Senior Clinical Research Coordinator - Plant City, Florida
Clinical research associate job in Plant City, FL
Denali Health is seeking an experienced Senior Clinical Research Coordinator to join our dynamic research team. The Senior Clinical Research Coordinator will be responsible for overseeing the planning, coordination, and execution of clinical trials at our research site. The ideal candidate will have substantial experience in clinical research, strong leadership skills, and a deep understanding of regulatory requirements and study protocols.
Key Responsibilities:
Study Coordination & Execution:
Oversee the day-to-day execution of clinical trials, ensuring that protocols, maintaining and improving standard operating procedures (SOPs), and regulatory guidelines are adhered to.
Serve as a point of contact between the study sponsor, PI, and research team.
Coordinate the activities of the clinical research staff to ensure successful and timely completion of study milestones.
Participant Management:
Screen, enroll, and consent study participants in accordance with study protocols.
Ensure study participants' safety and well-being by monitoring adherence to study protocols and identifying and addressing adverse events or protocol deviations.
Data Collection & Documentation:
Collect, record, and manage clinical research data with accuracy and completeness in accordance with Good Clinical Practice (GCP) and sponsor requirements.
Maintain comprehensive and organized records, including study logs, patient files, and study source documents.
Regulatory Compliance & Reporting:
Prepare and submit required regulatory documents, including IRB submissions, FDA forms, and protocol amendments.
Ensure all study documentation is up-to-date, compliant with applicable regulations, and audit-ready.
Collaborate with study monitors, auditors, and other external reviewers to facilitate study reviews and inspections.
Team Leadership & Training:
Mentor and provide guidance to junior research coordinators and support staff, ensuring effective team performance.
Train new staff on study-specific protocols, research regulations, and site SOPs.
Communication & Collaboration:
Liaise with study sponsors, vendors, and internal stakeholders to facilitate effective study management and communication.
Lead study-related meetings, including study initiation, monitoring, and close-out visits.
Qualifications:
Education: Bachelor's degree in health sciences, nursing, or a related field. A Master's degree is p
Minimum of 3 years of clinical research coordination experience. Experience in multiple therapeutic areas or complex clinical trials is an advantage.
Certifications: Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred.
Skills:
Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial best practices.
Strong leadership and project management skills.
Excellent communication and interpersonal skills.
Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
Why Join Denali Health?
We offer a collaborative work environment focused on advancing clinical research and improving patient outcomes. Denali Health provides competitive compensation, career growth opportunities, and a culture dedicated to innovation and excellence.
Apply now if you're ready to make a significant impact in clinical research and take on a leadership role.
Clinic Coordinator - (Mon-Fri 11:30am-8pm)
Clinical research associate job in Auburndale, FL
Clinic Coordinator
Location:450 Brookline Ave, Boston, MA 02215 Category:Administration Support/Customer Service Employment Type:full time
Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer.
Responsibilities:
Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process.
Manage complex scheduling to meet patient needs.
Act as a liaison for patients, families and providers.
Respond to emergent and compliance matters with creative problem solving and critical thinking.
Qualifications
Bachelor's degree preferred.
0 - 1 year experience in a customer service setting.
Proficiency in technology and complex computer systems required.
Ability to work in a fast paced and complex clinical environment.
Professional Growth:
The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry.
Well-Being and Benefits
Health, Dental and Vision Insurance
Time Off
Family & Child Care Benefits and Resources
Retirement Programs
Life Insurance
Short Term Disability
Health Savings Account
Flexible Spending Account
Transportation
LGBTQ+
Our Benefits Partners Include:
Harvard Pilgram Health Care
Delta Dental
Eye Med
Fidelity Investments
Sentinel Benefits Group
Prudential
Voya Financial
TIAA
Care.com
Edukate
Headspace
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Join Our Talent Network
Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.
CLINICAL RESEARCH COORD ASSOCIATE
Clinical research associate job in Tampa, FL
At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.
Summary
Are you looking for an opportunity to impact lives and be a central part of a dynamic and innovative team in the fight against cancer? As a Moffitt Clinical Research Coordinator, you'll bring hope to patients by delivering tomorrow's cancer treatments today! You will have the opportunity to interact directly with patients, enroll, educate and guide them through the experiences of taking part in clinical trials while receiving innovative treatments as part of a therapeutic clinical trial. You will be the member of the Team that ensures the trial is moving forward safely, smoothly, and according to plan.
