Weights and Research Coordinator
Clinical research coordinator job in Louisville, KY
Full-Time Monday-Friday, Various shifts
Come and experience the difference with R+L Carriers
Earn 1 week of vacation after 90 days of employment
salary range: $60,000.00-$65,000.00
Requirements:
Any type of LTL experience preferred but not required
Ability to self-motivate and self-manage
Willingness to learn
Analytical skills
Computer proficiency
Able to work in a fast-paced environment
Excellent Benefits
R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC.
Click here ****************************
Auto-ApplyClinical Research Associate
Clinical research coordinator job in Lexington, KY
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a Clinical Research Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Auto-ApplyClinical Research Associate II
Clinical research coordinator job in Louisville, KY
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Coordinator II
Clinical research coordinator job in Memphis, TN
Job Description
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
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
Licenses:
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: Memphis, TN
This is a part-time temporary role lasting for 6 months
Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Type of travel required: Regional (within 100 miles)
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Walking - 20%
Standing - 20%
Sitting - 20%
Lifting - 20%
Up to 25lbs
Over 25lbs
Overhead
Driving - 20%
The expected salary range for this role is $60,000 - $90,000 USD per year 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 Coordinator - Full-Time - Wolf River
Clinical research coordinator job in Germantown, TN
Job Title: Clinical Research Coordinator
About Us
At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients' lives. Join us in our mission to provide comprehensive support to those navigating the challenges of cancer treatment.
Position Overview
The Clinical Research Coordinator plays a vital role in managing oncology patients participating in pharmaceutical-sponsored clinical trials. This position is responsible for patient screening, enrollment, education, and ongoing monitoring to ensure compliance with study protocols and regulatory standards. The ideal candidate will have prior experience managing clinical trials and a strong understanding of Good Clinical Practice (GCP) and FDA regulations.
Key Responsibilities
Recruit and screen potential clinical trial subjects
Conduct detailed review of patient medical history and current findings for eligibility
Educate nursing staff on proper administration and side effects of study therapies
Educate patients on study protocols, medication adherence, and symptom management
Act as a liaison between the Research Team and non-research clinical staff
Maintain patient safety, rights, and informed consent throughout the study
Ensure regulatory compliance and maintain current knowledge of the Code of Federal Regulations
Monitor study progress and patient outcomes
Interface with multiple departments, including Physicians, Nurses, Radiology, Medical Records, Laboratory, Insurance, and Pharmacy
Document all relevant patient and study information accurately
Maintain a professional demeanor and uphold confidentiality at all times
Perform other duties as assigned
Qualifications
Education & Experience
Associate's degree or equivalent from a two-year college or technical school
Minimum of 1-2 years of related clinical research experience, or successful completion of 1 year as an Associate Clinical Research Coordinator I
Preferred: Registered Nurse (RN) certification
Skills & Abilities
Strong organizational, follow-up, and problem-solving skills
Excellent verbal and written communication abilities
Ability to manage multiple priorities in a fast-paced environment
Proficiency in computer applications, including word processing and email
Ability to collaborate effectively within multidisciplinary teams
Strong knowledge of clinical research regulations, data management, and patient safety
Comfort working near potentially hazardous materials
Ability to analyze complex data and interpret technical documents
Competence in performing necessary calculations (BSA, ANC, drug dosing)
Ability to travel as required
Why West Cancer Center is a Great Place to Work
Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.
Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.
No nights, weekends, or holidays. Comprehensive benefits package.
Join Us
If you are a detail-oriented clinical research professional looking to make a difference in oncology care, apply today to become a Clinical Research Coordinator at West Cancer Center.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Lebanon, TN
Job DescriptionAbout Hawthorne Health:Hawthorne Health is dedicated to advancing clinical research and improving patient outcomes through high-quality, community-based clinical trials. We partner with leading sponsors and investigators to bring innovative therapies to our patients in a compassionate, professional setting.
Position Overview:Hawthorne Health is seeking an experienced Clinical Research Coordinator (CRC) to join our Lebanon, TN site. The ideal candidate will be detail-oriented, highly organized, and experienced in all aspects of clinical trial coordination. This individual will work closely with investigators, patients, and sponsor representatives to ensure successful execution of clinical trials in compliance with all regulatory and protocol requirements.Key Responsibilities
Conduct and coordinate all aspects of clinical trial activities at the site.
