Research Nurse - Oncology
Clinical Research Associate Job In Fort Myers, FL
Department: Clinical Research RCC
Work Type: Full Time
Shift: Shift 1/8:00:00 AM to 4:30:00 PM
Minimum to Midpoint Pay Rate:$33.37 - $45.05 / hour
Join us and be valued as a person, not just an employee, within a culture built onteamwork, empowerment, and continuous improvement. We have created something truly exceptional in Southwest Florida, with careers for compassionate health care professionals eager to realize their full potential across a diversity of opportunities throughout our health system. Lee Health believes ingrowth, education, and advancement.
Learn more about Lee Health by clicking the following link:
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To schedule a phone interview with the recruiter, click on the following link:**********************
Summary
The Clinical Research Nurse plans, coordinates, evaluates, and manages nursing care of participants and data for assigned research projects. Follows study specific protocol guidelines; communicates and interacts with Investigators, hospital staff, sponsoring agencies, and others to effectively perform clinical research; and coordinates research activities. Includes patient advocacy and education, education of other personnel, and marketing and promotion of the program. Abides by hospital and departmental policies and standard operating procedures, as well as all applicable local, state, and federal regulations. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
Requirements
Educational Requirements
Degree/Diploma ObtainedProgram of StudyRequired/
Preferredand/or Associate'sNursingRequiredBachelor'sNursingPreferred
Experience Requirements
Minimum Years RequiredArea of ExperienceRequired/
Preferredand/or
Additional Requirements
5 years as clinical research associate required with an Associates degree. Previous research experience with a Bachelors degree is not required.
State of Florida Licensure Requirements
LicensesRequired/
Preferredand/or Registered Nurse LicenseRequired
Certifications/Registration Requirements
Certificates/RegistrationsRequired/
Preferredand/or BLS (American Heart Association / Basic Life Support) RequiredandACLS (American Heart Association / Advanced Cardiac Life Support) Preferred
Additional Requirements
SOCRA preferred Other: The nurse researcher is experienced in nursing research. Intermediate computer skills: MS Windows, MS Word, MS PowerPoint and MS Excel
US:FL:Fort Myers
Senior Clinical Research Associate (onsite)
Clinical Research Associate Job In Miami, FL
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for monitoring the in-house blood draw program and coordinating the efforts to add new study sites to the program.
This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs Department located in Chaska, MN and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the CCIA Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a cross-functional, detail-oriented role and want to work to build a world-class Clinical organization-read on.
In this role, you will have the opportunity to:
Set up the in-house blood draw program across US and OUS Beckman Coulter locations, ensuring the program meets the needs of cross-functional teams and complies with GCP, IRB policies and procedures, and applicable Standard Operating Procedures (SOP).
Conduct onsite and remote monitoring visits (SIV, IMV, COV) to perform proactive document/data review to identify discrepancies and protocol deviations, overseeing corrective actions to drive compliance with study protocol(s). Effectively escalate and collaborate with site personnel and internal team members to propose solutions to sustain good compliance.
Support development of study essential document templates (e.g., study guides, study
tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation.
Support the in-house biorepository by receiving, shipping, and tracking clinical study samples.
May perform other clinical project activities such as drafting documents, reports, data summaries, presentations, conducting literature searches, publication and/or podium planning.
The essential requirements of the job include:
Bachelor of Science degree in the life sciences or related field required with 5+ years of clinical trial experience in vitro diagnostics (IVD), medical device, or healthcare clinical field.
Demonstrated agility with processes and details, ability to apply critical thinking and solve complex problems.
Effectively communicate with internal and external stakeholders who possess various levels of clinical research experience.
Ability to independently complete IRB submissions (initial review, change in research, continuing review, closeout report).
Thorough understanding of Good Clinical Practice (GCP).
It would be a plus if you also possess previous experience in:
Global Clinical Trials Monitoring/Management
Experience with electronic Trial Master Files
Project Coordination/Management
The salary range OR the hourly range for this role is $98,000 - $122,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
#LI-LM3
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit ****************
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
Clinical Research Project Manager
Clinical Research Associate Job In Pompano Beach, FL
The Clinical Research Project Manager position is an excellent opportunity for an individual who is interested in assisting a fast-emerging biopharmaceutical company conduct unique first-in-human, clinical research trials with multiple therapeutics. You will work under general supervision to manager a number of clinical research studies and manages data collection and submissions for multiple clinical trials. This position entails a high volume of document control and data abstraction; no patient contact.
Principal Duties And Responsibilities
The following duties will be performed under general supervision by the VP of Research and Manufacturing:
· Manage several ongoing and future clinical research project
· Write clinical research protocols
· Monitor and evaluate protocol compliance
· Manage data collection via chart abstraction and submit data
· Write informed consent documents
· Monitor and report adverse events as required by institutional/federal regulations
· Prepare submission of protocol revisions and safety reports to the IRB
· Prepare annual progress reports for IND and IRB renewal of ongoing studies
· Organize monitoring visits as requested by sponsors and make data corrections as required by monitor
· Resolve data discrepancies
· Assess impact of new risk information on consent documents and revise appropriately
· Exercise sound judgment in making critical decisions
Skills/Abilities/Competencies Required
· Careful attention to detail
· Good organizational skills
· Ability to follow directions
· Good communication skills
· Computer literacy
· Working knowledge of clinical research protocols
· Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Education
· Bachelor's degree required.
· Minimum 2 years of relevant experience
Primary Location
Remote
Job
Research-Management
Organization
ZEO ScientifiX
Seniority Level
Mid-level Associate
Industry
Biotechnology
Employment Type
Full-time
Clinical Coordinator Radiology School Full Time Days
Clinical Research Associate Job In Pembroke Pines, FL
Responsible for student supervision and monitoring clinical performance of the Radiology Student Training Program of students while at clinical sites in conjunction with Clinical Instructors.
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Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.