Our Clinical Research Coordinators come from a variety of backgrounds and experiences, including social sciences (public health, social work, sociology, psychology, communications, and more), biological sciences, business, and humanities. The Clinical Research Coordinator role is a terrific opportunity for those who have already worked in other areas of healthcare as well as those who are looking for a new and exciting way to contribute through their career.
This position offers a Monday through Friday schedule and hybrid work (mix of remote and on-site) after passing a 90-day introductory and training period. Moffitt offers paid training and orientation through its CTO (Clinical Trails Office) Academy. Position tiers may vary according to experience. Relocation assistance may be provided.
*******************************************************************************************
Clinical Trials
These positions work closely with patients, patient families, study sponsors (from smaller pioneer biotech companies through large pharmaceutical companies), and the Clinical Trial Team that includes physicians, pharmacists, nurses, data monitors and data managers.
Successful candidates will possess:
* Effective communication, good decision-making, eagerness to embrace challenges with a sense of urgency and enthusiasm, and time management skills
* Excellent teamwork skills and ability to collaborate with those from diverse backgrounds and experiences
* Prior experience in clinical trials is preferred
* Familiarity with regulatory requirements in clinical research or ability to successfully learn this
* Experience interacting with patients and coordinating care with medical staff
* Gain a solid learning and understanding of regulatory guidelines and following a clinical trial protocol
Position Highlights:
* The Clinical Research Coordinator Associate is a support position that administers duties related to the collection of data and/or the coordination of clinical trials, at Moffitt Cancer Center. Activities support assigned research protocols and include the coordination activities of assigned research protocols (generally non-therapeutic in nature) including obtaining informed consent from study participants, specimen collection and data entry.
* The job is a pre-entry position for the Clinical Trials Coordinator career path or other medical or research career paths.
* Other job duties may include support of therapeutic studies including completion of data entry into various database systems, follow-up of patients according to protocol (via review of records, clinic visit or telephone call), ordering supplies, preparing patient/participant documents for study visits, assisting with the maintenance of regulatory documents, communicating with study sponsors, and facilitating the collection of study-required specimens.
* The position applies job skills and company policies and procedures to complete assigned tasks. Within its administrative support duties, it receives moderate supervision. The assignments are semi-routine in nature, but the CRC Associate recognizes the need for occasional deviation from accepted practice. Requires instructions only on new assignments.
Credentials and Qualifications:
* *Associate's degree
* *In lieu of an associate's degree, 2 years of relevant experience required with a high school diploma or GED
* Bachelor's degree preferred in scientific, health related or business administration program.
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Clinical Research Associate
Clinical research associate job in Tampa, FL
This position collects and manages patient and/or laboratory data for a clinical research project. The position oversees the screening and enrollment of clients, gathers and analyzes data on health care programs, develops databases , analyzes data, ensures quality control, and compiles reports for regulatory compliance.
Nature of Work: This position typically reports to the principal investigator of a clinical research study. The position may perform evaluation duties in preparation for the project. The position then performs project activities such as overseeing the screening and enrollment of potential clients for a health services protocol, developing materials to communicate the project to potential clients and their families, coordinating site visits and appropriate collection of data, ensuring quality control in the data, and compiling regulatory reports. This position may require specific computer expertise and may require maintaining information on a web site. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge, which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Clinical Research Administrators typically oversee temporary staff or Research Support Specialists. They differ from the non-exempt staff by developing techniques and overseeing clinical data gathering, establishing quality control standards, composing educational materials, and acting as liaison with regulatory agencies. Clinical Research Administrators are not overall project directors. They do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports. Work is distinguished from an Administrative and Business Analyst through its primary emphasis on overseeing client recruiting and testing, and analyzing clinical data rather than general administrative work.
This Position is Grant-Funded.
Responsibilities
Oversees medical or health recruiting and screening protocols, collecting data for research studies. May oversee remote screening locations. Monitors laboratory tests and referrals.
Recruits and trains assistants who gather data.
Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented.
Prepares and maintains regulatory and compliance documents such as IRB applications. Interprets rules and regulations pertaining clinical research to ensure compliance in research projects.
Recommends changes in procedures in order to locate, accept, and track clients.
Collects and analyzes data from clinical trials or other medical screening. Creates databases for client information or medical records, and analyzes data.
Collaborates with social workers and professional agencies to provide services related to health conditions.
Composes and disseminates information on studies to clients and the general public.
