workflow optimization and effectiveness for the team which includes Physicians, APPs, and staff. Assists daily with effective huddles (including Daily Management Boards) within the practice. Responsible for favorable results related throughput, patient experience, provider and staff satisfaction, and value based care. Completes operational processes that are focused on maximizing use of clinical space, ease of access to care, and patient flow. Manages patient care by reviewing Inbasket, schedules, radiology, and lab results, answering phones, and communicating with patients. Prepares next-day patient charts, ensuring all necessary information is available and communicated to doctors and front office staff. Assists physicians and advanced practice providers with medical equipment and procedures as needed. Maintains timely communication with patients regarding surgery, prescriptions, and testing. Ensures efficient patient work-up flow and triage responsibilities. Documents patient medications, messages, sample medications, and pharmacy information accurately and legibly. Stays current with new technology and updates on care and medications. Assists with prior authorizations, referrals, and procedural scheduling. Controls supplies and maintains inventory weekly. Precepts new clinical staff through skill validation. Demonstrates knowledge and compliance of Hospital guidelines and/or regulatory requirements. Contributes to the growth of the practice by managing patient flow and recommending follow-up visits if needed. Assists with Development Conversations for clinical staff. Attends POC meetings. Attend departmental meetings and stay up to date on all business initiatives related to the Practice. Completes Team Huddles to present current data and assist in action planning. **The expertise and experiences you'll need to succeed:** **QUALIFICATION REQUIREMENTS:** High School Grad or Equiv (Required), Technical/Vocational School (Required) Basic Life Support - CPR Cert (BLS) - RQI Resuscitation Quality Improvement, Certified Medical Assistant (CMA) - EV Accredited Issuing Body, Licensed Practical Nurse (LPN) - EV Accredited Issuing Body **Pay Range:** $20.38 - $32.60 _This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances._ **Category:** Medical Assistant & Technician Services **Organization:** AdventHealth Medical Group Support **Schedule:** Full time **Shift:** Day **Req ID:** 150659100
    $20.4-32.6 hourly 2d ago
  • Research Nurse (TRI)

    Actalent

    Clinical research coordinator job in Orlando, FL

    The Clinical Research Coordinator II RN (CRC-II RN) plays a crucial role in the research efforts of the institute. This position involves planning, coordinating, evaluating, and performing nursing care for research participants, as well as collecting data for assigned research projects. The role requires adherence to study-specific protocol guidelines and involves communication with Principal Investigators, Sub-Investigators, Clinical Research Leads, and other support staff. The CRC-II RN is dedicated to patient advocacy while conducting industry-sponsored and investigator-initiated clinical trials in compliance with trial protocols, FDA regulations, and ICH/GCP guidelines. Responsibilities Deliver safe nursing care with respect and dignity for all participants. Maintain clinical competencies such as physical assessment, phlebotomy, and IV insertion. Practice Universal Precautions and understand HIPAA regulations. Ensure clinical spaces are clean and prepared, performing set-up and turnover procedures as needed. Participate in training programs to maintain licensure. Communicate effectively with healthcare team members, patients, investigators, and sponsors. Review and adhere to IRB approved informed consent documents, advocating for patient rights and safety. Manage multiple clinical trial protocols, ensuring accurate and timely documentation. Securely manage records, study medications, and test articles. Promote PI oversight and report deviations or issues relevant to trial integrity and subject safety. Coordinate the work of support staff, laboratory technicians, and assistants to ensure adherence to protocols. Essential Skills Proficiency in clinical trial processes and data collection. Experience in oncology, dose calculations, consenting, and dosing. Knowledge of diabetes, clinical research, and GCP. Ability to perform EKG and other clinical tasks within the scope of practice. Minimum of 2 years of clinical research experience. Current, active State of Florida license as a Registered Nurse. BLS certification. Additional Skills & Qualifications Associate degree in Nursing. Skills in clinical competencies such as physical assessment, phlebotomy, and IV insertion. Ability to assist physicians and CRNs with procedures and study requirements. Adaptability to integrate into various clinical settings as needed. Work Environment The position is situated in a hospital setting, requiring adherence to hospital and departmental policies, SOPs, and all applicable regulations. Job Type & Location This is a Permanent position based out of Orlando, FL. Pay and Benefits The pay range for this position is $83200.00 - $98000.00/yr. Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance Paid Time Off from Day One 403-B Retirement Plan 4 Weeks 100% Paid Parental Leave Career Development Whole Person Well-being Resources Mental Health Resources and Support Pet Benefits Workplace Type This is a fully onsite position in Orlando,FL. Application Deadline This position is anticipated to close on Jan 26, 2026. 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.
    $83.2k-98k yearly 4d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Dothan, AL?

The average clinical research coordinator in Dothan, AL earns between $32,000 and $67,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Dothan, AL

$47,000
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