Clinical Coordinator Medical Surgical
Clinical Research Associate Job In Titusville, FL
Department: Medical Surgical Schedule/Status: Nights; Full Time Standard Hours/Week: 40; Full Time GENERAL DESCRIPTION Under the general supervision of the Director/Nurse Manager/Administrative Supervisor, the Clinical Coordinator is responsible for the day-to-day and monthly scheduling, assignment and supervision of nursing care as appropriate to the ages of the patients served. The Clinical Coordinator through team nursing and the multi-disciplinary team facilities assessment, planning, coordination, implementation, and evaluation of the plan of care. The Clinical Coordinator monitors care delivery to ensure quality, appropriateness, timeliness, and effectiveness of the care rendered. On the day shift, the Clinical Coordinator manages the unit activities in the absence of Director/Nurse Manager.
KEY RESPONSIBILITIES
Facilitates the RN as Coordinator of Care and activities of the multidisciplinary team and/or other agencies. The Clinical Coordinator may verify orders, maintains the confidential and professional environment of the unit, and acts as a resource to the unit staff.*
Evaluates care delivery, patient satisfaction and works with staff to resolve problems. Investigates and documents resolution of variance reports.*
Facilitates effective communication with co-workers, physicians, patients, families, and other health care team members. Promotes and models utilization of the SBAR format to co-workers for all handoff reports and changes in patient's status. Follows the chain of command.*
Completes monthly time schedules and adjusts daily to cover call-in and shortages. Adjusts daily staffing to cover call-ins and shortages. Prepares daily assignments.*
Retains competency as a team leader and participates in direct care delivery as needed.*
Evaluates performance of designated staff and writes performance appraisals. Identifies and documents situations that require further guidance and counseling of staff.*
Coordinates and participates in staff development, and assists the Nurse Manager/Director in directing the orientation of new staff. Checks staff competencies.*
In the absence of the Nurse Manager/Director, or when assigned, coordinates the activities on the unit. Performs payroll edits, as assigned.
Participates on committees, and supervises unit process improvement initiatives to improve the effectiveness of nursing practice.
Performs other duties as assigned.
Knows fire, disaster and safety procedures and regulations as it pertains to the work area
KEY JOB REQUIREMENTS
Formal Education:
Associates' degree in nursing, required
Bachelor's degree in nursing, preferred
Work Experience:
Minimum of three (3) years' experience.
Required Licenses, Certifications, Registrations:
State of Florida RN
BCLS, EKG competency, if applicable
ACLS or PALS or NRP certification preferred
Full Time Benefits:
Eligible to participate in a number of PMC-sponsored benefits, including:
Annual Accrual of 152 Personal Leave Bank (PLB) Hours
Health, Dental and Vision Insurance
403(b) Retirement Program
Tuition Reimbursement/Educational Assistance
EAP, Flex Spending, Accident, Critical and Other Applicable Benefits
#PRG
Parrish Healthcare is a caring community of healthcare professionals passionate about excellence and fulfilling our mission of providing Healing Experiences For Everyone All The Time.
Parrish Healthcare has a Culture of Choice. This means a we have a healing work environment that empowers people to aspire to be their very best. We partner passionate, talented and skilled people in the right role with the right resources. We provide a clear and strategic direction to achieve superior results on behalf of the communities we serve.
Clinical Metrology Associate
Clinical Research Associate Job In Jacksonville, FL
Kelly Services is currently seeking a Clinical Metrology Associate for one of our top clients in Jacksonville, FL.
Assist in building internal clinical metrology instrumentation to measure the impact of novel soft contact lens technology on vision and comfort.
Essential functions:
Deploy, maintain, and assess performance of clinical metrology instrumentation or methods 70 .
Plan, conduct and document instrument qualifications according to internal procedures.
Identify and map out internal procedures related to instrument qualification and document in workflow. c. Identify need of -and conduct- instrument calibrations.
Assist in developing instrumentation and associated metrics under the supervision of clinicians and vision scientists 20
Monthly report out to stakeholders presentation, documentation
Qualifications:
Education: B.S. in Engineering or Science
Minimum years of experience: 2
Required:
Office Excel, Word .
Preferred:
Experience with statistics.
Experience with optics.
Experience with using and/or building scientific instruments.
Experience with conducting clinical trials.
Strong documentation skill
Able to create work instructions / Aids
Experience using and maintaining vision instrumentation
Experience measuring and qualifying equipment
Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
Why Kelly ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:
Vacation and sick pay
Paid holidays
401(k) plan
Group medical, vision, dental, life, and short-term disability insurance options
Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
Kelly Learning Center offers free courses and trainings
Weekly pay
About Kelly Services
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
Research Donor Coordinator
Clinical Research Associate Job In Tampa, FL
The Research Donor coordinator is responsible for the identification, approach, screening, and triage, of all necessary medical, behavioral, laboratory, and other data to ensure quality research recovery. The coordinator works closely with the Scientific Director and other research staff to coordinate tissue collection with research projects. All Research Donor Coordinators are dedicated to the highest ethical standards and are trained to ensure that tissue is recovered safely with respect and dignity to the donor and their family. All Research Coordinators must be good stewards of the donor's gift and to those who will receive this precious contribution for research.
Essential Duties and Responsibilities
Supports the Mission, Vision and Values of LWVI and exhibits a personal commitment to organ donation
Supports the recovery and placement process for timely delivery of the highest quality research tissue for LWVI customers across potential recovery localities
Performs donor medical history reviews and instructs recovery teams on handling, recovery, and shipment of donor tissue
Telephonic approach of potential donor's next of kin for authorization to recover tissue for research purposes and, upon receipt of authorization, the completion of necessary referral and research donor paperwork
Copies or obtains complete and accurate medical charts, behavioral data, laboratory data, blood specimens, and other pertinent data from the recovery site and other appropriate agencies
Familiarity with Hospitals Policies in our service areas as well as Medical Examiner's Policies
Familiarity with working relationship with Organ Procurement Organization
Familiarity with Countrywide recovery staff and logistics to ensure timely recovery and shipment of potential tissue
Performs EMR reviews as needed
Interacts professionally and respectfully as a representative of LWVI with hospital, funeral home, and transplant/donation facilities
Maintains patient and organizational confidentiality at all times.