Acts as performance consultant to subcontractors or health departments to produce model quality programs
Drafts program reports for publication and/or public dissemination.
Provides education to clients and clients' families regarding clinical protocols.
Performs other duties as assigned.
Qualifications
This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.
Auto-ApplySr Clinical Research Associate
Clinical research associate job in Tampa, FL
This position plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives. The position assembles, trains and manages the team assigned to the project. The position documents procedures for the research project and manages reporting and compliance activities, serving as the overall head of project operations.
Nature of Work: This position typically reports to the principal investigator of a clinical research study or to an administrator, such as an Assistant Director who oversees many projects. The position may develop protocols and prepare operations manuals at the initiation of a research study. The position then performs project activities such training and indirectly (or directly) supervising project staff, developing materials to communicate the project to potential clients and their families, making site visits to audit activities, ensuring quality control in the data through resolution of inconsistencies, and compiling regulatory reports. The position acts as the primary resource for explaining the project all parties involved. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Sr. Clinical Research Associates typically oversee staff who are assigned to the project but may not directly supervise. Sr. Clinical Research Associates do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports, but the primary purpose is to oversee and conduct the principal project activities.
This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience.
SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:
(a) Two years of direct experience for an associate degree;
(b) Four years of direct experience for a bachelor's degree;
(c) Six years of direct experience for a master's degree;
(d) Seven years of direct experience for a professional degree; or
(e) Nine years of direct experience for a doctoral degree
Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
PREFERRED:
Bilingual- Spanish. Certified in Clinical Research with a reputable clinical research society. Master's degree in
Biological Science, Public Health, Health Science, Nursing or other directly related field. RN, State of FL.
Phlebotomy trained. Experience in REDCAP, EPIC, eBinder software (FLORENCE) or data
management/Clinical Research tracking software. Prior management experience preferred.
SPECIAL SKILLS/TRAINING:
Ability to work independently and in a group setting. Creative problem solver, ability to manage tight deadline,
impeccable time management, and excellent verbal and written communication
Oversees and designs protocols and electronic case report forms. Develops manual of operations. Reviews medical protocol and prepares draft of document. Coordinates with protocol project manager and study chair preparation of final document for research staff training. Updates the protocols as needed and maintain document version control. Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate. Trains indirect and/or direct reports on policies and procedures, operations, adverse event resolution, protocol creation and review, case report form creation and review, and site data adherence and compliance. Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented. Manages addition of new sites to the network and develops and maintain policies, templates, and related documents for new site additions. Develops and interprets policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP). Collects and analyzes data from clinical trials or other medical screening. Creates data bases based client information or medical records, and analyzes data. Coordinates conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develops related standards, templates and processes. Acts as point of contact and support for consortia research staff.
Auto-ApplyClinical Research Coordinator II
Clinical research associate job in Sarasota, FL
Job Description
Intercoastal Medical Group, Inc is a multispecialty practice serving Manatee and Sarasota counties. Intercoastal is seeking an experienced Clinical Research Coordinator for the Research Department for a full-time weekday shift. For additional information on Intercoastal, please visit ****************************
Intercoastal is a drug free workplace and EEO compliant.
Monday-Friday
8am-5pm
Clinical Research Coordinator II
Clinical research associate job in Brandon, FL
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
* Patient Coordination
* Prioritize activities with specific regard to protocol timelines
* 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.
* Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
* Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
* Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
* Prescreen study candidates
* Obtain informed consent per Care Access Research SOP .
* Complete visit procedures in accordance with protocol.
* Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
* Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
* Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
* Documentation
* Record data legibly and enter in real time on paper or e-source documents
* Accurately record study medication inventory, medication dispensation, and patient compliance.
* Resolve data management queries and correct source data within sponsor provided timelines
* Assist regulatory personnel with completion and filing of regulatory documents.
* Assist in the creation and review of source documents.
* Patient Recruitment
* Assist with planning and creation of appropriate recruitment materials.
* Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
* Actively work with recruitment team in calling and recruiting subjects
* Additional Duties
* Review and assess protocol (including amendments) for clarity, logistical feasibility
* Ensure that all training and study requirements are met prior to trial conduct.
* Communicate clearly verbally and in writing.
* Attend Investigator meetings as required.
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
The Expertise Required
* Ability to understand and follow institutional SOPs.
* Excellent working knowledge of medical and research terminology
* Excellent working knowledge of federal regulations, good clinical practices (GCP)
* Ability to communicate and work effectively with a diverse team of professionals.
* Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
* Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
* Critical thinker and problem solver
* Friendly, outgoing personality; maintain a positive attitude under pressure.
* High level of self-motivation and energy
* Excellent professional writing and communication skills
* Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
* Bachelor's Degree preferred, or equivalent combination of education, training and experience.
* A minimum of 3 years prior Clinical Research Coordinator experience required
* Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
* Recent phlebotomy experience required
How We Work Together
* Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Brandon, FL clinic.
* Travel: Regularly planned travel within the region will be required as part of the role.
* Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members.
Benefits & Perks
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Research Coordinator
Clinical research associate job in Tampa, FL
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Essential Responsibilities and Duties:
Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
Organizes research information for clinical trials.
Observes subjects and assists with data analysis and reporting.
Schedules the collection of data.
Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
Monitors, and reports research data to maintain quality and compliance.
Performs administrative and regulatory duties related to the study as appropriate.
Participates in other protocol development activities.
Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
Educates potential participants and caregivers on protocol specific details and expectations.
Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
Assists the CTM in planning, creating processes, trainings and development of staff.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position.
High school graduate or equivalent; Bachelors Degree, preferred
CCRC certification preferred
2-3 years of experience in the medical field, preferred
Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
Strong leadership and mentorship skills.
Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
Works independently as well as functioning as part of a team.
Must be able to effectively communicate verbally and in writing.
Working Conditions
Indoor, Office environment.
Shift work, depending on location.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Overnight travel may be required for training and/or investigative meetings.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Clinical Research Coordinator (FWSCC)
Clinical research associate job in Tampa, FL
Job Details Florida West Coast Skin and Cancer Center (FWC) - Tampa, FLDescription
We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of clinical research coordinator. Clinical research coordinators are responsible for conducting clinical research trials by adhering to Good Clinical Practice (GCP), International Air Transportation (IATA) and FDA regulations. The candidate will be performing required visit procedures, administering questionnaires and subject material, adhering to regulatory trial standards, and participating in subject recruitment efforts, among other duties.
Clinical research coordinators need to engage with the research investigators, pharmaceutical companies (sponsors) and contract research organizations (CROs) as well as the research subjects requiring excellent interpersonal and communicative skills.
Clinical Research Coordinator Responsibilities:
Overseeing the smooth running of clinical trials.
Performing clinic visits as per the protocol, GCP and FDA
Completing procedures such as phlebotomy, EKGs Vitals, assessments
Collecting and entering data obtained for the trial
Informing participants about study objectives.
Administering questionnaires.
Monitoring research participants to ensure adherence to study rules.
Adhering to research regulatory standards.
Adhering to ethical standards.
Maintaining detailed records of studies as per FDA guideline and regulatory documentation
Managing investigational medication including receiving, dispensing, storing and performing accountability
Liaising with laboratories process, ship and ensure investigators review reports
Participating in subject recruitment efforts.
Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
Engaging with subjects and understanding their concerns and managing the visit flow as indicating in the protocol.
Qualifications
Qualifications:
Attention to detail.
Exceptional interpersonal skills.
Good computer and technical skills
Outstanding written and verbal communication.
Excellent organizational skills.
Willingness to continually self-educate.
CCRC certification a plus
Bi-lingual in Spanish is a plus
Clinical Research Assistant - Brandon
Clinical research associate job in Brandon, FL
Job Description
The Clinical Research Assistant will assist the Clinical Research Coordinators (CRC) in the conduct of industry-sponsored clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. To support study conduct, the candidate should have experience in research, clinical trials, or a related field. The individual should be familiar with the processes involved in conducting research studies and should have experience in the collection and management of data. The RA is immediately accountable to the CRC and works with them and other study team members to meet study-specific goals and timelines and communicate appropriately and effectively with subjects, investigators, CRC's, and other staff. Organizational skills are critical in this role. The candidate should be able to manage multiple tasks, keep detailed records, and maintain an orderly work environment. Attention to detail is also essential, as the individual will be responsible for ensuring accuracy in all aspects of the study. Professionalism is another critical attribute. The individual should have excellent communication skills, be able to work collaboratively with others, and maintain a high level of confidentiality
Clinical and Administrative
Ability to perform clinical tasks including assisting the Principal Investigator, Sub-Investigators and study coordinators with study procedures and other study requirements as needed
Ability to work as a team and independently. Under the direction of the CRC, Investigator, Supervisor and Clinical Operations Manager
Perform study activities according to the protocol and standard operation procedures, follow instructions, perform other duties as needed
Good communication and time management skills
Flexible and self-motivated
Ability to follow responsibilities to completion
Basic computer skills
May be added as a back-up study coordinator to help conduct studies.
