Clinical Medicine Researcher
Clinical Research Coordinator Job 112 miles from North Port
Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Clinical Medicine Expert who would like to lend your expertise to train AI models?
About the opportunity:
Outlier is looking for talented Clinical Medicine Experts to help train generative artificial intelligence models
This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you
You may contribute your expertise by…
Assessing the factuality and relevance of domain-specific text produced by AI models
Crafting and answering questions related to Clinical Medicine
Evaluating and ranking domain-specific responses generated by AI models
Examples of desirable expertise:
A bachelor's or higher degree in Clinical Medicine or a related subject
Experience working as a Clinical Medicine professional
Ability to write clearly about concepts related to Clinical Medicine in fluent English
Payment:
Currently, pay rates for core project work by Clinical Medicine experts range from $25 to $45 per hour USD.
Rates vary based on expertise, skills assessment, location, project need, and other factors. For example, higher rates may be offered to PhDs. For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project.
Clinical Research Manager 182825
Clinical Research Coordinator Job 141 miles from North Port
We are looking to add a Site Manager to our growing team. This person would be responsible for overseeing 2 sites focused on Medical Device and Therapeutic clinical trials. This is a full time onsite role with lots of room for growth, fantastic benefits and the opportunity to join a large national organization that is changing the future of therapeutics.
Job Description
A Site Manager in clinical research plays a crucial role in overseeing and managing clinical trial sites within a specific geographic area. Their responsibility spans from site selection to ensuring that clinical studies are conducted in compliance with regulatory standards and study protocols.
Responsibilities:
Oversee and monitor the day-to-day operations of clinical trial sites in the region.
Ensure that the sites adhere to protocol requirements, Good Clinical Practice (GCP), and regulatory guidelines.
Provide support to sites during the initiation, monitoring, and close-out phases of the trial.
Track and assess site performance, including enrollment rates, data quality, and adherence to study timelines.
Troubleshoot issues related to recruitment, protocol deviations, and site performance.
Provide feedback to the site team and implement corrective actions when necessary.
Serve as the primary point of contact between the sponsor or Clinical Research Organization (CRO) and the clinical trial sites.
Foster strong relationships with site staff, investigators, and other stakeholders.
Conduct regular site visits and virtual meetings to ensure smooth communication and site support.
Train site personnel on clinical trial protocols, data collection processes, and compliance procedures.
Provide ongoing support to site staff to resolve operational issues or concerns.
Ensure the timely submission of regulatory documents, including Institutional Review Board (IRB) submissions, informed consent forms, and other required paperwork.
Ensure that essential study documentation is maintained accurately and in accordance with GCP and regulatory guidelines.
Conduct routine site monitoring visits and assessments, ensuring sites are operating within protocol requirements.
Prepare and submit regular progress reports to the Clinical Operations team or sponsor.
Assist in resolving any issues that arise during monitoring visits and recommend solutions.
Identify potential risks related to site management and proactively address issues to minimize study delays.
Ensure that corrective actions are implemented at sites as needed.
Qualifications
Education: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
Experience: Minimum of 3-5 years of experience in clinical research, particularly in site management or clinical operations.
Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred.
Skills:
Strong understanding of clinical trial protocols, GCP, ICH guidelines, and regulatory requirements.
Excellent communication, interpersonal, and organizational skills.
Ability to manage multiple sites and tasks simultaneously.
Ability to work independently with minimal supervision.
Strong problem-solving and troubleshooting abilities.
Preferred Qualifications:
Experience in managing multi-site clinical trials
Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
Senior Clinical Research Associate
Clinical Research Coordinator Job 109 miles from North Port
As a Senior CRA (ONC) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Roles and Responsibilities:
Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
Develops meaningful site relationships through consistent collaborative communication and engagement.
May participate in site feasibility and/or pre-trial site assessment visits.
Attends/participates in investigator meetings as needed.
May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible
Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
Ensures site non-IMP study supplies are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
Oversees the appropriate destruction of clinical supplies.
Ensures site staff complete data entry and resolve queries within expected timelines.