Conduct routine research laboratory functions including testing and validation, primary cell culture etc.
Perform all job functions in accordance with applicable state and federal regulations, Eye Bank Associate of American Medical Standards, and LWVI SOPs
Performs other projects and duties as assigned
Education and Experience
Bachelor's degree preferred; work experience in the fields of science and/or allied health care (Surgical Technician, Ophthalmic Technologists, EMT, ER Technician, etc.), background may substitute
Knowledge of ocular anatomy, physiology and disease processes preferred
Experience with donor approach for transplant and or research preferred
Proficiency in iTransplant or similar donor referral software preferred
Knowledge, Skills and Abilities
Excellent oral and written communication skills with the ability to interact effectively with all Eye Bank, hospital and peer agency staff
Knowledge of medical and ophthalmic terminology
Basic research laboratory experience is preferred, though full training will be provided
Be a self-starter and perform work independently
Strong working knowledge of aseptic technique, applicable state and federal regulations, eye Bank Association of America Medical Standards, and LWVI standards operating procedures
Must read and write English
Must have reliable, dependable transportation to and from work.
Effective interpersonal skills
Strong organizational skills and detail-oriented
Must be signed off by DSC for Screening purposes
Ability to adapt to changing technology implemented to stay competitive
Computer software skills, including but not limited to MS Outlook and Word
Compensation and Benefits
$21.00 - 23.70 per hour
Paid time off with a starting maximum of 144.04 hours per year.
8 Company-paid Holidays per year.
Medical, Dental, and Vision plan offerings for employees and their eligible dependents. All Vision plans 100% employer-paid.
Employer-paid Employee Assistance Program, Life, Accidental Death & Dismemberment, Short-Term Disability, and Long-Term Disability plans.
Offerings of Supplemental Life and Accidental Death & Dismemberment for employee and their eligible dependents.
An employee may voluntarily designate a percentage of their salary towards employer-sponsored 401(k). LWVI will match the employee's contribution up to 6% of the employee's salary.
Discounts on Pet Insurance and other items such as phone plans, movie tickets, etc.
Schedule and Travel
The position works at the LWVI offices in Tampa and does not require travel. Expected work shifts are Monday through Friday, 10 AM-7 PM (including a 30-minute lunch break)
Work Environment
The work is performed primarily in an office setting. The noise level in the work environment is moderate. The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related to a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
As an equal opportunity employer, every qualified applicant will be considered for employment. Lions World Vision Institute does not discriminate based on race, color, sex/gender, political ideology, religion/creed, pregnancy, age, physical or mental disability, medical condition, genetic information, marital status, national origin, color, military or veteran's status, sexual orientation, gender identity, or any other status or characteristic protected by local, state, or federal laws. Lions World Vision Institute is committed to a diverse workforce and is also committed to a barrier-free employment process. In order to ensure reasonable accommodations with Title I of the Americans with Disabilities Act of 1990, individuals that require accommodations in the job application process for a posted position may contact us at ************** for assistance. Lions World Vision Institute will use E-Verify once you have accepted the job offer and completed the Form I-9.
Clinical Research Coordinator
Clinical Research Associate Job In Boca Raton, FL
HIGHLIGHTS
Full-time opportunity with consistent weekday schedule (Monday-Friday, 7:00 AM - 3:30 PM)
Comprehensive benefits including health insurance, PTO, and 401k match
Join a thriving research network with long-term growth potential
Hands-on work supporting impactful clinical trials across multiple phases
Collaborative, inclusive, and mission-driven culture
COMPANY
Our client is one of the fastest-growing site networks in the country, with 31 locations across 9 states-and they're not slowing down. With a strong focus on career development, diversity, and advancing medical research, this organization offers a unique opportunity to grow your career while contributing to meaningful, life-changing work.
POSITION
We're seeking a Clinical Research Coordinator to join our client's Boca Raton, FL team. In this role, you'll assist with the execution of clinical trials across various phases and therapeutic areas. You'll work closely with patients, investigators, and sponsors to ensure protocol compliance and a high-quality research experience.
RESPONSIBILITIES
Coordinate and conduct study visits in accordance with protocol, GCP, and regulatory guidelines
Obtain informed consent from study participants and ensure documentation is complete
Perform lab draws, EKGs, specimen processing, and packaging
Manage source documentation, adverse event reporting, and maintain accurate records
Communicate effectively with sponsors and CROs throughout the study lifecycle
Prepare for and participate in site visits, including initiation and monitoring visits
QUALIFICATIONS
2+ years of experience as a Clinical Research Coordinator preferred
Phlebotomy experience is required; EKG or other clinical experience a plus
Strong organizational and documentation skills, with high attention to detail
Familiarity with FDA, ICH-GCP, and electronic source documentation
Strong communication skills and ability to work with diverse teams and patients
Bachelor's degree preferred but not required
Clinical Research Assistant - 240522
Clinical Research Associate Job In Port Charlotte, FL
Clinical Research Assistant - Full-Time
Are you passionate about clinical research and patient care? We're looking for a Clinical Research Assistant to join our team! This role provides direct and administrative support to Clinical Research Coordinators (CRCs) in conducting clinical trials within a fast-paced healthcare setting.
What You'll Do:
Assist with clinical trial activities, including patient scheduling, pre-screening, and regulatory documentation.
Perform routine research visit tasks such as vital signs, EKGs, and medical history documentation.
Ensure compliance with Good Clinical Practices (GCP) and study protocols.
Maintain research records, source documents, and lab supplies in an organized manner.
Support data entry into study-specific electronic data capture (EDC) systems.
Coordinate and prepare for monitoring visits by organizing documentation.
Communicate effectively with research staff, clinical teams, sponsors, and study participants.
Travel to other locations or attend investigator and sponsor meetings as needed.
What We're Looking For:
Education & Experience:
MA certification; a Bachelor's degree in a health-related field is preferred.
2+ years of experience in Human Subjects Research is preferred.
Phlebotomy skills required!
Skills & Competencies:
Strong multitasking and organizational abilities.
