Senior Clinical Research Coordinator - Plant City, Florida
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.
Clinical Research Site Director - 248142
Clinical research coordinator job in Maitland, FL
We are hiring for a Clinical Research Site Director in the Orlando area. MUST have experience as a director at a site-level. Open to relocation candidates with the right experience.
Clinical Site Director (Onsite Role)
The Clinical Site Director is responsible for leading day-to-day operations at a clinical research center. This onsite position provides hands-on oversight to ensure that all clinical research activities are executed in alignment with ICH guidelines, GCP, FDA regulations, and internal policies. The role requires strong leadership, consistent presence at the site, and active management of research staff.
Key Responsibilities
Operational Leadership & Site Performance
Provide comprehensive onsite leadership to drive site performance, operational efficiency, participant safety, and adherence to regulatory and protocol requirements.
Oversee the daily functioning of the research site, ensuring staff coverage, quality standards, and smooth execution of study activities.
Cross-Functional Collaboration
Partner with internal teams across Business Development, Patient Recruitment, Finance, Budgets & Contracts, and Quality to align on expectations, maintain study timelines, meet enrollment goals, and deliver high-quality data to sponsors.
Study Oversight & Data Quality
Review performance dashboards and clinical trial systems to monitor patient flow, visit schedules, staff activity, and data updates.
Ensure timely and accurate completion of all required study activities, documentation, and communications.
Resource & Staff Management
Lead allocation of site resources, monitor study team performance, and identify operational or quality risks.
Manage, mentor, and evaluate research staff including coordinators and support personnel.
Oversee interviewing, hiring, performance evaluations, coaching, training, disciplinary actions, and (as needed) terminations.
Manage schedule approvals, payroll oversight, new hire onboarding, and ongoing staff development.
Training & Compliance
Facilitate initial and ongoing training on protocol requirements, CRF completion, SOPs, and operational guidelines.
Ensure strict adherence to SOPs, GCP, FDA regulations, and internal quality standards.
Identify compliance issues or process gaps and support the development and execution of corrective action plans.
Investigator & Sponsor Support
Collaborate closely with investigators to uphold participant safety and meet protocol expectations.
Provide proactive risk mitigation strategies and support sponsor expectations throughout the study lifecycle.
Administrative & Leadership Duties
Participate in leadership, site, and sponsor meetings as needed.
Perform additional duties as assigned to support the success of the research site.
Skills, Knowledge & Expertise
Minimum Qualifications
Bachelor's degree and 5+ years of clinical research experience; an equivalent combination of education and experience may be considered.
At least 2 years of supervisory or management experience, ideally within a clinical research site setting.
Bilingual (English/Spanish) proficiency is preferred.
Required Skills
Strong organizational, time-management, problem-solving, and project management skills.
Excellent written and verbal communication abilities.
Strong interpersonal skills with the ability to work effectively with colleagues, participants, investigators, and external partners.
Ability to manage multiple priorities and adapt to shifting demands.
Professional demeanor with a high level of integrity, dependability, and initiative.
Ability to work independently, identify operational issues, and implement solutions.
Strict adherence to confidentiality standards, including HIPAA requirements.