Ensures validity and completeness of data collected at trial sites.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
Prepares trial sites for close out, conduct final close out visit.
Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
Required Qualifications:
BA/BS degree with ≥5years of experience in pharmaceutical related drug development.
Five years site monitoring and/or site management experience.
A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong critical thinking and problem solving skills.
Strong IT skills in appropriate software and company systems.
Willingness to travel up to 40% with overnight stay away from home.
Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
Good written and oral communication.
Preferred Qualifications:
Experience working cross-functionally and in matrix teams
Experience in executing Lead CSM role
Experience mentoring more junior site monitors or site managers
Experience working in early development studies
Clinical Research Coordinator
Clinical Research Coordinator Job 63 miles from North Port
IPTB Clinical Research is a neuropsychiatric-focused clinical trials site that addresses a range of conditions including Depression, Schizophrenia, Anxiety Disorders, Bipolar Disorder, Peripartum Mood Disorders, and Alzheimer's Disease.
Role Description
This is a full-time, on-site role in South Tampa, FL. Starting Salary: $66K-70K per year with benefits and the opportunity to grow within the company. The Clinical Research Coordinator will oversee the day-to-day operations of clinical trials, ensuring that they are conducted smoothly and in compliance with protocols. Responsibilities include obtaining informed consent from participants, managing study protocols, collecting and recording data, coordinating with healthcare professionals, and ensuring that all aspects of the research adhere to regulatory requirements.
Qualifications
Experience with obtaining Informed Consent
Strong understanding of Clinical Trial Protocols
Background in Research and Clinical Research Experience
Experience managing Clinical Trials
Excellent organizational and communication skills
Attention to detail and ability to adhere to strict guidelines
Bachelor's degree in a related field such as Nursing, Psychology, or Life Sciences
Certification in clinical research is a plus
Clinical Coordinator Medical Surgical
Clinical Research Coordinator Job 132 miles from North Port
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.
63037 Coordinator Social Studies
Clinical Research Coordinator Job In Florida
Administration
Date Available: 07/28/2025
The Monroe County School District (MCSD) is looking for a dynamic, highly qualified individual with strong leadership skills to take the helm as the Coordinator Social Studies. The MCSD administrative building is located in beautiful Old Town Key West and offers successful candidates the opportunity to work and live in a tropical paradise.
The essential function of the position within the organization is to provide professional leadership, consultation and support of the District's Social Studies teachers in assigned grade levels to ensure the provision of effective classroom instruction. The position is responsible for supporting teachers and administrators in meeting identified goals in social studies programs, assisting schools in obtaining necessary classroom materials and other resources, assisting in the development and implementation of special programs and services as assigned, and performing related professional and administrative duties as required. The position develops and implements programs within organizational policies; reports major activities to executive level administrators through conferences and reports.
Masters or Doctorate degree preferred. Bachelor's degree required.
Florida professional certificate in Educational Leadership preferred. FL educator certification in Social Science is required.
Salary Range: $74,800-$105,300
Salary Slot: CC
Days per year: 220
Hours per day: 8
Attachment(s):
63037 Coordinator Social Studies.pdf
Clinical Research Scientist
Clinical Research Coordinator Job 63 miles from North Port
Job Title: Clinical Research Scientist
Job Contract Type: Full-time
Job Seniority Level:
The Clinical Research Scientist provides clinical support to Clinical Development/Medical Teams for clinical/medical issues that impact the full clinical development spectrum for the assigned product. The job will include involvement in the design of clinical development materials (plans, protocols, investigator brochures, etc) as well as assisting the Medical Lead in clinical trial conduct, including data review (data queries, evaluating data integrity and assist in safety data surveillance), and site, vendor or investigator interactions for ongoing clinical trials. The position will work seamlessly with Clinical Operations, Pharmacovigilance, Data Management, Biometrics and Regulatory Affairs as well as other groups within the organization (Commercial, Business Development) to assist the Clinical Development/Clinical Affairs Team and ensure the appropriate dispersal of information within the company and, as necessary, with external advisors. It requires an understanding of the therapeutic context of the clinical program and to be able to be an integral part relevant discussions with sites, investigators, and vendors.