Attention to detail with excellent follow-up skills.
Effective communication with internal and external teams.
Ability to work in a fast-paced, collaborative environment.
Details:
Location: Port Charlotte, FL
Hours: Monday - Friday; Normal Business Hours; Onsite 5 Days a Week
Duration: Contract-to-Hire (1040 Hours)
Clinical Research Coordinator RN- Florida Oncology & Hematology
Clinical Research Associate Job In Fort Myers, FL
Pay Range: $26.22 - $48.71 supports Florida Oncology & Hematology in Fort. Myers, FL. Why choose Florida Oncology & Hematology and American Oncology Network? * Shift: Monday- Friday, 8a-5p shift, NO nights, NO weekends, NO major holidays!
* Competitive pay & generous PTO package, plus 6 paid Holidays and 2 "Floater" Holidays.
* Comprehensive Benefits
* Tuition Reimbursement
* 401K Matching
* AON's WellBeing Program
Job Description Summary
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.
Primary Key Performance Areas
KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
* Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.
* Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
* Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently.
* Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs.
* Review and interpret diagnostic test results and related documentation required per protocol.
* Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events.
* Dispense study medication in a professional and accountable manner following protocol requirements.
* Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens.
* Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised.
KPA 2 - Regulatory and Data Integrity
* Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file.
* Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
* Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy.
* Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
* Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests.
* Implement a CAPA assessment and follow CAPA related issues through to resolution.
* Escalates issues of protocol non-compliance to study PI and research department leadership.
KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance
* Assess a protocol and study plan to develop a study budget.
* Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study.
Position Qualifications/Requirements
Education
* High school education required.
* ASN or BSN required.
Certifications/Licenses
* Registered Nurse.
* Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
Previous Experience
* 2-5 years nursing experience required, oncology preferred.
Core Capabilities
* Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
#AONN
* Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
* Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
* Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
* Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.
* Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
Computer Skills:
* Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
* Prior experience with electronic medical records (EMR) is preferred.
* Prior experience with clinical trial data entry systems (EDC) preferred.
* Prior Clinical Trial Management Systems (CTMS) preferred.
Travel: 0%
Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM
Clinical Research Coordinator
Clinical Research Associate Job In Sarasota, FL
Full-time Description
Status: Exempt EEO: Professional Date Revised: 01/12/2023
Statement of Purpose: The Clinical Research Coordinator (CRC) supports, facilitates, and coordinates the daily clinical trial activities under the direction of the Principal Investigator (PI). The CRC coordinates to support and complete the administration of the compliance, financial, personnel and other related aspects of the clinical study. Ensures that the best interests of all participants and the researchers are protected.
Essential Functions:
Coordinates with the PI, and the Director of Clinical Research (DCR); collaborating agencies, administration, and departments to help ensure that the clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures.
Collaborates with the PI and DCR to develop materials and tools necessary to appropriately train study participants in the conduct of the study around issues of protocol requirements, schedule of visits, and compliance. Ensures training is completed and documented according to all requirements
Assists PI and DCR in the communication of study requirements and training compliance to all team members involved in conducting the study.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Assesses, records and reports symptoms, reactions, treatments, and changes in clinical trial participant conditions.
Performs EKG's, Venipunctures, Injections, infusions, and other procedures as required by the clinical research project.
Register participants in the appropriate coordinating center and billing matrix as required.
Coordinate participants tests and procedures.
Collects data as required by the protocol.
Maintains adequate inventory of study supplies.
Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate venue.
Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Coordinates and facilitates monitoring and auditing visits.
Documents and reports all required information and submits all study materials according to policies and procedures set by the sponsoring agencies and company protocol.
Establishes and organizes study files including regulatory binders, study specific source documentation and other materials.
Assists the PI and DCR in study feasibility assessments as requested.
Attends Clinical Research meetings as required or requested by the DCR.
Prepares all study materials as requested by the PI including but not limited to informed consent documents, case report forms, enrollment logs, and drug/device accountability logs.
Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research and adheres to all legal standards of professional practice.
20. Demonstrates courtesy, compassion, and respect in all interpersonal and intra-professional relationships with CAN clients, staff, visitors, and partners.
21. Promotes and practices CAN Community Health Inc's mission and values and follows its policies and procedures.
22. Ensures confidentiality is maintained by entire team regarding patient/client information in accordance with HIPAA, professional and departmental standards.
23. Assisting nearby CAN clinics that are participating in trials.
24. Maintain all Investigator site files, including licenses, CV, and training certificates.
25. Submission of necessary documents to the IRB (initial applications, continuing review, deviations, communications etc.).
Secondary Tasks:
Triage patient phone calls and walk-ins and prioritizes emergencies for medical referral.
Performs medical intake procedures including labs, vital signs and history.
Participates in continuous quality improvement of services rendered to CAN clients.
Develops and fosters networking relationships with community and support resources.
Education/Professional:
RN or BSN preferred, or minimum of a bachelor's degree, Life Sciences or in a health-related field.
CPR Certified
Experience:
Minimum 3- years' experience directly related to the duties and responsibilities specified.
Requirements
Competencies:
Leadership
Strategic Thinking/Problem Solving
Results Driven
Communication
Interpersonal Skills
Decision Making
Computer literate, ability to learn and utilize computer software programs.
Knowledge, Skills and Abilities Required:
Ability to work with minimal supervision.
Ability to research projects.
Excellent people manager, open to direction, suggestions, and commitment to get the job done.
Delegates responsibility effectively.
High comfort working in a diverse environment.
CAN Required Trainings:
Bloodborne Pathogen Annual Training
Hazardous Drug Disposal Training
Stericycle DOT Training
Biohazard Waste Training
HIPAA
HIV/AIDS
CITI Training (GCP, IATA)
Compliance in Research Training
Sexual Harassment
Violence in the Workplace
Health Stream Courses (as assigned)
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, audio visual, telephones, photocopiers, filing cabinets and fax machines.
Physical Requirements:
Neat, professional appearance.
Sedentary- Exerts up to 25 lbs. of force occasionally and/or a negligible amount of force frequently or constantly in lift, carry, push, pull, or otherwise move objects. Involves sitting most of the time but may involve walking or standing for brief periods of time.