Perform phlebotomy on both pediatric and adult patients, following proper clinical and safety protocols.
Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
Schedule and conduct study visits, ensuring adherence to protocol requirements.
Accurately collect, process, and ship biological samples per study-specific guidelines.
Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
Perform timely and accurate data entry into electronic data capture systems (EDC).
Communicate effectively with sponsors, monitors, and other research team members.
Ensure compliance with GCP, ICH, FDA, and IRB regulations.
Assist in monitoring visits and audit preparation as needed.
Qualifications
Minimum of 1-2 years of experience as a Clinical Research Coordinator role.
Phlebotomy certification or demonstrated competency in venipuncture (pediatric and adult required).
Strong understanding of clinical trial operations, regulatory documentation, and data management.
Excellent attention to detail, organization, and time management skills.
Strong interpersonal and communication abilities with patients and clinical staff.
Proficient in Microsoft Office and electronic data capture systems.
CPR certification preferred.
Location
This is a part-time contract position requiring on-site presence in Lebanon, TN two (2) days per week.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Clinical Research Coordinator / Project Managers
Clinical research coordinator job in Nashville, TN
Job Description
At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.
K2 is building a talent pipeline for future Clinical Research Coordinator / Project Managers for our Nashville, TN clinic. The Clinical Research Coordinator will manage clinical trial performance and ensures conduct is congruent to the philosophy and mission of K2 Medical Research. Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.
This is an evergreen requisition, meaning we don't have an immediate opening, but we're actively seeking talented professionals for upcoming opportunities. By applying, your information will be reviewed and considered for future roles as they become available. If you're interested in a future with K2 Medical Research, we encourage you to apply!
Primary Responsibilities:
Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator
Articulate all pertinent issues to the Pl or document by email/letter or during meetings
Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research
Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
Maintain timely K2 Medical Research source documentation as well as sponsor required information.
Dispense and maintain accurate records of study medication
Educate patients and family regarding their particular study and clinical drug trials in general.
Complete all monitor and sponsor queries in a timely manner
Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study
Knowledge, Skills, and Abilities:
Outstanding verbal and written communication skills
Excellent interpersonal and customer services skills
Strong time management and organizational skills In depth knowledge of industry regulations
Proven ability to and foster mentoring relationships
Ability to create momentum and foster organizational change
Qualifications:
HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
Two years of experience in a clinical environment. Experience in clinical research is ideal.
Experience in phlebotomy required.
LPN, RN, or other medical licensure or certification preferred.
Strong working knowledge of GCP and FDA guidelines
Knowledge of medical terminology
BLS Healthcare Provider required
Applicants that do not meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval.
Benefits:
We value our employees and their professional and personal needs, and support these through our benefit offerings:
Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.
Join the K2 Family: Where Compassion and Connection Lead the Way!
At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.
We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at HR@k2med.com, and we'll ensure you have everything you need to shine.
Clinical/Translational Research Coordinator II
Clinical research coordinator job in Nashville, TN
Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Organization:
VMAC
Job Summary:
The Vanderbilt Memory and Alzheimer's Center seeks a qualified applicant for a Clinical & Translational Research Coordinator II position. The coordinator will be part of a large, longitudinal National Institutes of Health-funded study. This study focuses on understanding risk factors for Alzheimer's disease and cognitive decline in aging adults. Specific coordinator responsibilities are described below.
The work for this position will be performed on site at VUMC's Crystal Terrace office located at 3319 West End Ave. in Nashville, TN and will work Monday-Friday, traditional, day-time business hours. Flexibility is key to being successful in this role.
.
DEPARTMENT SUMMARY:
At the Vanderbilt Memory and Alzheimer's Center, we are at the forefront of advancing knowledge in Alzheimer's disease prevention, early diagnosis, and treatment. Through our research, we aim to pave the way for a new era of understanding and managing Alzheimer's disease and related dementias. For more information, please visit*******************************
Responsibilities
Protocol Implementation & Coordination
Approximately half of the position is participant-facing and focused on protocol implementation and coordination of study visit activities, such as:
- Screening participants and assessing study eligibility
- Administering and scoring cognitive protocols
- Collecting medical history information from participants and their loved ones
- Accompanying participants to visit procedures, such as blood work, brain MRI, and cardiac imaging appointments
- Collecting participant and study partner questionnaire data and reviewing documents for accuracy and completeness
- Coordinating preparation and distribution of ambulatory blood pressure and actigraphy monitors
Data Management & Administrative Activities
Approximately half of the position is focused on administrative and data management activities to support participant visits, such as:
- Completing medical record requests and managing medical record data
- Coding, entering, and managing participant data
- Maintaining participant charts, including source documents, medical release forms, and consent documents
- Completing disbursement/reimbursement paperwork for participant payments
- Contributing to participant retention activities
The position provides an excellent opportunity to work within a large interdisciplinary team and develop and refine clinical research skills, especially for applicants interested in building a career in clinical research.