Responsibilities
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Manage the clinical development function to ensure that clinical research activities are conceived, planned, and implemented in a timely manner to achieve corporate goals.
Assist with the preparation and upkeep of appropriate documents, including protocols, amendments, investigator's brochures, SOPs, case report forms, clinical aspects of regulatory submissions, literature reviews, scientific papers, and presentations.
Assist in all relevant clinical aspects of study design, with appropriate support as needed.
Partner with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting
Will play a crucial part in ensuring the accuracy, integrity and completeness of clinical trial data. Identify and resolve discrepancies or errors in clinical trial data and assist Data Management with the review of clinical data and query resolution.
Ensure compliance with regulatory requirements and company standards, contribute to the development and implementation of data review processes and procedures, collaborate with cross-functional teams to ensure timely and accurate data review
Assist with medical monitoring and reporting in partnership with Study Responsible Physician, assist in evaluating clinical trial adverse events, review clinical laboratory results, draft adverse event narratives.
Assist in the safety review of all products including those in the experimental phase of development and in the post marketing phase. Assist in providing scientific input to all relevant documents as necessary throughout the product development life cycle
Build relationships with clinical investigators, medical/scientific experts in partnership with Study Responsible Physician
Assist company representatives at steering committee, academic, medical industry and regulatory meetings.
Embrace a teaching role in investigator meetings and in-house education as appropriate.
Assists in medical literature reviews and related activities
Assist in the execution of clinical studies to meet objectives of the study and Clinical Development Program
Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials in partnership with Study Responsible Physician
Actively participate in study management with the cross functional clinical team (Clinical Operations, Pharmacovigilance, Data Management, Biostatistics and Regulatory Affairs) to ensure the team will achieve key study milestones including timeline and ensure high data quality from the clinical studies assigned.
Interface with project team members including Clinical Operations, Data Management, Biostatistics, Pharmacovigilance and Regulatory Affairs.
Assist with study vendor selection and education.
Supervisory Responsibilities:
This position typically does not have supervisory responsibility.
Interaction:
The position works most closely with the Sr Medical Director but may also interact with clinical operations staff, pharmacovigilance staff, regulatory staff, and CROs to assure the timely and effective medical oversight of clinical studies
Qualifications
Education and Experience:
Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
Minimum of 10 years clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
Minimum of 5 years of pharmaceutical clinical/medical data/safety review experience
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, And Abilities:
Experience in designing and conducting clinical trials, including medical data review
Knowledge of all aspects of the drug development process.
Working knowledge of GCP/ICH Guidelines and other relevant clinical development regulations and processes.
Ability to work both independently and with multidisciplinary teams.
Experience working in a team/matrix entrepreneurial environment with a “roll up the sleeves” approach.
Excellent planning, organizing, and executing skills.
Proven ability to be results driven and consistently meet deadlines.
Excellent written and oral English communication and presentation skills.
Willingness to travel up to 30%
This position may require on-site presence at clinical trial sites when feasible.
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This is a remote position and will require on-site presence at clinical trial sites when feasible, as well as travel to for internal/team meetings.
Benefits
Benefits:
Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental Leave
EEO Statement
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
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Clinical Research Associate I - Center for Rehabilitation Sciences Research
Clinical Research Coordinator Job 353 miles from North Port
Overview Join the HJF Team! HJF is seeking a Clinical Research Associate I to provide human subjects research support, data entry and analysis, and showcase studies in support of the NAVSCOLEOD. This position will be in support of NCAA/DoD Concussion Assessment Research and Education Consortium project supporting the Center for Rehabilitation Sciences Research at the Naval School Explosive Ordnance Disposal (NAVSCOLEOD).
This position is located on-site at Elgin Air Force Base, Florida.
The Henry M.
Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine.
We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.
HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities Verifies and corrects data entry for research projects, supports senior staff in quality control and provides troubleshooting.