Senior Clinical Research Coordinator
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)
Research Associate 3, Oncology Clinical Trials, FT, 8:00A - 4:30P
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
EVS Senior Coordinator- Orlando Health Watson Clinic Lakeland Highlands Hospital-Lakeland, FL
Clinical research coordinator job in Lakeland, FL
The Environmental Services (EVS) Coordinator is responsible for assisting the supervisor with day-to-day operations, which includescheduling and training of staff, monitoring quality and operating all equipment as necessary. Position requires individual to train teammembers, monitor all essential functions for all current employees and, serve as a working lead covering positions in EnvironmentalServices. The position is responsible for executing the daily duties required to establish and maintain a safe, clean, healing environment development and monitoring EVS and procedures and contributes to department quality initiatives and programs serves as a member of the EVS Leadership team and assumes shift/operational responsibility in the absence of the supervisor. Opening Summer 2026 at 4000 Lakeland Highlands Road, Lakeland, FL. The Orlando Health System of Care includes award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities that span Florida's east to west coasts, Central Alabama and Puerto Rico. Collectively, our dedicated team members honor our over 100-year legacy by providing professional and compassionate care to the patients, families and communities we serve. Join us! Combining the collective strengths of two powerhouse organizations, Orlando Health and the high-quality physicians at Watson Clinic are expanding access to award-winning specialty care for patients in Polk County and beyond. Opening in summer 2026, Orlando Health Watson Clinic Lakeland Highlands Hospital - a state-of-the-art, seven-story, multi-specialty hospital - will serve as a vital 550,000 square-foot healthcare hub offering: 300+ inpatient beds and 69 emergency and observation beds 11 operating rooms and four cardiac interventional suites Dedicated labor and delivery services - including a neonatal intensive care unit (NICU) that will debut shortly after the hospital opens Comprehensive cardiovascular, neurology, and oncology services Advanced surgical procedures Join us in shaping the future of healthcare in Polk County as part of the Orlando Health Watson Clinic Lakeland Highlands Hospital opening team and share in the privilege of saying you were there from the very beginning. Benefits Beyond the Expected Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible, so that you can be present for your passions. "Orlando Health Is Your Best Place to Work" is not just something we say, it's our promise to you. Benefits that begin on Day 1 Four (4) weeks paid parental leave Debt-free degrees through our Preferred Education Program Tuition reimbursement and loan repayment programs Back-up childcare and elder care Fertility benefits and adoption assistance NCLEX reimbursement Free NCPDs for RN license Free Kaplan review courses Dedicated RN career counselor and GN Coordinators to develop you Specialty certifications reimbursement And more! Responsibilities Essential Functions • Conducts one-on-one training sessions using approved techniques, procedures, and educational materials in the training process. • Provides instruction to new hires and current employees in various areas. • Properly demonstrating technical skills, including steps cleaning process for patient & non-patient rooms, isolation rooms, critical care areas, ER trauma units, and ancillary areas including, but not limited to restrooms/bathrooms, public areas, corridors, and any other areas that may require attention. • Ability to respond to common inquiries or complaints from customers, using appropriate designated engagement techniques. • Maintains accurate floor care logs and checklists. • Able to mix chemicals according to instructions. • Recognizes the importance of how their communication is received by patients, visitors and other health care workers, staff, etc. • Recognizes their role as part of the larger organization and models the mission statement through interaction with patients, family, visitors, and other facility staff. Adheres to all Standards of Precaution, SDS and Hand Hygiene directives. • Must complete all mandatory training as designated and required. • Participates in departmental quality assurance and improvement activities as appropriate. • Must be able to maintain productivity and volume standards established for the assigned facility. • Keeps current with all policies and procedures of the hospital and the department. • Practices critical thinking skills to include prioritization of duties and immediate needs/requests (Stat cleans) • Identify and utilize appropriate resources to ensure identified problems or concerns are followed through • Demonstrate knowledge of facility safety requirements. • Demonstrates the ability to operate and properly maintain all EVS tools and equipment needed to clean and disinfect the environment. • Assists in onboarding new Environmental Services Technicians I, II, III and IV and V's as requested. • Cleaning duties include, but are not limited to patient bed, furniture, light fixtures, ceiling vents, windows, window • Instructs proper procedures for replenishing supplies as needed. • in the use of programs that include the hospitals bed management system. • Instructs in accomplishes these functions by pushing, pulling, cleaning carts, moving supplies and equipment, carrying buckets, operating equipment such as vacuum cleaners and wearing protective clothing as required by work environment or regulatory agency. • Provides comprehensive oversight of the shift • Provides new hires 60 Day evaluations and assist with annual competencies. • Interfaces with Supervisors, Office Coordinators, Ops. Managers and Director. • Proactively handles any improvement opportunities or concerns. Leads or participates in performance improvement projects