Position Requirements
A bachelor's degree and a minimum of 1 year of professional experience is required. Prior research experience is preferred. Candidates should be proficient in all Microsoft applications with excellent organizational skills, exceptional attention to detail, and the ability to multi-task in a fast-paced environment. Candidates should also be able to master tasks quickly and independently and work well as part of an interdisciplinary team.
GENERAL KEY RESPONSIBILITIES for CLINICAL/TRANSLATIONAL RESEARCH COORDINATOR II:
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial
Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.
Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.
Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.
World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.
Aligning with Vanderbilt Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.
Core Accountabilities:
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.
Core Capabilities :
Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.
Position Qualifications:
Responsibilities:
Certifications :
Work Experience :
Relevant Work Experience
Experience Level :
1 year
Education :
Bachelor's
Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Nashville, TN
The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study.
To consistently embody AMR Clinical's Core Values:
United We Achieve
Celebrate Diverse Perspectives
Do the Right Thing
Adapt and Persevere
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
Establish understanding of SOP's and implement the SOP's
Gain understanding of the pharmaceutical drug per clinical trial.
Develop detailed knowledge of protocol and procedures per clinical research study.
Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry.
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.
Establish and maintain patient rapport.
Clinical data collection (vital signs, EKG recording, weight, height, etc.)
Obtain medical records and review as required.
Phlebotomy
Specimen collection, processing, and storage
Transporting clinical specimens to the laboratory.
Educate subjects on diaries and oversees compliance with diary completion.
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
Responsible for completing patient phone call visits in accordance to the standard protocol period.
Ensure documentation follows ALCOA standards and is completed in a timely manner.
Ensure all necessary documents are completed, signed and dated.
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
Manage study inventory and order supplies as needed.
Prepare and assist study monitors during onsite visits.
Maintain familiarity with all ongoing clinical research studies.
Travel to Investigator meetings as needed.
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
Position may require occasional weekend and/or overtime hours.
Other duties as assigned
Desired Skills and Qualifications:
1 year of experience in clinical research.
Completion of formal medical training, educational program, or healthcare experience
Strong medical terminology
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
Ability to work independently and lead study-related tasks.
Ability to multi-task in a high-paced evolving environment.
Exceptional listening, written, and verbal communication skills as well.
Demonstrate proficiency in office equipment and software programs.
Excellent organizational and task management skills.
Ability to be ambulatory most of the workday.
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Tennessee
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Reports To: Manager, Clinical Research
Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards.
FLSA: Non-Exempt
Supervisory Responsibility: This position has no supervisory responsibilities
Key Responsibilities
Administratively and clinically manage industry sponsored clinical trials.
Adhere to Research SOP's, Good Clinical Practices, and the study protocols.
Assist in patient recruitment by performing detailed chart reviews and patient interviews.
Discuss study protocols with patients and verify the informed consent documentation.
Review medical history of patient against inclusion/exclusion criteria of studies.
Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
Schedule all patient research visits and procedures consistent with protocol requirements.
Dispense study medication, collect vital signs, and perform ECGs.
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy.
Function in a clinical role by conducting clinical research studies.
Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients.
Maintain compliance of protocols and regulatory guidelines for studies performed in the research area.
Act as a resource for other staff members regarding investigational issues or guidelines.
Coordinate the availability and distribution of medications for patients in a timely manner.
Perform phlebotomy for lab work as required and completes all necessary forms.
Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures.
Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.
Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
Plan, implement, and maintain data collection and analysis systems in support of the research protocol.
Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
Facilitate assigned clinical trial from start to finish.
Screen participants for all studies independently.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required.
Adhere to infection control/safety guidelines and confidentiality policies.
Core Competencies
Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated
General
Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
Incorporate a leadership mindset to your role.
Comply with One GI procedures, policies, and regulations relevant to your role.
Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.)
Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws.