Requires expressing or exchanging ideas by means of spoken word, visual and auditory acuity.
Position Type/Expected Hours of Work:
This position may require additional time above normal operating hours and on occasion weekend work.
Travel:
Travel is primary during the business day, although some out-of-area and overnight travel may be expected. Must be able to operate a motor vehicle and have valid insurance and driver's license.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Responsible To: Director of Clinical Research & Chief Medical Officer
CAN Community Health is an equal opportunity employer that is committed to diversity and values the ways in which we are different. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.
Clinical Research Coordinator RN- Florida Oncology & Hematology
Clinical Research Associate Job In Fort Myers, FL
Pay Range:
supports Florida Oncology & Hematology in Fort. Myers, FL.
Why choose Florida Oncology & Hematology and American Oncology Network? • Shift: Monday- Friday, 8a-5p shift, NO nights, NO weekends, NO major holidays!
• Competitive pay & generous PTO package, plus 6 paid Holidays and 2 "Floater" Holidays.
• Comprehensive Benefits
• Tuition Reimbursement
• 401K Matching
• AON's WellBeing Program
Job Description Summary
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.
Primary Key Performance Areas
KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently.
Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs.
Review and interpret diagnostic test results and related documentation required per protocol.
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events.
Dispense study medication in a professional and accountable manner following protocol requirements.
Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens.
Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised.
KPA 2 - Regulatory and Data Integrity
Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file.
Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy.
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests.
Implement a CAPA assessment and follow CAPA related issues through to resolution.
Escalates issues of protocol non-compliance to study PI and research department leadership.
KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance
Assess a protocol and study plan to develop a study budget.
Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study.
Position Qualifications/Requirements
Education
High school education required.
ASN or BSN required.
Certifications/Licenses
Registered Nurse.
Valid state Driver's License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
Previous Experience
2-5 years nursing experience required, oncology preferred.
Core Capabilities
Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
#AONN
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.
Computer Skills:
Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
Prior experience with electronic medical records (EMR) is preferred.
Prior experience with clinical trial data entry systems (EDC) preferred.
Prior Clinical Trial Management Systems (CTMS) preferred.
Travel: 0%
Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM
Clinical Research Assistant, Nurse
Clinical Research Associate Job In Sun City Center, FL
What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position OverviewThe Clinical Research Assistant, Nurse is an entry level research position. This position is responsible for handling Investigational Products (IP) in accordance with study protocols, Good Clinical Practices (GCP), and all other applicable guidelines and regulations including Company Standard Operating Procedures. The Clinical Research Assistant, Nurse will work closely with the Clinical Research Coordinator to complete participant visits.
What You'll Be Working On
Duties include but not limited to:
Patient Coordination· Prescreen study candidates · Obtain informed consent per Care Access Research SOP . · Complete visit procedures in accordance with protocol. · Collect, process and ship specimens as directed by protocol, under the direction of the CRC- Schedule visits with participants, contact with reminders
Conducts delegated clinical tasks (Nurse specific) and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
Clinical Tasks Include: · Receive and properly store investigational products according to the study manual, study protocol, and/or instructions for use. · Prepare pharmaceutical medications for administration including re-packaging and labeling, according to protocol requirements. · Maintain medication and product inventory records including receipt, dispensing, labeling, accountability, and reconciliation of all study products. · Maintain the blinding of all study products, where applicable· Maintain all safety standards within the Investigational Product room · Maintain dispensing records in accordance with regulations and sponsor requirements.· Maintain proper storage and security conditions for all medications and investigational products.· Maintain records of equipment logs in accordance with SOPs; and clean and maintain all equipment and work areas, including sterilization as required.
Documentation· Record data legibly and enter in real time on paper or e-source documents · Request study participant payments · Update all applicable internal trackers and online recruitment systems · Assist with query resolution · Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. · Assist with maintaining all site logs · Assist with inventory and ordering equipment and supplies
Patient Recruitment· Participate in recruitment and pre-screening events (may be at another location)· Identify potential participants by reviewing medical records, study charts and subject database · Assist with preparation of outreach materials. · Assist with recruitment of new participants by conducting phone screenings · Request medical records of potential and current research participants · Actively work with recruitment team in calling and recruiting subjects
Other Responsibilities- Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.- Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.- Maintain effective relationships with study participants and other care Access Research personnel.- Collaborate and communicate effectively with the Clinical Research Team regarding Investigational product preparation and administration.- Attend and participate in meetings- Comply with regulatory requirements, policies, procedures, & standards of practice.
Scope of Role
· Autonomy of Role: Work is performed under general supervision· Direct Reports: No
Physical Requirements
· Physical demands associated with onsite duties include: -Walking-20% -Standing-20% -Lifting-20% -Driving-20%
Travel Requirements
·This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
What You Bring
Knowledge, Skills, and Abilities:· Ability to understand and follow institutional SOPs. · Ability and willingness to work independently with minimal supervision · Ability to learn to work in a fast-paced environment · Excellent communication skills and a high degree of professionalism with all types of people· Excellent organizational skills with strong attention to detail · A working knowledge of medical and research terminology · A working knowledge of federal regulations, Good Clinical Practices (GCP) · Critical thinker and problem solver · Friendly, outgoing personality with the ability to maintain a positive attitude under pressure · Contribute to team and site goals · Proficiency in Microsoft Office Suite · High level of self-motivation and energy Certifications, Education, and Experience:- Clinical Research Experience preferred· Experience mixing medications for intravenous administration preferred· Phlebotomy Experience and Proficiency Required Licenses:- Licensed Practical Nurse or Registered Nurse with a minimum of 1 year of recent experience required· License in good standing in the state to which you are applying required Benefits (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 & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.