Maintains clear and accurate records, inventories and logbooks.
Recruits and consents participants to research projects.
Assists with the preparation of technical reports, summaries and protocols.
Provides written updates to senior staff.
Assists the team on program/project improvement initiatives and may provide support the development, reporting and analysis of study/ program performance through relevant metrics.
Contributes to poster/ presentations/ manuscript development.
Other duties as assigned.
Qualifications Education and Experience Master's Degree required.
Minimum of 0 to 2 years experience required.
Required Knowledge, Skills and Abilities Research and human subjects experience.
May participate in drawing participant blood as needed.
General understanding of how research studies are conducted and be able to provide support to the development, reporting, analysis, and summarizing of studies.
Able to support meetings with internal and external partners.
This includes the selection and recruitment of presenters and topics, reviewing and or creating presentations, facilitating and monitoring meetings, creating summary documents, and dissemination of information.
Able to coordinate document submissions, create and maintain accurate records, and communicate well with the network, HQ, Gov, and other stakeholders.
Ability to perform/understanding of: data collection, document review/quality control checks, basic data interpretation, literature review, preparing and presenting summaries to the group.
Able to contribute to posters, presentations, manuscript development.
Desire and interest to work in the traumatic brain injury research field.
(Background in brain injury, neurology, or similar topic is a preference.
Previous experience with military or government research is a preference).
Familiar with IRB activities, Human Research Protection Program (HRPP) and grants management preferred.
Ability to obtain and maintain a T3/Secret Clearance.
Physical Capabilities Lifting: Requires lifting materials up to 25 lbs.
Ability to stand or sit at a computer for prolonged periods.
Work Environment This position will take place primarily in an office setting.
Compensation The annual salary range for this position is $50,100- $65,000/year.
Actual salary will be determined based on experience, education, etc.
Benefits HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Clinical Research Coordinator RN- Florida Oncology & Hematology
Clinical Research Coordinator Job 38 miles from North Port
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
Study Coordinator
Clinical Research Coordinator Job 109 miles from North Port
It's More Than a Career, It's a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.
You will lead the execution of trials for the research team
You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out
You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians
You will verify study procedures are performed within the protocol specified window
You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff
You will present in weekly protocol meeting to investigators, research staff, and management
You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria
You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)
You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes
You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions
You will ensure pharmacy has Investigative Product and supplies
You will interface with laboratory technician for lab kits and processing
You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations
You will participate in monitor visits for each assigned trial at each monitoring visit
You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items
You will review source documentation and queries for missing documentation
You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe
You will maintain case report forms tracking management database
You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance
You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning
You will review and responds to audit findings and escalates issues
You will maintain and archive study documentation and correspondence per company policy
You will reports patient visit and data entry information in financial tracking system.
You will provide required metrics to leadership
You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
You will adhere to professional standards and SOP's established for clinical research
You will assist internal quality team in preparation for sponsor and US FDA audit teams
You should have for this role:
An understanding of clinical trial data.
Knowledge of FDA guidelines and GCP is required.
The ability to work independently in a fast paced environment.
Interpersonal skills, detailed-oriented and meticulous.
Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel
Bachelor Degree is preferred
At least one year of experience in healthcare, research or other science related field
At least one year of experience planning and managing clinical trial process
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Clinical Research Coordinator RN- Florida Oncology & Hematology
Clinical Research Coordinator Job 38 miles from North Port
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 Data Coordinator
Clinical Research Coordinator Job 109 miles from North Port
Clinical Research Data Coordinator I is primarily responsible for the completeness, timely delivery, and quality of clinical research data via data entry. In this role, the Clinical Research Data Coordinator I collaborates with study Investigators, Clinical Research Coordinators (CRC), study sponsors, and other research and clinical team members in the conduct of Phase I-IV industry-sponsored, grant-funded (federal or other grants), and/or investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations, and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) Guidelines. The coordinator will meet study-specific goals and timelines and assist the study team with the operational needs of specific protocols. This position actively contributes to outstanding customer service and maintains respectful relationships with all stakeholders.