Computer skills - good working knowledge of MS office.
Ability to communicate effectively with others, both verbally and in writing.
Proven ability to manage time, meet deadlines and prioritize.
Able to maintain standards and professionalism during periods of fluctuating workloads.
Provide professional service to direct customers of One GI in all interactions.
Build effective working relationships with other team members.
Manage daily tasks to ensure business needs are consistently met.
Education and Qualifications
High School Diploma or equivalent required.
Associates degree in a clinical or scientific related discipline required.
Bachelor's degree preferred.
One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required.
Previous GI trials experience preferred.
Clinical experience in an office or hospital setting.
Research experience or equivalent.
Must maintain current licensure and/or certification.
Basic Life Support certification required.
Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
Familiarity with health care systems, regulations, policies, and functions.
Understanding of clinical research documentation standards.
Knowledge of equipment, supplies, and materials needed for medical treatment.
Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails.
Registered Nurse with five (5) years experience required.
BSN preferable.
Membership in local, state and national societies is encouraged.
Understanding of Code of Federal Regulations for Human Subjects.
Certified in GCP's and HSP.
Periodic local travel to other practice locations on an as-needed basis.
Phlebotomy experience preferred.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly requiredto speak and hear. Understand/comprehend English as well as read/follow written English instructions.
This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching.
It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening.
Work Environment
This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above 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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at anytime with or without notice.
Accommodations
Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with theneeds of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplyClinical Research Coordinator I
Clinical research coordinator job in Lexington, KY
Baptist Health is looking for a Clinical Research Coordinator I to join their team in Lexington.
Under limited supervision, the Clinical Research Coordinator I (CRC) coordinates patient care in compliance with local, state and federal guidelines and regulations through IRB approved protocol requirements. The CRC uses their developing and/or basic knowledge of clinical trial research along with their hospital experience to work collaboratively with individuals associated with the care and treatment of the patient. It is the expectation the CRC will utilize day-to-day experience and collaborations with senior staff to broaden their knowledge base and capabilities. They will seek out opportunities to build their knowledge of the organization, research processes and scope of work. They will understand the guidelines, regulations, and policies associated with conducting clinical trial research and use that insight to evaluate and resolve problems or seek out guidance. The CRC collaborates with the investigators, research staff and other departmental stakeholders to conduct clinical trial coordination per protocol. Through clear documentation, the CRC will define any changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention. The CRC works collaboratively with individuals associated with the care and treatment of the patient.
Qualifications:
Technical Diploma or Degree/certification must be in biology, public health, pharmacy, or health related field.
3 years' experience.
Previous experience in oncology clinical research or as a clinical trial coordinator.
Proficient with a computer including navigating websites, electronic data systems, electronic medical records, Excel, Word, PowerPoint.
Work Experience
Relevant Work Experience
Education
If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!
Baptist Health is an
Equal Employment Opportunity
employer.
Auto-ApplyRN Clinical Operations Specialist - Home Health
Clinical research coordinator job in Brentwood, TN
The Clinical Operations Specialist is responsible for the agreed-upon clinical activities that help facilitate and improve the day-to-day clinical operations within an office. The position will be multifunctional that focuses on overall clinical and operational coordination and creating efficiencies with standardization.