and process improvement efforts. • Research, coordinates, and implements core training programs and systems (cleaning and disinfection practices, protocols, auditing tools, competencies, job aides, in-services, skills labs, etc.). • Develops and utilizes appropriate evaluation systems to measure effectiveness of educational activities and uses feedback to adjust programs accordingly. • Collaboratively selects training materials with department director and/or manager. • Maintains and organizes training materials and associated validation of employee competency training to meet accreditation requirements. • Establishes EVS annual continuing education calendar. • Completes training evaluations and critique reports for each individual trainee. Qualifications Education/Training • High School Diploma or GED Licensure/Certification • DOT (Department of Transportation) Certification • (CSCT) Certified Surgical Cleaning Technician • (CHEST Certification) Certified Healthcare Environmental Services Professional Experience Experience • Five (5) years health care environmental services experience • Analytical and oral communication skills. • Bed Management Systems
Education/Training • High School Diploma or GED Licensure/Certification • DOT (Department of Transportation) Certification • (CSCT) Certified Surgical Cleaning Technician • (CHEST Certification) Certified Healthcare Environmental Services Professional Experience Experience • Five (5) years health care environmental services experience • Analytical and oral communication skills. • Bed Management Systems
Essential Functions • Conducts one-on-one training sessions using approved techniques, procedures, and educational materials in the training process. • Provides instruction to new hires and current employees in various areas. • Properly demonstrating technical skills, including steps cleaning process for patient & non-patient rooms, isolation rooms, critical care areas, ER trauma units, and ancillary areas including, but not limited to restrooms/bathrooms, public areas, corridors, and any other areas that may require attention. • Ability to respond to common inquiries or complaints from customers, using appropriate designated engagement techniques. • Maintains accurate floor care logs and checklists. • Able to mix chemicals according to instructions. • Recognizes the importance of how their communication is received by patients, visitors and other health care workers, staff, etc. • Recognizes their role as part of the larger organization and models the mission statement through interaction with patients, family, visitors, and other facility staff. Adheres to all Standards of Precaution, SDS and Hand Hygiene directives. • Must complete all mandatory training as designated and required. • Participates in departmental quality assurance and improvement activities as appropriate. • Must be able to maintain productivity and volume standards established for the assigned facility. • Keeps current with all policies and procedures of the hospital and the department. • Practices critical thinking skills to include prioritization of duties and immediate needs/requests (Stat cleans) • Identify and utilize appropriate resources to ensure identified problems or concerns are followed through • Demonstrate knowledge of facility safety requirements. • Demonstrates the ability to operate and properly maintain all EVS tools and equipment needed to clean and disinfect the environment. • Assists in onboarding new Environmental Services Technicians I, II, III and IV and V's as requested. • Cleaning duties include, but are not limited to patient bed, furniture, light fixtures, ceiling vents, windows, window • Instructs proper procedures for replenishing supplies as needed. • in the use of programs that include the hospitals bed management system. • Instructs in accomplishes these functions by pushing, pulling, cleaning carts, moving supplies and equipment, carrying buckets, operating equipment such as vacuum cleaners and wearing protective clothing as required by work environment or regulatory agency. • Provides comprehensive oversight of the shift • Provides new hires 60 Day evaluations and assist with annual competencies. • Interfaces with Supervisors, Office Coordinators, Ops. Managers and Director. • Proactively handles any improvement opportunities or concerns. Leads or participates in performance improvement projects and process improvement efforts. • Research, coordinates, and implements core training programs and systems (cleaning and disinfection practices, protocols, auditing tools, competencies, job aides, in-services, skills labs, etc.). • Develops and utilizes appropriate evaluation systems to measure effectiveness of educational activities and uses feedback to adjust programs accordingly. • Collaboratively selects training materials with department director and/or manager. • Maintains and organizes training materials and associated validation of employee competency training to meet accreditation requirements. • Establishes EVS annual continuing education calendar. • Completes training evaluations and critique reports for each individual trainee.
Auto-ApplyResearch Coordinator (College of Medicine)
Clinical research coordinator job in Tallahassee, FL
Department Translational Behavioral Research | Center for Translational Behavioral Science Responsibilities This position will provide research support at the Center for Translational Behavioral Science (CTBS), GROWTH Research Lab, and Scale it Up Florida Program.
Support the development of standard operating procedures, assist study investigators with the design and implementation of data capture systems and data management, oversee research participant recruitment, consent, enrollment and retention in active research projects with a focus on emerging adult health (e.g., substance use prevention and treatment, HIV prevention and treatment, mental health) assist investigators with internal and external project reporting requirements, and participate in community engagement and dissemination efforts.