Responsibilities
* Manage and ensure accurate and timely retrieval and electronic data entry submission of protocol-driven data points to relevant research sponsors/organizations within the specified time frame.
* Abstract and record essential physical and test data from internal and external sources.
* Maintain a tracking system of study participants at relevant time points as deemed necessary.
* Actively contribute toward tasks related to site monitor visits and/or audits conducted by the institution, industry sponsors, the FDA, and other authorities.
* Correspond with personnel at external institutions to ensure that data from outside institutions are obtained on time and as specified by the protocol.
* Actively contribute to the training and onboarding of Research Support Assistants.
* Instruct trainees in proper data documentation and review the work of trainees for accuracy to ensure data entry is conducted properly and completely.
* Support the research team by creating/maintaining accurate files; copying, scanning, uploading, faxing, and emailing documents as necessary.
* Be proactive in process improvement ideas.
* Perform other duties as assigned or directed to ensure business needs are met for the department or section.
Essential Skills
* Proficiency in data entry and data management.
* Experience in clinical research.
* Knowledge of EDC (Electronic Data Capture) systems.
* Understanding of clinical data management.
* Strong attention to detail and accuracy.
* Excellent organizational and time management skills.
Additional Skills & Qualifications
* Bachelor's degree in healthcare-related field, data processing, or related field, OR
* Associate degree in health science or related field, and one (1) year of administrative/professional experience with data-related responsibilities or clinical research experience, OR
* Graduate of an accredited allied health certificate program and two (2) years of administrative/professional experience with data-related responsibilities or clinical research experience, OR
* Two (2) years of direct clinical research data entry experience OR three (3) years of equivalent administrative/professional experience working with data or medical information, including duties such as data collection, management, and verification.
Work Environment
The role will be based onsite at the corporate office building and will not require visits to the hospital. The work environment is professional, with access to necessary technologies and equipment to perform the job effectively.
Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for next step information.
Pay and Benefits
The pay range for this position is $28.00 - $28.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Orlando,FL.
Application Deadline
This position is anticipated to close on Apr 4, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Clinical Research Coordinator
Clinical Research Coordinator Job 227 miles from North Port
The Center for Healthcare Delivery Science (CHDS) at Nemours Children's Health in Florida is seeking a full-time Clinical Research Coordinator (CRC).
The CHDS is a research center across the Nemours enterprise. Anne E. Kazak, Ph.D., ABPP is the enterprise director, Melissa A. Alderfer, PhD is the Center Director in Delaware and Susana R. Patton, PhD, ABPP is the Center Director in Florida. The CHDS includes 20+ investigators who study ways to improve health care, health equity, and health and wellness beyond medicine for youth and their families. Research projects span a variety of medical conditions (e.g., diabetes, cancer, cardiac conditions, obesity, sickle cell disease, cystic fibrosis, pain, asthma) and other health-related challenges (COVID-19 vaccine hesitancy, homelessness, maternal post-partum depression, racism).
This position is based at Nemours Children's Hospital - Florida in Jacksonville.
The CRC will be responsible for coordinating, implementing and completing research functions associated with studies in the CHDS. Essential CRC duties include coordinating IRB submissions, recruiting study participants, obtaining informed consent, interacting with youth, young adults and parents related to research projects, scheduling and conducting study procedures, collecting and recording study data, organizing participant payments, maintaining study records, participating in data collection and analysis, and the preparation of scientific presentations, manuscripts, reports, and grants.
Position Requirements:
Minimum of a bachelor's degree in psychology, pre-med, public health, or related.
Must be able to effectively use Microsoft computer software, SPSS, and REDCap.
Must be able to coordinate and establish priorities among diverse tasks.
Previous research experience, including qualitative interviewing strongly preferred
Clinical Research Coordinator - CCT
Clinical Research Coordinator Job 133 miles from North Port
GENERAL SUMMARY: The Clinical Research Coordinator will coordinates and execute daily clinical research activities according to the company's SOPs, GCP and FDA guidelines. The Clinical Research Coordinator III is responsible for identifying and promoting the enrollment of all protocol eligible patients for assigned clinical studies.