Essential Duties and Responsibilities:
+ Participates in new hire clinical reviews
+ Facilitates clinical orientation and competency evaluation for new hires
+ Facilitates annual competency evaluation and clinical education on new initiatives
+ Facilitates Novice Nurse Program, Skills Advancement Program, and clinical rotation of nursing students
+ In consultation with office leadership (clinical and operations) monitors progress of plans of correction (CPOC, State survey and regulatory agency action plans). Also, identifies trends and areas for improvement and will work with office leadership to implement corrective actions
+ Facilitates and monitors quality improvement activities (including documentation review) and action plans, including data integrity, progress to goals and development of new quality improvement activities
+ In consultation with office leadership (clinical and operations) assist in compliance, legal and employee relations concerns, reports and issues
+ In consultation with office leadership (clinical and operations) assist in grievance concerns, reports and issues
+ In consultation with office leadership (clinical and operations) assist in incident report management , trending and analytics
+ Initiates creative work flow process improvement
+ Participates in office based meetings including staff meetings, quality meetings and red zones
+ On a quarterly basis completes home visits, as applicable
+ May participate in on-call
+ May serve in the capacity of office administrator, appointed by and reporting to the Governing Body, and responsible for all day-to-day operations of the office. Those duties include ensuring that a clinical manager and operations manager is available during all operating hours; and ensuring that the office employs qualified personnel. In addition, if serving in the role of administrator, ensures that a qualified alternate administrator is selected and approved by the Governing Body to fulfill the role in the absence of the administrator
+ Performs other duties as assigned
Minimum Requirements:
+ Active Registered Nurse (RN) license required in states in which office and patients are located required
+ Must meet all federal, state and local contract and program requirements in addition to internal certifications and training as required
+ Must maintain annual clinical competency
+ Preferred supervisory experience or experience leading a work-group or small group project preferred
+ Excellent written and verbal communication skills preferred
+ Demonstrated critical thinking skills preferred
+ Experience in quality management preferred, including root cause analysis training and data analytics
+ Knowledge of Microsoft Office and computer literacy is required
+ Comfortable working independently and multitasking preferred
+ Proficiency in the English language is required
Compliance & Ethics Expectations:
+ Participates and successfully completes the company's compliance program requirements and adheres to the Code of Conduct, Company policies, and applicable federal and state requirements
+ Sets an example for other employees regarding how the Company's Code of Conduct and Compliance Program is applied and observed every day when dealing with customers, business operations, or other team members
+ Reports potential violations of company policy, Code of Conduct, and/or applicable laws and regulations to the company hotline, through the chain of command, to the Compliance and Ethics Department, or through other channels made available by the company for reporting potential violations
+ Promotes an environment in which other employees are encouraged to report potential violations
+ As appropriate, provides input and suggestions regarding areas in which policies, procedures, workflows, and/or controls can be improved to enhance compliance
Compensation Details: $70,000 - $75,000 plus annual bonus potential of $5,000, paid out quarterly
Maxim Benefits:
Health and Wellness Medical/Prescription, Dental, Vision, Health Advocacy (company paid if enrolled Medical) and Health Advocate Employee Assistance Program
Retirement and Financial Security: Employee Assistance Program, Health Savings Account, 401(k) + Company Match, Profit Sharing, Short and Long Term Disability, Primary Caregiver Leave, Parental Leave, Life and Basic Accidental Death & Dismemberment Insurance, Voluntary Group Life Insurance and Supplemental Accidental Insurance, Hospital Expense Protection Plan, Critical Illness Insurance, Dependent Care Flexible Spending Account, Home and Auto Insurance discounts, Pet Insurance and Legal benefits
Lifestyle Benefits: Paid Time Off and Company Paid Holidays, Transportation Benefits, Educational Assistance Program, College Partnership Program and Employee Discount Program
*Benefit eligibility is dependent on employment status.
About Maxim Healthcare
Maxim Healthcare has been making a difference in the lives of our patients, caregivers, employees and communities for more than 30 years. We offer private duty nursing, skilled nursing, physical rehabilitation, companion care, respite care and behavioral care for individuals with chronic and acute illnesses and disabilities. Our commitment to quality customer service, compassionate patient care, and filling critical healthcare needs makes us a trusted partner wherever care is needed.
Maxim Healthcare, Inc. ("Maxim") is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Clinical Scribe (3886) KY ENT NICHOLASVILLE RD
Clinical research coordinator job in Lexington, KY
The Clinical Scribe's primary duty is to accurately and completely document the details of the office visit as dictated by the provider into the electronic medical record. The clinical scribe may also perform various patient-oriented tasks under the supervision of a nurse or physician as assigned. Employee must maintain a positive relationship with patients, family members, other department visitors, and fellow employees; performs some technical and clerical procedures associated with routine office visits.
PREFERRED QUALIFICATIONS:
Formal training which will probably be indicated by a high school diploma or equivalent; Medical Terminology; typing skills at least 55 wpm; experienced with computers/data entry; experience working with the public; ability to maintain composure when confronted with fast-paced and stressful situations; pleasant attitude; neat appearance; excellent communication skills;
PHYSICAL GUIDELINES:
Physical guidelines include the ability to move, traverse, position self, remain in a stationary position and negotiate steps for up to eight hours per day; lift, move and transport patients and materials; manual dexterity and motor coordination; articulate speech; read and understand medical information; visual acuity and ability to distinguish colors.