Assist with enrollment of new patients
Follow Up with phone calls
Pre-Screen & Screen patients
Conduct Informed Consent process
Must be ok with venipuncture and blood draw
Must be able to perform data entry
This individual will work with study registries and must be organized and comfortable with typing and performing data entry
Must be ok with the shipping and handling of study specimens
Professional
Demonstrates initiative and responsibility
Able to perform repetitive tasks without loss of focus
Adheres to ethical principles
This is the compensation range for this position.
Compensation Range$45,000-$53,000 USD
Clinical Research Coordinator
Clinical research associate job in Lakeland, 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 Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Key Responsibilities
Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
* Screening of patients for study enrollment;
* Patient consents;
* Patient follow-up visits;
* Documenting in source clinic charts;
* Entering data in EDC and answers queries;
* Obtaining vital signs and ECGs;
* May 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;
* Requesting and tracking medical record requests;
* Updating and maintaining logs, chart filings;
* Maintaining & ordering study specific supplies;]
* Scheduling subjects for study visits and conducts appointment reminders;
* Building/updating source as needed;
* Conducting monitoring visits and resolves issues as needed in a timely manner;
* Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
* Filing SAE/Deviation reports to Sponsor and IRB as needed;
* Documenting and reporting adverse events;
* Reporting non-compliance to appropriate staff in timely manner;
* Maintaining positive and effective communication with clients and team members;
* Always practicing ALCOAC principles with all documentation;
* May assist with study recruitment, patient enrollment, and tracking as needed;
* Maintaining confidentiality of patients, customers and company information, and;
* Performing all other duties as requested or assigned.
* Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
* Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
* May set up, train and maintain all technology needed for studies.
Skills, Knowledge and Expertise
Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly 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);
* Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
* 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.
Clinical Research Coordinator
Clinical research associate job in Clearwater, FL
Job DescriptionBenefits:
Competitive salary
Dental insurance
Health insurance
Paid time off
Vision insurance
The Clinical Research Coordinator will work under the direction of the Principal Investigator to manage and execute clinical trials in accordance with Good Clinical Practice, FDA regulations, and study protocols. This position requires a detail-oriented professional with strong communication skills to ensure the safety of trial participants and the integrity of study data.
Key Responsibilities:
Oversee the day-to-day operations of assigned clinical trials from start-up to close-out. Ensure strict adherence to study protocols and all regulatory requirements, including those from the FDA and IRB. Accurately collect, record, and maintain source documents, case report forms, study data and assist with query resolution. Act as a liaison between the Principal Investigator, study participants, sponsors, and monitors. Maintain accurate accountability records and manage the inventory of study supplies and investigational products. Participate in monitoring visits, audits, and inspections.
Must have a strong knowledge of GCP, HIPAA, and FDA regulations, excellent communication skills, strong attention to detail, exceptional written and verbal communication and interpersonal skills and the ability to work independently and manage multiple priorities.
Full-time position with PTO, health insurance, dental insurance, vision insurance and holiday pay.
CCRC certification preferred.
Clinical Research Coordinator
Clinical research associate job in Largo, FL
Job Title: Clinical Research Coordinator Contract Duration: 6 Months Hours: 7am-4pm Job Summary: The Research Coordinator is responsible for coordinating multiple research protocols and serving as aliaison with local investigators and sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations to achieve a fundamental understanding of human subject research.
Key Responsibilities:
* Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement."
* Complete assigned training requirements by the due date.
* Perform routine operational activities for multiple research protocols.
* Liaise between site research personnel, industry sponsors, and supervisor.
* Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable.
* Coordinate schedule of assessments from initial submission of feasibility until study closeout.
* Review the study design and inclusion/exclusion criteria with physician and patient.
* Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements.
* Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitor data for missing or implausible data.
* Create study-specific tools for source documentation when not provided by sponsor.
* Collect, complete, and enter data into study-specific case report forms or electronic data capture systems.
* Generate and track drug shipments, device shipments, and supplies as needed.
* Ensure timely and accurate data completion.
* Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
* Communicate all protocol-related issues to appropriate study personnel or manager.