Tracking project timelines, tasks, and study benchmarks as well as attending and participating in project meetings. As part of participating in research studies, this position may also support quantitative and qualitative data collection, management, and analysis.
Support regulatory activities associated with funded projects including initiation and monitoring of study regulatory agreements and research study protocol development and modifications. As part of the CTBS Research Development Core, this position will support the Center Assistant Director in development core operations and serve as liaison with center faculty to provide consultative support for grant submissions and regulatory components of research, as assigned.
Support the implementation of evidence-based practice initiatives and support community-focused, motivational interview training.
Supervision of Research Assistants helping with research recruitment, developing literature reviews, and other research tasks.
Qualifications
Bachelor's degree and two years of experience; or a high school diploma/equivalent and six years of experience. (Note: a combination of post high school education and experience equal to six years.)
This position requires successful completion of the eSPEAR Certification or ability to obtain the certification within 6 months of hire.
University Information
One of the nation's elite research universities, Florida State University preserves, expands, and disseminates knowledge in the sciences, technology, arts, humanities, and professions, while embracing a philosophy of learning strongly rooted in the traditions of the liberal arts and critical thinking. Founded in 1851, Florida State University is the oldest continuous site of higher education in Florida. FSU is a community steeped in tradition that fosters research and encourages creativity. At FSU, there's the excitement of being part of a vibrant academic and professional community, surrounded by people whose ideas are shaping tomorrow's news!
Learn more about our university and campuses.
FSU Total Rewards
FSU offers a robust Total Rewards package. Visit our website to learn more about our Compensation, Benefits, Wellness, Recognition, and Employee Development programs.
Use our interactive tool to calculate Total Compensation options based on potential salary, benefits and retirement contributions, earned leave, and other employment-related perks.
How To Apply
If qualified and interested in a specific job opening as advertised, apply to Florida State University at ********************* If you are a current FSU employee, apply via my FSU > Self Service.
Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.
Considerations
This is an A&P position.
This position requires successful completion of a criminal history background check.
This position is being advertised as open until filled.
Equal Employment Opportunity
FSU is an Equal Employment Opportunity Employer.
Sr. Clinical Study Manager - Device
Clinical research coordinator job in Orlando, FL
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit ****************************
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit ****************************
About the role
This is a remote US-Based role, seeking someone residing in the Eastern Time Zone
Key Responsibilities:
* Proactively manage assigned clinical studies.
* Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm and innovation.
* Identify and escalate clinical study risks and propose solutions for risk mitigation.
* Oversee clinical study finance tracking, identify and escalate potential risks.
* Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.
* Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR).
* Motivate a multi-disciplinary clinical study team.
* Drive milestone achievement through management of study issues and conflict resolution with limited oversight.
* Oversee 3rd party Vendors where necessary to support milestone achievement.
* Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.
* Support audit and inspection activities as needed.
* Update processes and SOPs, providing input in discussions around quality by design and operational delivery.
* Demonstrate Convatec's core values.
* May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
Authority (if applicable):
Ability to provide recommendations and suggestions to ensure delivery of assigned clinical study(s).
Skills & Experience:
* Strong knowledge of the clinical study lifecycle.
* Clinical study management skills, including the ability to manage timelines, budgets and resources effectively.
* Medical Device experience essential.
* Keen attention to detail.
* Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
* Excellent collaborative team player.
* Experience in pre-market (IDE) and post-market clinical studies.
* Experience with Clinical Trial Management Systems.
Qualifications/Education:
* Bachelor's or Master's degree required, preferably in life sciences, medicine, or related discipline.
* Minimum of 10 years Clinical Research experience, preferably some within the medical device arena, with at least 5 years of experience in clinical study management. Years of experience may be considered in lieu of education.
Dimensions:
Principal Contacts & Purpose of Contact
Internal - Medical Affairs, Clinical Operations (Study Management, Site Management, Study Co-ordination, Data Analytics), Evidence Genertion, R&D
External - Vendors, Clinical Sites, Regulatory approvers (FDA, Competent Authorities, IRB/EC)
Travel Requirements
Position may involve travel up to 20% of the time, mostly domestic but some international travel may be required. Trips may include overnight travel.