NOTE:
This document is intended to describe the general nature and level of work performed. It is not intended to act as an exhaustive list of all duties, skills, and responsibilities required of personnel. Attendance is an essential function of the job.
LEXINGTON CLINIC IS AN EQUAL OPPORTUNITY EMPLOYER (EOE)
Auto-ApplyClinical Research Coordinator 3
Clinical research coordinator job in Jefferson City, TN
CLINICAL RESEARCH COORDINATOR 3 To work as an integral member of the Rovia/Investigator site staff, maintaining the day-to-day operations and assist in the development of the Rovia network. This includes planning, coordinating, and executing clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and Rovia SOPs and any relevant local guidelines and regulations. Duties/Responsibilities:
Manages site selection visits and coordinates study startup activities (e.g., Source Data ID log, recruitment plan, site blinding plan, and temperature log).
Oversees facility issues in collaboration with the Site Manager and Director, and leads weekly site meetings.
Manages investigator signature processes and supports study recruitment and contingency planning.
Monitors and tracks pre-screening, enrollment efforts, and progress toward study enrollment goals, addressing delays or changes promptly.
Identifies difficult-to-enroll studies and collaborates with the recruitment manager to improve enrollment.
Ensures timely data entry in EDC and Clinical Conductor platforms and resolves any issues.
Leads or attends study initiation, interim monitor, and close-out visits.
Reviews site monitor reports, follows up on action items, and conducts quality checks on subject visits.
Collaborates with site managers and compliance teams to identify and address quality issues.
Works with the Source Document Specialist to ensure source documents are ready for patient visits.
Provides support and guidance to site research staff, including training, troubleshooting, and resource management.
Acts as a liaison between the site, financial team, and management, and suggests improvements to workflows.
Develops and maintains investigator relationships, providing regular progress reports.
Onboards and trains new staff, tracks their progress, and addresses gaps in training.
Participates in site staff evaluations and new employee interviews.
Serves as a mentor and fosters a positive work environment.
Conducts presentations at company training events and collaborates on external relationships for specialized study protocols.
Supports special projects, business development, team building, and writing SOPs.
Perform other duties as assigned.
Required Skills/Abilities:
Sound knowledge of medical terminology.
Sound knowledge of ICH/GCP and Regulatory requirements.
Excellent interpersonal and organizational skills.
Proficient in the use of Microsoft Office and Excel.
Fluent in spoken and written English.
Ability to work independently and in a team environment.
Ability to maintain confidentiality.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Education/Experience:
High school diploma required, bachelor's degree in related field of study preferred.
Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or within 6 months of role acceptance.
3+ years of CRC experience preferred, preferably working on industry-sponsored trials.
Strong regulatory experience highly preferred.
License/Certification status with appropriate CEUs, if applicable.
Cardiopulmonary resuscitation (CPR)
International Air Transport Association (IATA)
Good Clinical Practice (GCP)
Schedule:
Day shift
Monday to Friday, 8:30AM-5:00PM
Clinical Coordinator
Clinical research coordinator job in Owensboro, KY
Job Description
The position requires a minimum of a master's degree in social work or a related field AND the accompanying certification (CSW, MFT, LCPA) with a preference given to a clinical license (LCSW, LMFT, or LPCC) Preference given to candidates who have completed a practicum working in behavioral health and substance use issues.
Responsible for the overall Clinical services to families in the Family Recovery Program, to include children. It requires a reasonable combination of the following knowledge and skills; Work with individuals with substance use disorder, ability to use and implement cognitive behavioral therapies and use of community resources and ability to serve as an appropriate role model. Compassion towards people living with mental illness, substance abuse disorders, and HIV/AIDS and ability to convey respect to the target populations are critical. Must learn and apply agency, personnel and program policies and procedures. Must have knowledge and understanding of the current treatment modalities. Preference given to those that have the ability to train and supervise other clinical staff and interns. Must be willing to be on-call and work some evenings if applicable.
SPECIAL REQUIREMENTS:
Satisfactory criminal records check.
Satisfactory sex crimes records check.
Driver's license preferred.
PRINCIPAL ACTIVITIES:
Manage caseload and client needs
Work effectively with referral sources.
Document services through current, complete record
Counseling on personal, family financial, employment, behavioral, crisis and substance abuse matters.
Advise other staff on treatment matters and coordinate team treatment as appropriate.
Discuss and review client progress
Participate in regular client review.
Maintain a current CPR and First Aid certificate.