* Attend study-specific on-site meetings, investigator meetings, conference calls, and monthly CRC meetings, as required.
* Review and respond to any monitoring and auditing findings.
Qualifications:
* 1+ years of relevant experience.
* Bachelor's Degree required.
* Occasional travel: The job may require travel from time to time, but not on a regular basis.
Skills:
* Strong organizational and time management skills.
* Excellent communication and interpersonal skills.
* Ability to work collaboratively with various departments and teams.
* Attention to detail and accuracy in data collection and reporting.
* Familiarity with research protocols and regulatory requirements.
Pay and Benefits
The pay range for this position is $30.00 - $32.00/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 Largo,FL.
Application Deadline
This position is anticipated to close on May 9, 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.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
CLINICAL RESEARCH ASSISTANT I
Clinical research associate job in Sarasota, FL
Job Description
The Clinical Trials Department is seeking a full-time Clinical Research Assistant to support a variety of human subject research studies. This position provides a unique opportunity to work alongside experienced investigators, research coordinators, and clinicians engaged in clinical trials targeting memory disorders, neurodegenerative diseases, brain injury, and environmentally linked health conditions.
This is an excellent opportunity for recent graduates or early-career professionals interested in neuroscience, psychology, public health or clinical research. Training will be provided, and there is strong potential for professional growth and advancement within the Institute's research programs.
Key Responsibilities
Responsibilities include, but are not limited to:
Becoming familiar with, and staying current on, lifestyle guidance recommended through our Healthy Aging program
Reviewing relevant literature and clinical trial protocols, and maintaining regulatory compliance
Preparing and completing source documentation to record subject data
Entering subject visit data into sponsor-specific electronic data capture (EDC) systems
Maintaining accurate records and tracking clinical supplies
Supporting participant visit tracking and internal database documentation
Identifying potential study participants via EMR chart reviews or community presentations
Conducting telephone pre-screening, explaining study protocols, and determining initial eligibility
Scheduling study visits and providing appointment reminders
Responding to memory screening requests from the public and managing intake
Entering and managing data in-house for internal Roskamp research projects
Preferred Skills & Attributes
Strong interpersonal and professional communication skills
Organized, detail-oriented, and accountable work style
Ability to quickly learn multiple data entry and scheduling systems
Familiarity with medical terminology and clinical workflows
Comfortable working in a team environment and supporting multiple coordinators
Experience in cognitive training/cognitive health preferred
Able to multitask, prioritize, and remain calm under pressure
Qualifications
Bachelor's degree in health sciences, psychology, neuroscience, public health, or a related field preferred
Experience in clinical research, healthcare, or data management is advantageous
Knowledge of HIPAA and GCP (Good Clinical Practice) principles is a plus
Candidates with a strong interest in human subject's research and translational neuroscience are encouraged to apply
About the Clinical Trials Program
The Roskamp Institute's Clinical Trials Division conducts both industry-sponsored and investigator-initiated studies. Current areas of research include:
Healthy Aging
Alzheimer's disease and mild cognitive impairment (MCI)
Traumatic brain injury (TBI)
Gulf War Illness
Neurological and systemic effects of environmental exposures
Ongoing studies include development of a community-based brain health program focused on reducing risk for Alzheimer's Disease.
Compensation & Benefits
Competitive salary based on experience
Paid time off (PTO), paid holidays, and sick leave
Health, dental, and vision insurance
403(b) retirement savings plan with employer contribution
Opportunities for continuing education and professional development
Exposure to cutting-edge translational research and clinical trials
Supportive and mission-driven work culture
Radiologic Technology Clinical Coordinator - Adjunct
Clinical research associate job in Clearwater, FL
Job Description
The Clinical Coordinator position plans, coordinates, facilitates, administers, and monitors, activities on behalf of the academic program and in coordination with academic and clinical faculty. These activities ensure the quality of our students learning experience during clinical education. Clinical Coordinators accomplish this through:
Assists with the development and assessment of the clinical education component of the curriculum with the Program Director.
Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation.
Responsible for facilitating students' clinical education.
Responsible for ensuring clinical education program compliance.