Languages
* Speaking: Yes English
* Writing/Reading: Yes English
Working Conditions
Remote Working, however, occasional travel into the home office may be required.
Special Factors
Good working knowledge of Microsoft Suite including Office (Word,Excel,Powerpoint), Project, Teams
Flexibility to work across multiple time zones will be required.
Training will be provided at the Corporate, Department and Job Function level.
Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
#LI-LM1
#LI-Remote
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at ********************.
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!
Easy ApplyTravel Clinical Research Coordinator
Clinical research coordinator job in Orlando, FL
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members.
The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
How You'll Make An Impact
* Study Preparation:
* Ability to understand and follow institutional SOPs
* Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
* Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
* Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
* Assist with planning and creation of appropriate recruitment and marketing materials
* Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.
* Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
* Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
* Assist in the creation or review of protocol specific source documents
* Determine facility, equipment and outsource vendor requirements and availability
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance
* Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
* Study Management:
* Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.
* Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
* Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
* Collect and evaluate concomitant medications
* Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
* Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
* Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
* Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion
* Maintain effective relationships with study participants and other Care Access Research personnel
* Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
* Strong and clear communication skills, both verbally and in writing
* Accept accountability for actions and function independently
* Patient Coordination:
* Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
* Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial
* Administer delegated study questionnaires, where appropriate.
* Collect and evaluate medical records with the support of medically qualified members of the study team.
* Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
* Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
* Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
* Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
* Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
* Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
* Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
* Monitor patient progress on study medication
* Documentation:
* Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
* Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
* Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
* Accurately transcribe data to CRF or EDC.
* Resolve data management queries and correct source data as needed
* Record protocol exemptions and deviations as appropriate with sponsor.
* Complete Note(s)-to-File for patient chart and regulatory filing if necessary
* Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
* Maintain copies of patient-specific correspondence in source charts
* Assist regulatory personnel with completion of continuing/final review reports
* Perform other duties as assigned.
The Expertise Required
* Excellent working knowledge of clinical trials, medicine and research terminology
* Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
* Ability to communicate and work effectively with a diverse team of professionals
* Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
* Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
* Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
* Critical thinker and problem solver
* Friendly, outgoing personality; maintain a positive attitude under pressure
* High level of self-motivation and energy
* Excellent professional writing and communication skills
* Ability to work independently in a fast-paced environment with minimal supervision
Certifications/Licenses, Education, and Experience:
* BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
* RN or LPN preferred
* Research Professional Certification- CRCC or exam eligibility preferred
* A minimum of 3 to 4 years Clinical Research experience
* A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
How We Work Together
* Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study.
The expected salary range for this role is $70,000-$100,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees Only)
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Event (C.N.A., RN, LPN) -1/15/2026 8:30am -11:30am & 1pm-4pm
Clinical research coordinator job in West Palm Beach, FL
Job Description
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
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Staff Clinical Trial Specialist
Clinical research coordinator job in Jacksonville, FL
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Jacksonville, Florida, United States of America
Job Description:
We are searching for the best talent to join our Vision team as a Staff Clinical Trial Specialist located in Jacksonville, FL
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
Purpose: The Staff Clinical Trials Specialist manages study conduct under the guidance of a senior level manager ensuring that operating procedures and company policies are followed. The Staff Clinical Trial Specialist develops and manages timelines, resourcing, and budget for assigned clinical trials. They build cross-functional support for innovative solutions and facilitate successful study team behavior. They partner with Research & Development and Research Scientists/Clinicians to ensure study results and timelines are met. They maintain relationships externally with strategic partners, monitors, Clinical Research Organizations, and study site investigators/personnel. They adhere to environmental policy, procedures, and support department environmental objectives. They engage in Credo-based decision-making where our responsibility is to our patients and doctors.
You will:
Own processes and information required to complete and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
Accountable for the preparation and finalization of key clinical documents which include the informed consent, case report forms, and other essential study documents
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required for testing investigational and/or marketed devices
Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
Contribute to the improvement of clinical trial processes, including benchmarking and maximizing across other J&J companies
Other related duties as assigned by management
Qualifications:
Bachelor of Science or equivalent degree
5+ years' experience in Clinical Research in a medical device or pharmaceutical regulated industry
Must have a minimum of 2 years' experience as a clinical research associate
Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
Strong communication, organizational and interpersonal skills
Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.)