Participate in weekly clinical supervision.
Conduct group and individual sessions daily.
Maintain billing requirements.
Performance quality improvement (PQI) duties as assigned by supervision & PQI committee.
EFFECT ON END RESULTS:
To model agency core values of integrity, compassion, diversity, commitment & justice to all internal and external contacts.
About AMS:
AMS is dedicated to helping find the perfect fit for your schedule and personal goals. Because AMS has been in the Kentuckiana area for over 45 years, we have direct partnerships with many providers, including long-term care facilities, behavioral healthcare facilities, physician offices, outpatient care centers, adult day care centers, private duty, and more. This wide variety of locations and facilities gives you more opportunities to find the perfect fit.
Clinical Associate - PRN ARCH Boys
Clinical research coordinator job in Pegram, TN
Job DescriptionDescription:
ARCH
We are looking for you! Do you want to be a part of the team that transforms lives? ARCH Academy is more than a campus on 67 acres, it's a community. Our mission is providing the highest quality care possible for persons and families who are at risk for or who are suffering from the disease of chemical dependency. Treatment encompasses the physical, mental, emotional, and spiritual dimensions of recovery by offering a safe, loving and healing environment, combining professional excellence and the principles of the Twelve Steps.
Cumberland Heights Foundation offers a comprehensive benefits program, which includes:
· Medical, Dental and Vision effective 1st day of month following 28 days of employment
· Employer Contribution for Health Saving Account or Health Reimbursement Account
· 401K with Company match and eligibility after 90 days of employment
· Paid Time Off (PTO) accrual beginning day (1) one and up to 20 days of PTO the first year
The Clinical Associate supports Cumberland Heights' mission of transforming lives, giving hope and healing to those affected by alcohol or drug addiction.
POSITION SUMMARY
The Clinical Associate is responsible for assisting counseling staff members with providing direct and indirect services to a specified group and/or population of patients, including facilitation of a safe and therapeutic milieu. In addition, the Clinical Associate assists counseling staff in assessing the patients' daily needs, as well as assisting them to become involved in their own treatment and recovery experience.
PRIMARY DUTIES AND RESPONSIBILITIES include some or all of the following depending on assigned area and shift:
Provides information, including formal and informal orientation, to patients or family members regarding clinical programs and services including content, schedules, guidelines, etc.
Helps to create a welcoming, safe and healing environment is maintained for each patient and family throughout the continuum of care.
Assists counseling staff with assessment, both initial and ongoing, by data collection and direct observation of the patient and/or family within the therapeutic milieu.
Assists in performing luggage and personal property searches.
Provides addiction and recovery related psycho-education to individuals, groups, and families as assigned, as well as facilitating and/or coordinating community groups, in-house and outside 12 step meetings, and 12 Step discussion/study groups.
Transports patients to 12 Step meetings and/or other therapeutic recreation activities as assigned, operating company vehicles within the guidelines of the Fleet Management Safety Program.
Assists Activities Services staff members with recreation, art, music, and adventure based therapies as assigned.
Manages the patient community as a therapeutic milieu, holding patients and families accountable for behavior consistent with community guidelines and recovery.
Intervenes in clinical and community crises in such a manner as to use crises for therapeutic value.
Assists in de-escalation and management of crises, including performing CPR and First Aid as needed
Participates in team meetings, treatment plan reviews, staff meetings, and quality management teams, as assigned
Documents pertinent clinical information into the electronic patient record.
May assist in providing transportation for admitting and existing patients.
Recommends ways to improve the quality and delivery of services.
Ensures proper handling and distribution of company funds.
Maintains confidentiality of company and patient information.
Reacts productively to change.
Performs other duties as assigned.
SUPERVISORY RESPONSIBILITIES
None
Requirements:
High school diploma or GED is required with Bachelor's degree preferred
One (1) year experience in addictions treatment preferred
CPRS certification is preferred but not required.
Valid Tennessee Driver's License preferred (may use company van to transport patients)
Intermediate computer skills including Microsoft (Outlook, Word and Excel)
Ability to quickly learn and use various clinical software.
Ability to problem-solve, analyze, and interpret information.
Ability to adapt to changing circumstances and patient needs in a fast-paced environment.
Ability to analyze complex situations and make crucial decisions while also knowing when consultation is needed.
Ability to be open and culturally sensitive to a wide variety of patients' experiences.