EDUCATION, EXPERIENCE AND TRAINING:
Minimum of a bachelor's degree
At least 2 years of clinical practice experience in the professional discipline
Proficient in curriculum development, supervision, instruction, evaluation, and academic advising
Documents one year's experience as an instruction in a JRCERT accredited program
Current, American Registry of Radiologic Technologists (ARRT) certification and registration, or equivalent, in radiography
Clinical Res Coordinator II
Clinical research associate job in Bradenton, FL
Job Description
Job Summary: The Clinical Research Coordinator II's primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study. Due to enhanced experience at FRI the CRC II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to community, sponsors, CRO's and study participants and family members.
Our Culture: Inspire hope. Build your legacy. Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialist, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.
Duties include but are not limited to:
Study Preparation:
Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff
Assist with planning and creation of appropriate recruitment materials
Assist in development of recruitment plan and obtain listing of potential candidates to contact from database
Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
Participate in Investigator's meeting and /or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives
Create (or review sponsor provided) protocol specific source documents
Determine facility, equipment and outsource vendor availability
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Ensure education of staff and/or sub-investigators is completed for required tasks
Study Management:
Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines
Maintain organized files for blank source documents, patient charts, CRFs and supplies
EDC entry of required visits within 72 hours of visit elements being completed
Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records
Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings
Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of FRI team in an ongoing fashion
Develop and maintain effective relationships with study participants and FRI personnel
Complete End of Study Packets for Patient Liaisons
Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnel
Communicate clearly verbally and in writing
Accept accountability for actions and function independently
Patient Coordination:
Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
Contact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changed
Obtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation required
Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manual
Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
Review laboratory results, ECGs, and other test results (e.g., biopsy results) for completeness and alert values, ensure investigator review in a timely fashion
Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaround
Dispense study medication per protocol and or IVRS system. Educate patient on proper administration and importance of compliance
Monitor patient progress on study medication
Documentation:
Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
Accurately record study medication inventory, medication, dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashion
Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
Record protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients' charts and regulatory filing if necessary
Ensure all sponsor correspondence (emails, telephone conversations) are printed and given to appropriate personnel for regulatory filing
Maintain copies of patient-specific correspondence in source charts
Assist regulatory personnel with completion of continuing/final review reports
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all- inclusive.
Knowledge, Skills, and Abilities:
Good working knowledge of medical and research terminology
Enhanced working knowledge of federal regulations, good clinical practices (GCP)
Ability to mentor and guide less experienced CRCs as they develop and gain experience
Ability to communicate and work effectively with a diverse team of professionals
Excellent organizational, prioritization and leadership skills and capabilities
Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel
Excellent interpersonal skills, detailed-oriented and meticulous
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision
Experience:
Two years clinical research experience
Two years Clinical Research Coordinator experience
A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form
License/Certification:
RN or LPN preferred
Research Professional Certificate- CCRC or exam eligibility preferred
When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!
Clinical Research Coordinator II
Clinical research associate job in Tampa, FL
The primary purpose of this position is to be the main point of contact for sponsors and patients for specific research protocols. This position is responsible for performing the screening, enrollment, and retention of study participants, ensuring quality of data collected throughout the research study, and implementing the procedures and activities under the direction and oversight of the lead coordinators and principal investigators of the projects.
Minimum Education & Experience
• Bachelor's degree in a related field -OR- equivalent combination of education and experience.
• Minimum of two (2) years of related experience.
• Senate Bill 1310- The Florida Senate (************************************************ is
conditional upon meeting all employment eligibility requirements in the U.S.
• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
• A public employer may include a postsecondary degree as a baseline requirement only as an
alternative to the number of years of direct experience required, not to exceed:
• (a) Two years of direct experience for an associate degree;
• (b) Four years of direct experience for a bachelor's degree;
• (c) Six years of direct experience for a master's degree;
• (d) Seven years of direct experience for a professional degree; or
• (e) Nine years of direct experience for a doctoral degree
• Related work experience may not substitute for any required licensure, certification, or registration
required for the position of employment as established by the public employer and indicated in the
advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.
Knowledge, Skills & Abilities
• Comprehension of clinical research principles, Good Clinical Practice Guidelines, and regulatory
requirements.
• Attention to detail, critical thinking, ability to follow protocols,
• Ability to maintain quality standards, planning and scheduling, data collection, clear
communication, and organization.
• Ability to communicate and interact competently and professionally at all levels within a broad,
complex clinical research environment.
• Ability to provide technical advice, guidance, and support to professional and support staff
• Skill in the use of personal computers and related software applications.
Working Conditions
• Environment - Typical indoor environment/office setting.
• Physical Requirements - climbing, standing, stooping, and/or typing; Ability to lift up to 20lbs as
needed.