Employment StatementCare Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Clinical Coordinator
Clinical Research Associate Job In Fort Myers, FL
Physicians' Primary Care of Southwest Florida is a premier physician owned and managed primary care practice with locations in Cape Coral, Fort Myers, Estero, and Lehigh Acres. We are currently seeking a Clinical Coordinator for our Family Practice Division in For Myers, FL. The schedule is Monday through Friday, Days Only. Our Clinical Coordinators provide leadership and clinical expertise for clinical staff to ensure quality patient care. Act as liaison between administration, site managers, physicians, and clinical staff. Maintain proper education and in-servicing standards. Sample of Duties:
Coordinates the general and technical supervision over department personnel in accordance with office, governmental, and other regulatory standards.
Provide highly visible and supportive leadership to clinical staff.
Recommends and implements departmental policies and procedures. Updates staff on changes.
Participates in the assessment of staffing needs, interviewing and staff recruiting.
Maintains clinical staff schedule.
Evaluates patient care needs. Suggests solutions to patient care crisis problems and complaints.
Monitors competency levels of all clinical staff.
Reviews departmental supply requisitions. Ensures the department has adequate supplies and materials as needed to maintain organization effectively.
EHR super user involved in EHR upgrades, training, and support.
Excellent communication skills and the ability to interact with all levels of the organization
Performance Requirements:
Knowledge of fiscal management and human resource management practices.
Knowledge of health care administration principles.
Skill in written and verbal communication.
Ability to exercise initiative, problem-solving, decision-making.
Ability to work effectively with patients, staff, and the public.
Ability to establish priorities and coordinate work activities.
Regular and reliable attendance required
Education:
High School Diploma or GED.
Graduation from an accredited school of practical nursing
Certificate/License:
A Valid current state of Florida License to Nursing (LPN).
CPR certification required (or ability to obtain certification within six months of employment.)
Experience:
Three years of office management experience including one year of supervisory level experience.
Electronic Health Records experience preferred.
PPC Offers:
Over 28 years of serving our Southwest Florida community
Award-winning physicians
Ability to advance and grow within our organization
Health, dental, vision, disability and life insurances
401(k) with company match
Free financial advising
Paid Time Off (PTO)
Paid holidays
Uniform allowances at hire and each anniversary
Reimbursement for position required certifications and/or license
Employee Assistance Program (EAP)
Employee Resource Assistance Program (ERAP)
Discounted legal and document services
Milestone gifts
Employee appreciation events and gifts
Want to learn more about Physicians' Primary Care of Southwest Florida? Visit us at *************** and apply today! Physicians Primary Care of SWFL participates in E-Verify. Go to https://***************/wp-content/uploads/2023/06/E-Verify_Participation_Poster_Eng_Es-06.22.23.pdf for more information.
Clinical Research Assistant
Clinical Research Associate Job In Tampa, FL
At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.
K2 is seeking a Clinical Research Assistant for our Tampa, FL clinic. The Clinical Research Assistant will:
Support clinical trial performance and conduct congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.
Primary Responsibilities:
• Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
• Assist the Site Director and Project Management team on projects as needed
• Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
• Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator
• Articulate all pertinent issues to the Pl or document by email/letter or during meetings
• Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
• Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor{s), Auditors and any marketing groups hired by the Sponsor
• Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at Compass Research
• Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
• Maintain timely K2 Medical Research source documentation as well as sponsor required information.
• Dispense and maintain accurate records of study medication
• Educate patients and family regarding their study and clinical drug trials in general.
• Complete all monitor and sponsor queries in a timely manner
• Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study
Knowledge, Skills, and Abilities:
• Outstanding verbal and written communication skills
• Excellent interpersonal and customer services skills
• Strong time management and organizational skills In depth knowledge of industry regulations
• Proven ability to and foster mentoring relationships
• Ability to create momentum and foster organizational change
Qualifications:
• HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
• Prior experience in a clinical environment preferred. Experience in clinical research is ideal.
• LPN, RN, or other medical licensure or certification preferred.
• Applicants that don't meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be consider.
At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:
Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.
Clinical Research Assistant (HWD)
Clinical Research Associate Job In Boca Raton, FL
Job Details Skin Care Research (SCR) - Boca Raton, FL Full Time 4 Year Degree Negligible Day Health CareDescription
Clinical Research Assistant will perform work in one or all of the following areas Phlebotomy, Data Entry, and Administrative Assistant responsibilities in support of the clinical research team. The Clinical Research Assistant will assist in the management of multiple clinical trials according to the study protocol, perform collection of clinical data points, and provide seamless customer service to the patients attending the site.
Responsibilities Include but not limited to:
Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA
Ensure compliance with all clinical trial protocols
Ensure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA.
Assist research staff with Phase II-IV clinical trials from start through closure
Enter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS)
Aid research department is meeting contracted and expected recruitment goals
Engage in quality assurance of all study documents and data prior to monitoring visits
Support central and local marketing campaigns by entering recruitment data, contacting patients and scheduling.
Coordinate office visits for trial participants based on the protocol
Perform phlebotomy, collect, process and ship clinical specimens
Assist in patient care visits and procedures according to protocol
Receive medication, confirm temperature in range and maintain temperature logs
Perform ECGs
Engage in patient recruitment
Assist with entry into Electronic Data Capture (EDC) data queries are resolved
Participate in Investigator meetings and trainings during the course of the trial
Generate PowerPoint presentations
Create and organize new patient charts, lab and other required supplies prior to the patient visit.
Gain access to Institutional Review Boards.
Maintain regulatory binders, CRFs, subject charting, and source documents
Maintain the Investigator Site Files
Assist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) current
Will support central and local marketing campaigns by contacting potential subjects and scheduling
And all other duties as assigned
Qualifications
Possess a minimum of two (2) years experience in the clinical research or closely related field
Bachelors degree or relevant work experience.
Bilingual (Spanish), a plus.
Clinical Research Assistant
Clinical Research Associate Job In Tampa, FL
Clinical Research Assistant Gastro Florida - Tampa, Florida
We are seeking a detail-oriented and dedicated Clinical Research Assistant to join our expanding research department. The successful candidate will play a vital role in supporting our clinical research team in the planning, execution, and documentation of various clinical trials for gastrointestinal conditions including Crohn's Disease, Ulcerative Colitis, IBS, and liver disorders. This position offers an exceptional opportunity to contribute to groundbreaking research that directly improves patient care while working alongside top specialists in the field.