Ability to effectively work with a team and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met
Travel: Up to 20%
#LI-AM2
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Clinical Studies, Clinical Trials, CRA Training
Auto-ApplyStaff Clinical Trial Specialist
Clinical research coordinator job in Jacksonville, FL
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Jacksonville, Florida, United States of America
Job Description:
We are searching for the best talent to join our Vision team as a Staff Clinical Trial Specialist located in Jacksonville, FL
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
Purpose: The Staff Clinical Trials Specialist manages study conduct under the guidance of a senior level manager ensuring that operating procedures and company policies are followed. The Staff Clinical Trial Specialist develops and manages timelines, resourcing, and budget for assigned clinical trials. They build cross-functional support for innovative solutions and facilitate successful study team behavior. They partner with Research & Development and Research Scientists/Clinicians to ensure study results and timelines are met. They maintain relationships externally with strategic partners, monitors, Clinical Research Organizations, and study site investigators/personnel. They adhere to environmental policy, procedures, and support department environmental objectives. They engage in Credo-based decision-making where our responsibility is to our patients and doctors.
You will:
Own processes and information required to complete and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
Accountable for the preparation and finalization of key clinical documents which include the informed consent, case report forms, and other essential study documents
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required for testing investigational and/or marketed devices
Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
Contribute to the improvement of clinical trial processes, including benchmarking and maximizing across other J&J companies
Other related duties as assigned by management
Qualifications:
Bachelor of Science or equivalent degree
5+ years' experience in Clinical Research in a medical device or pharmaceutical regulated industry
Must have a minimum of 2 years' experience as a clinical research associate
Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
Strong communication, organizational and interpersonal skills
Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.)
Ability to effectively work with a team and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met
Travel: Up to 20%
#LI-AM2
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Clinical Studies, Clinical Trials, CRA Training
Auto-ApplyClinical Research Coordinator II
Clinical research coordinator job in Tampa, FL
The primary purpose of this position is to be the main point of contact for sponsors and patients for specific research protocols. This position is responsible for performing the screening, enrollment, and retention of study participants, ensuring quality of data collected throughout the research study, and implementing the procedures and activities under the direction and oversight of the lead coordinators and principal investigators of the projects.
Minimum Education & Experience
• Bachelor's degree in a related field -OR- equivalent combination of education and experience.
• Minimum of two (2) years of related experience.
• Senate Bill 1310- The Florida Senate (************************************************ is
conditional upon meeting all employment eligibility requirements in the U.S.
• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
• A public employer may include a postsecondary degree as a baseline requirement only as an
alternative to the number of years of direct experience required, not to exceed:
• (a) Two years of direct experience for an associate degree;
• (b) Four years of direct experience for a bachelor's degree;
• (c) Six years of direct experience for a master's degree;
• (d) Seven years of direct experience for a professional degree; or
• (e) Nine years of direct experience for a doctoral degree
• Related work experience may not substitute for any required licensure, certification, or registration
required for the position of employment as established by the public employer and indicated in the
advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.
Knowledge, Skills & Abilities
• Comprehension of clinical research principles, Good Clinical Practice Guidelines, and regulatory
requirements.
• Attention to detail, critical thinking, ability to follow protocols,
• Ability to maintain quality standards, planning and scheduling, data collection, clear
communication, and organization.
• Ability to communicate and interact competently and professionally at all levels within a broad,
complex clinical research environment.
• Ability to provide technical advice, guidance, and support to professional and support staff
• Skill in the use of personal computers and related software applications.
Working Conditions
• Environment - Typical indoor environment/office setting.
• Physical Requirements - climbing, standing, stooping, and/or typing; Ability to lift up to 20lbs as
needed.
• Travel - Ability to travel to other USF campuses and/or other locations as requested.
Primary Job Duties
• Plans, organizes, and manages the resources necessary to achieve clinical research project
goals and objectives at a single site.