• Travel - Ability to travel to other USF campuses and/or other locations as requested.
Primary Job Duties
• Plans, organizes, and manages the resources necessary to achieve clinical research project
goals and objectives at a single site.
• Coordinates and performs patient clinical assessments for clinical trial visits for assigned clinical trial protocols including scheduling with vendors which may include other departments or outside facilities. This may include phlebotomy, sample processing, vitals, ECGs and other delegated clinical assessments per assigned protocols.
• Communicates as a site representative with study sponsors, third party vendors, clinical teams and patients to ensure all protocol required elements are being completed and collected within the defined windows.
• Ensures site compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends site monitoring meetings with sponsors.
• Manages the site research project databases, develops flowsheets and other study related documents, and completes source documents/case report forms.
• May provide guidance to other clinical research staff and support personnel.
• Makes recommendations of procedures in order to facilitate protocol compliance.
• Performs data entry and query resolution during the duration of each trial assigned.
• Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes at the site.
• Performs other duties as assigned.
Auto-ApplyClinical Research Assistant
Clinical research associate job in Saint Petersburg, FL
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization.
How You'll Make An Impact
* Ability to understand and follow institutional SOPs
* Participate in recruitment and pre-screening events (may be at another location)
* Assist with preparation of outreach materials
* Identify potential participants by reviewing medical records, study charts and subject database
* Assist with recruitment of new participants by conducting phone screenings
* Request medical records of potential and current research participants
* Schedule visits with participants, contact with reminders
* Obtain informed consent per Care Access Research SOP, under the direction of the CRC
* Complete visit procedures as required by protocol, under the direction of the CRC
* Collect, process and ship specimens as directed by protocol, under the direction of the CRC
* 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
* 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.
* Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.
* Communicate clearly verbally and in writing.
* Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
* 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
* An optimistic, "can do" attitude
Certifications/Licenses, Education, and Experience
* A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist.
* Phlebotomy Experience and Proficiency Required
* Some Clinical Research experience preferred
* California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
* Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
* Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
* Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
* Location: This is an on-site position with regional commute requirements, located in St. Petersburg, FL
* Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
* Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $19.00 - $38.00 USD per hour for full time team members.
Benefits & Perks (Full Time Employees)
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Clinical Research Assistant - Ataxia
Clinical research associate job in Tampa, FL
This position typically reports to the Principal Investigator, Clinical Research Manager, or Clinical Research Coordinator. This job is a pre-entry position for the Clinical Research Coordinator career path. Within its specialized support duties, it receives moderate supervision. Handles basic issues and problems and refers more complex issues to higher-level staff. The assignments are semi-routine in nature, including collecting and entering data and working with the study coordinator to ensure their accuracy and integrity, in strict adherence to study protocols. Requires knowledge and experience with basic computer skills and web-based applications.
This is a Grant-Funded Position. This position is NOT eligible for Visa Sponsorship.
Responsibilities
• Assists with the evaluation of potential research participants with the study team and Principal Investigator.
• Assists with screening, enrollment, and retainment of study participants at the site.
• Schedules participant site visits and maintains records.
• Assists Clinical Research Coordinators and site study team in recording data on each study participant for each visit according to research protocol.
• Assists with the implementation of procedures and activities of assigned study protocols.
• Participates in coordinating, preparing, and conducting site monitoring visits, audits, and inspections.
• Collects vitals and assists study coordinator with patient visits at the site.
• Collects study specimens according to the protocol which may include phlebotomy, processing, and preparation for shipping.
• Performs data entry for clinical trials.
• Assists with site quality assurance and tracks regulatory submissions.
• Performs other duties as assigned.
Qualifications
• High School Diploma or equivalent required.
• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
Degree Equivalency Clause: Four years of direct experience for a bachelor's degree.
• Senate Bill 1310- The Florida Senate (************************************************ is conditional upon meeting all employment eligibility requirements in the U.S.
• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
• A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:
• (a) Two years of direct experience for an associate degree;
• (b) Four years of direct experience for a bachelor's degree;
• (c) Six years of direct experience for a master's degree;
• (d) Seven years of direct experience for a professional degree; or
• (e) Nine years of direct experience for a doctoral degree
• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Lakeland, FL
Department
Operations
Employment Type
Full Time
Location
Accel Research Sites - Lakeland, FL
Workplace type
Onsite
Reporting To
Colleen Figueroa
Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.