Excellent written and oral communication skills with the ability to effectively speak, read and write in English.
Ability to interact with patients and co-workers in a collaborative and courteous manner while providing guidance, instruction, and/or training.
Ability to model/teach the 12 Step programs and philosophy.
Reacts productively to change.
Ability to deescalate a person in crisis in a calm and supportive manner; work calmly and professionally in stressful situations and ally with people in crisis.
Ability to present to hostile or disinterested groups.
If recovering, eighteen months of verifiable abstinence required; active participation in a twelve-step program preferred.
WORK ENVIRONMENT
Position is on a campus setting that involves walking outside to various buildings and everyday risks or discomforts requiring normal safety precautions.
Position requires frequent contact with people in crisis, including those who are emotionally volatile and may require additional safety precautions.
May perform CPR/First Aid as needed (being certified or eligible is required)
Position is subject to varying shifts, including weekends as well as staying overnight for inclement weather as part of critical staffing, along with some travel to other off-site Cumberland Heights facilities/campus
Ability to lift up to 20lbs and/or push pull up to 40lbs; move around campus on uneven and rural terrain.
Ability to speak, hear, see, sit, walk, stand, reach, and use fine/gross motor skills.
Clinical Research Associate II
Clinical research coordinator job in Nashville, TN
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Coordinator - Level 2
Clinical research coordinator job in Knoxville, TN
CRC Level I - Knoxville, TN (Onsite)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC 2 ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC 2 will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. They will assist the Manager of Clinical Operations and Senior CRCs with staff development through mentoring and site level quality assurance.
This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.
Location: Onsite (1200 Merchant Drive, Knoxville, TN 37912)
What you will be doing:
Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
Proactively develops and executes recruitment plans that meet and exceed enrollment goals
Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
Attends investigator meetings
Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
Accurately collects study data via source documents/progress notes as required by the protocol
Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
Dispenses study medication at the direction of the Investigator
Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
Your Profile:
2+ years of patient-facing Clinical Research Coordinator experience
Strong attention to detail
Motivated about a career in clinical research
Excellent time management and planning skills with an organized approach to work
Bachelor's degree in life sciences or other related field
#LI-Office
#LI-TP1
#LI-Accellacare
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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Auto-ApplyClinical Research Coordinator II
Clinical research coordinator job in Memphis, TN
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
* 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
* Licenses:
* 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: Memphis, TN
* This is a part-time temporary role lasting for 6 months
* Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
* Type of travel required: Regional (within 100 miles)
* Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
* Walking - 20%
* Standing - 20%
* Sitting - 20%
* Lifting - 20%
* Up to 25lbs
* Over 25lbs
* Overhead
* Driving - 20%
The expected salary range for this role is $60,000 - $90,000 USD per year 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 Coordinator 1
Clinical research coordinator job in Lexington, KY
The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study.
To consistently embody AMR Clinical's Core Values:
United We Achieve
Celebrate Diverse Perspectives
Do the Right Thing
Adapt and Persevere
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
Establish understanding of SOP's and implement the SOP's
Gain understanding of the pharmaceutical drug per clinical trial.
Develop detailed knowledge of protocol and procedures per clinical research study.
Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry.
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.
Establish and maintain patient rapport.
Clinical data collection (vital signs, EKG recording, weight, height, etc.)
Obtain medical records and review as required.
Phlebotomy
Specimen collection, processing, and storage
Transporting clinical specimens to the laboratory.
Educate subjects on diaries and oversees compliance with diary completion.
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
Responsible for completing patient phone call visits in accordance to the standard protocol period.
Ensure documentation follows ALCOA standards and is completed in a timely manner.
Ensure all necessary documents are completed, signed and dated.
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
Manage study inventory and order supplies as needed.
Prepare and assist study monitors during onsite visits.
Maintain familiarity with all ongoing clinical research studies.
Travel to Investigator meetings as needed.
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
Position may require occasional weekend and/or overtime hours.
Other duties as assigned
Desired Skills and Qualifications:
1 year of experience in clinical research.
Completion of formal medical training, educational program, or healthcare experience
Strong medical terminology
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
Ability to work independently and lead study-related tasks.
Ability to multi-task in a high-paced evolving environment.
Exceptional listening, written, and verbal communication skills as well.
Demonstrate proficiency in office equipment and software programs.
Excellent organizational and task management skills.
Ability to be ambulatory most of the workday.
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
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