• Coordinates and performs patient clinical assessments for clinical trial visits for assigned clinical trial protocols including scheduling with vendors which may include other departments or outside facilities. This may include phlebotomy, sample processing, vitals, ECGs and other delegated clinical assessments per assigned protocols.
• Communicates as a site representative with study sponsors, third party vendors, clinical teams and patients to ensure all protocol required elements are being completed and collected within the defined windows.
• Ensures site compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends site monitoring meetings with sponsors.
• Manages the site research project databases, develops flowsheets and other study related documents, and completes source documents/case report forms.
• May provide guidance to other clinical research staff and support personnel.
• Makes recommendations of procedures in order to facilitate protocol compliance.
• Performs data entry and query resolution during the duration of each trial assigned.
• Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes at the site.
• Performs other duties as assigned.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Orlando, FL
HealthCare Support Staffing, Inc. (HSS), is a proven industry-leading national healthcare recruiting and staffing firm. HSS has a proven history of placing talented healthcare professionals in clinical and non-clinical positions with some of the largest and most prestigious healthcare facilities including: Fortune 100 Health Plans, Mail Order Pharmacies, Medical Billing Centers, Hospitals, Laboratories, Surgery Centers, Private Practices, and many other healthcare facilities throughout the United States. HealthCare Support Staffing maintains strong relationships with top providers in healthcare and can assure healthcare professionals they will receive fast access to great career opportunities that best fit their expertise. Connect with one of our Professional Recruiting Consultants today to see how a conversation can turn into a long-lasting and rewarding career!
Job Description
Fast paced environment. Room study patients, take vitals, and follow research study guides and regulations.
Qualifications
LPN or RN
Someone with a 4 year degree that has previous research experience OR
Individual who has a two year degree and CCRC (Certified Clinical Research Coordinator) certification
Additional Information
Shift: Monday-Friday
Schedule will 7:30-4, possible weekend overtime pending how busy the clinic is
Pay Rate: $20-$25 per hr
Clinical Research Coordinator
Clinical research coordinator job in Jacksonville, FL
The Clinical Research Coordinator (CRC) coordinates, implements and completes clinical research studies and/or clinical trials in by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Participates in continuous process improvement initiatives and implementation of outcomes
Prepares for internal and external audits. Prepares corrective action plans as indicated.
Qualifications:
Bachelor's degree in medical or science related field required
A minimum of 1 year of research experience required
Has CRC certification or eligible to sit for exam after 2 years experience
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Jacksonville, FL
The Clinical Research Coordinator (CRC) coordinates, implements and completes clinical research studies and/or clinical trials in by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
* Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
* Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
* Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
* Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
* Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
* Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
* Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
* Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
* Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
* Participates in continuous process improvement initiatives and implementation of outcomes
* Prepares for internal and external audits. Prepares corrective action plans as indicated.
Qualifications:
* Bachelor's degree in medical or science related field required
* A minimum of 1 year of research experience required
* Has CRC certification or eligible to sit for exam after 2 years experience
* Effectively uses Microsoft computer software
* Demonstrates ability to coordinate and establish priorities among diverse tasks
* Effectively communicates verbally and in writing
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Jacksonville, FL
The Clinical Research Coordinator (CRC) coordinates, implements and completes clinical research studies and/or clinical trials in by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Participates in continuous process improvement initiatives and implementation of outcomes
Prepares for internal and external audits. Prepares corrective action plans as indicated.
Qualifications:
Bachelor's degree in medical or science related field required
A minimum of 1 year of research experience required
Has CRC certification or eligible to sit for exam after 2 years experience
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Auto-ApplyClinical Research Coordinator Fort Myers South FL
Clinical research coordinator job in Fort Myers, FL
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.
Clinical Research Coordinator
Clinical research coordinator job in Winter Park, FL
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 Winter Park, 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, 8 AM - 4:30 PM (occasional weekends)
Location: 1788 W Fairbanks Ave Suite A, Winter Park, FL 32789
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
Bilingual Spanish candidates will be highly considered!
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.
Auto-ApplyClinical Research Coordinator - Float
Clinical research coordinator job in Jacksonville, FL
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”
Auto-ApplyClinical Research Coordinator III - 991388
Clinical research coordinator job in Fort Lauderdale, FL
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.