Key Responsibilities:
Assist in recruiting, screening, and enrolling study participants according to protocol criteria
Coordinate and schedule study visits and participant follow-ups
Collect, process, and manage biological samples and study data
Maintain accurate and detailed records of all research activities
Ensure compliance with regulatory requirements and ethical standards
Assist in preparing study-related documents and reports
Support the principal investigators and research coordinators in daily activities
Monitor study progress and report any protocol deviations
Communicate with research participants to address questions and concerns
Assist in coordinating with other departments involved in trials
Qualifications:
Bachelor's degree in life sciences, nursing, or related field (required)
1-2 years of clinical research experience (preferred)
Knowledge of GCP (Good Clinical Practice) guidelines and ICH regulations
Excellent organizational, time management, and multitasking abilities
Strong attention to detail and accuracy in data collection and entry
Proficiency in Microsoft Office and clinical research databases
Effective written and verbal communication skills
Ability to work independently and as part of a collaborative team
Experience with gastroenterological conditions (a plus)
ACRP or SoCRA certification (a plus)
What We Offer:
Competitive salary and comprehensive benefits package
Professional development opportunities and potential for career advancement
Work with leading gastroenterologists who are pioneers in clinical research
Exposure to cutting-edge treatments and technologies
Collaborative and supportive work environment
The satisfaction of contributing to medical advances that improve patient care
Clinical Assistant Nurse Manager - Dr. P. Phillips Hospital (Nights)
Clinical Research Associate Job In Orlando, FL
Department: B6 Unit Status: Full-time Shift: Night Title: Clinical Assistant Nurse Manager ORLANDO HEALTH DR. P. PHILLIPS HOSPITAL Orlando Health Dr. P. Phillips Hospital is an award-winning, full-service medical/surgical facility that has been serving the residents of southwest Orange County and Orlando's growing tourist population since 1985. With a highly qualified team of nurses, support staff and physician specialists, our 285-bed facility provides combined expertise and advanced technology in numerous areas of specialty, including diagnostic imaging, cardiovascular care, orthopedic care, surgical services and emergency medicine. The hospital is equipped with robotic surgical capabilities for colorectal, general, gynecologic and urologic surgeries and has earned Joint Commission certification for its total hip and knee replacement programs utilizing innovative, personalized technologies. Orlando Health Dr. P. Phillips proudly holds recognition as a "Best Regional Hospital" by U.S. News & World Report. Orlando Health Dr. P. Phillips is part of the Orlando Health system of care, which 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 and beyond. Collectively, our 27,000+ team members honor our over 100-year legacy by providing professional and compassionate care to the patients, families and communities we serve. 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 proudly embraces and honors the individuality of our team members. By sharing different ideas and perspectives and working together as a team, we are better able to relate to, care for and authentically serve our patients and families who make up the collective populations in our community. So, no matter who you are, what you believe or how you express yourself, you are welcome here. "Orlando Health Is Your Best Place to Work" is not just something we say, it's our promise to you. Top Reasons to Choose Orlando Health - Dr. P. Phillips Hospital: Competitive Pay: Evening, nights, and weekend shift differentials offered for qualifying positions. All Inclusive Benefits: Student loan repayment, tuition reimbursement, back up elder and childcare, pet insurance, and more for full time and part time employees. Employee-centric: P. Phillips Hospital has been selected as one of the 2020 "Best Places to Work in Healthcare" by Modern Healthcare. Committed to Community: Orlando Health provides more than $450 million in total value to the community in the form of charity care, community benefit programs and services, community building activities and more. Forbes Recognizes Orlando Health as a Best-In-State Employer Forbes has named Orlando Health as one of America's Best-In-State Employers for 2021. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, vice president, Human Resources. "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Responsibilities The Clinical Assistant Nurse Manager (CANM) isresponsible for leading the shift operations within the clinical setting to ensure delivery of high-quality care, exceptional customer experience, and optimal patient flow. In conjunction with the Department Nursing Operations Manager and the Assistant Nursing Operations Manager (ANOM); the CANM provides guidance, fosters collaboration, and is responsible for the unit's clinical operations including patient care assignments, customer experience, productivity, and quality outcomes in settings where an acute care patient receives active treatment for an injury, episode of illness, a medical condition, or post intervention with assessment Essential Functions • Exemplar of the mission, vision, and values of Orlando Health. • Participates in shared leadership structure. • Managesstaffing assignments for oncoming and off going shifts, based on patient acuity and skill set of team members to ensure patient care needs are met. • Coordinates patient flow by working directly with the Administrative Supervisors, Care Coordinators, and Discharge Planners to achieve expected outcomes. • Monitors overall status of patients within area ofresponsibility and closely monitors status ofseriously ill patients. • Coordinates and/or participatesin the delivery of patient care ensuring compliance with physician orders and established policies, procedures, and standards ofpractice. • Serves as a resource supporting frontline team members and providers as appropriate. • Supports clinical collaboration focusing on expected patient length of stay. • Performs direct patient care activities as required to meet operational needs. • Interfaceswithpatients andfamiliesto enhance customer experience by conducting Nurse Leader rounds and investigating and responding to patient/family and physiciancomplaints. • Participates in and/or leads safety huddles. • Embraces, communicates, and promotes change and problem solving. • Assesses equipment needs to ensure staff have the needed equipment for patient care, and they can appropriately utilize equipment. • Supports and sustains all leader-driveninitiatives. • Assists with retention strategies for new team members that fosters a best place to work environment. • Maintains a regulatory ready environment of care. • Ensures the appropriate allocation/adjustment of staff, assignment of meal breaks, relief of team members as indicated, etc. • Utilizes effective fiscal management skills and financial resources with decision-making. • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA, and other federal, state, and local standards. • Maintains compliance with all Orlando Health policies and procedures. Qualifications Education/Training • Bachelor of Science in Nursing Degree (BSN) preferred. Licensure/Certification • Current licensure as a registered nurse in the State of Florida or Nurse Licensure Compact (NLC). • Current Basic Life Support (BLS) certification. • Certification in area of expertise; preferred. • May require one or more of the following certifications based on the assigned patient population: o Advanced Cardiovascular Life Support(ACLS) o Pediatric Advanced Life Support (PALS) o Neonatal Resuscitation Program (NRP) o Trauma Nurse Core Course (TNCC) Experience A minimum of one year of experience as a Registered Nurse; acute care setting preferred