This position will assist the SOM in providing training to new Clinical Research Coordinators.
Clinical Research Coordinator - Bilingual
Clinical Research Coordinator Job 117 miles from North Port
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 Bilingual 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)
Compensation: $28/hr - $31/hr + comprehensive benefits, PTO, and 401k match
*paid overtime for weekend work, evening work, or early morning work as needed
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.
QUALIFICATIONS
Bachelor's degree preferred, but not required
Experience working neurology studies is a plus, but not required - this site primarily conducts Alzheimer's clinical studies
Phlebotomy experience is required, EKG or other patient labs/processes preferred
Preferably 2+ years of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Clinical Research Coordinator
Clinical Research Coordinator Job 62 miles from North Port
Come grow with us!
We're looking for an entry level Research Coordinator to help us with our expanding research program!
At Sight360, we are building the region's premier destination for comprehensive vision care. We are a team of over 130 optometrists, ophthalmologists, surgeons, opticians, and eye care professionals serving more than 100,000 patients across 15 different locations in the Greater Tampa Bay area. From routine eye exams and optical retail, to medical optometry, ophthalmology, and surgical procedures, our patients experience end-to-end personalized care and service.
Requirements
The Ophthalmic Research Coordinator is responsible for the daily management of clinical caseload to include pre-screening, screening, recruitment, management of maintenance visits, monitoring of adverse events, deviations, completion of all study required procedures as delegated by the Principal Investigator, oversight of monitoring visits, communication with the PI and Operations Manager on subject's status. This position reports to Clinical Research Operation Manager
Essential Functions and Responsibilities:
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Works with the Principal Investigator and Operation Manager to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
Conducts or participates in the informed consent process discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Coordinates participant tests and procedures.
Collects data as required by the protocol. Assures timely completion of Case Report Forms.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or site SOP on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and site SOPs including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Retains all study records in accordance with sponsor requirements and site SOPs.
Maintains effective and ongoing communication with sponsor, research participants, Operations Manager, and PI during the course of the study.
Works with the site staff to manage the day-to-day activities of the study including problem solving, communication and protocol management.
Qualifications:
Clinical Research Certification preferred
Associate's Degree in Health Sciences or similar program preferred
Ophthalmology experience preferred
Skills and Abilities:
Superior interpersonal and communications skills.
Ability to effectively multitask
Attentive to detail and accuracy.
Benefits:
Medical, Dental, Vision
Paid Time Off
8 Paid Holidays
Scrub Reimbursement Program
Employee Recognition Programs
Salary Description $22/hr to $25/hr
Research Nurse - Oncology
Clinical Research Coordinator Job 38 miles from North Port
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:******************************************** 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.
RequirementsEducational Requirements
Degree/Diploma Obtained
Program of Study
Required/
Preferred
and/or
Associate's
Nursing
Required
Bachelor's
Nursing
Preferred
Experience Requirements
Minimum Years Required
Area of Experience
Required/
Preferred
and/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
Licenses
Required/
Preferred
and/or
Registered Nurse License
Required
Certifications/Registration Requirements
Certificates/Registrations
Required/
Preferred
and/or
BLS (American Heart Association / Basic Life Support)
Required
and
ACLS (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
Clinical Research Coordinator
Clinical Research Coordinator Job 227 miles from North Port
Job Title : Clinical Research Coordinator
Department : Site Operations
Reports To : Site Manager
Status : Non-exempt (hourly)
Compensation : $17.00 - $19.00
: We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures.
Essential Duties:
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Provides accurate and timely data collection, documentation, entry, and reporting
Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications :
Bachelor's degree or certified Medical Assistant
If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business.
ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************
Clinical Coordinator
Clinical Research Coordinator Job 38 miles from North Port
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 Coordinator
Clinical Research Coordinator Job 38 miles from North Port
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.