Education/Training • Bachelor of Science in Nursing Degree (BSN) preferred. Licensure/Certification • Current licensure as a registered nurse in the State of Florida or Nurse Licensure Compact (NLC). • Current Basic Life Support (BLS) certification. • Certification in area of expertise; preferred. • May require one or more of the following certifications based on the assigned patient population: o Advanced Cardiovascular Life Support(ACLS) o Pediatric Advanced Life Support (PALS) o Neonatal Resuscitation Program (NRP) o Trauma Nurse Core Course (TNCC) Experience A minimum of one year of experience as a Registered Nurse; acute care setting preferred
Position Summary The Clinical Assistant Nurse Manager (CANM) isresponsible for leading the shift operations within the clinical setting to ensure delivery of high-quality care, exceptional customer experience, and optimal patient flow. In conjunction with the Department Nursing Operations Manager and the Assistant Nursing Operations Manager (ANOM); the CANM provides guidance, fosters collaboration, and is responsible for the unit's clinical operations including patient care assignments, customer experience, productivity, and quality outcomes in settings where an acute care patient receives active treatment for an injury, episode of illness, a medical condition, or post intervention with assessment Essential Functions • Exemplar of the mission, vision, and values of Orlando Health. • Participates in shared leadership structure. • Managesstaffing assignments for oncoming and off going shifts, based on patient acuity and skill set of team members to ensure patient care needs are met. • Coordinates patient flow by working directly with the Administrative Supervisors, Care Coordinators, and Discharge Planners to achieve expected outcomes. • Monitors overall status of patients within area ofresponsibility and closely monitors status ofseriously ill patients. • Coordinates and/or participatesin the delivery of patient care ensuring compliance with physician orders and established policies, procedures, and standards ofpractice. • Serves as a resource supporting frontline team members and providers as appropriate. • Supports clinical collaboration focusing on expected patient length of stay. • Performs direct patient care activities as required to meet operational needs. • Interfaceswithpatients andfamiliesto enhance customer experience by conducting Nurse Leader rounds and investigating and responding to patient/family and physiciancomplaints. • Participates in and/or leads safety huddles. • Embraces, communicates, and promotes change and problem solving. • Assesses equipment needs to ensure staff have the needed equipment for patient care, and they can appropriately utilize equipment. • Supports and sustains all leader-driveninitiatives. • Assists with retention strategies for new team members that fosters a best place to work environment. • Maintains a regulatory ready environment of care. • Ensures the appropriate allocation/adjustment of staff, assignment of meal breaks, relief of team members as indicated, etc. • Utilizes effective fiscal management skills and financial resources with decision-making. • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA, and other federal, state, and local standards. • Maintains compliance with all Orlando Health policies and procedures.
Clinical Research Assistant
Clinical Research Associate Job In Fort Lauderdale, FL
Job Details RCA-HOSPITAL - FORT LAUDERDALE, FL Full Time Any ResearchJob Description
Function: The position trains with other clinical research staff and works directly with physicians to conduct clinical research trials, recruit and consent subjects, and collect and verify accuracy of data. The incumbent also assists in designing clinical trials and skill operationalizing a clinical trial in a clinical study; conducts human subject research involving multiple study sites; ensures IRB compliance; and provides communication to the Principal Investigator.
Principal Duties & Responsibilities:
Assist in data management, regulatory paper works and other local administrative tasks as supervised by the clinical research coordinator
Coordinate research and administrative activities, ensuring all projects are completed according to project/study timelines
Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, Institutional Review Board (IRB), grant/contract and study and site specifications
Recruit study participants and complete structured clinical assessments with participants
Monitor and promptly respond to participant queries
Collect and track study data and compile data reports
Submit and maintain proper study records, including submission of timely reports to Institutional Review Boards
Produce special and recurring reports
Other Duties as Assigned:
The above information on this portion is designed to present the most essential duties and responsibilities necessary to achieve the positions end results. The occupant of this position is required to follow any other job-related instructions and perform any other duties as requested by Physician Director(s), Clinical Research Manager, and/or Practice Manager. It is the responsibility of each employee to assist other office staff when and where necessary. All employees have the responsibility of answering phones, maintaining files, filing, updating data, and receiving prescription refill orders, etc. Most importantly, it is each staff member's responsibility to project and maintain a positive attitude toward all patients and fellow co- workers. The duties listed may be changed or modified at any time.
Qualifications
Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
Knowledge of medical terminology
Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
Familiarity with the Microsoft Office Suite
Previous work with CRFs and EDC
Excellent organizational skills to independently manage work flow
Ability to prioritize quickly and appropriately
Ability to multi-task
Meticulous attention to detail
Education and Experience:
Licensed candidates must have an Associate's degree and RN or LPN licensure
One year of experience working in clinical research is preferred
Psychology background preferred
Clinical Research Assistant / Medical Assistant
Clinical Research Associate Job In DeLand, FL
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.
Key Responsibilities
Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:
* Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
* Assists with the basic screening of patients for study enrollment;
* Assists with patient follow-up visits;
* Documents in source clinic charts;
* Enters data in EDC and answers queries;
* Obtains vital signs and ECGs;
* May perform blood draws;
* Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
* Request and track medical record requests;
* Enters data in EDC and answers queries;
* Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
* Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
* Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
* Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
* Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
* Perform all other duties as requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
* Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
* Must possess strong organizational skills and attention to detail.
* Well-developed written and verbal communication skills.
* Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
* Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
* Must be professional, respectful of others, self-motivated, and have a strong work ethic.
* Must possess a high degree of integrity and dependability.
* Ability to work under minimal supervision, identify problems and implement solutions.
* Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
* Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
* Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.