Clinical Research Scientist
Clinical Research Coordinator Job 440 miles from Johnson City
St. Jude Children's Research Hospital has spent more than a half-century conducting research into catastrophic diseases in children, including cancer, hematological disorders, and various infections (e.g., pandemic viruses and HIV). St. Jude Children's Research Hospital is dedicated to researching and treating pediatric malignancies. The mission of the Comprehensive Cancer Center at St. Jude Children's Research Hospital is to advance cures and means of prevention for pediatric cancer, the leading cause of disease-related death in children. The St. Jude Comprehensive Cancer Center supports several multidisciplinary research programs organized with the intent of translating basic science discoveries into curative therapies for children with cancer while minimizing long-term side effects.
The Multimodal Functional Brain Imaging and Neuromodulation Research Program directed by Dr. Ranganatha Sitaram, under the Department of Radiology in St. Jude is developing a novel research program to acquire cognitive and psychosocial data on childhood catastrophic diseases (e.g., cancer, sickle cell disease, neuromuscular and developmental disorders) for characterizing and predicting the effect of the childhood diseases and their treatment on sensory, perceptual, cognitive and emotional aspects of brain function and behavior, and for developing interventions with neuromodulation and neurostimulation techniques to reverse the adverse cognitive effect of pediatric cancer. This new program would heavily involve the application of multimodal functional brain imaging, such as functional magnetic resonance imaging (fMRI), functional Near Infrared Spectroscopy (fNIRS), electro/magnetoencephalography (EEG/MEG), and neuromodulation techniques, such as low intensity focused ultrasound stimulation (FUS), closed-loop fMRI, EEG, and fNIRS neurofeedback, combined with novel experimental paradigms. In addition, novel computational neuroscience and artificial intelligence methods, including functional and effective connectivity, causality modeling, real-time imaging, brain-computer interfaces, and neurofeedback, would be key tools for scientific investigation and translational intervention in this new research program.
We are looking for a talented and motivated research scientist to fill the position of Neuromodulation Research Scientist. The candidate is expected to have completed a PhD or equivalent in neuroscience, biomedical engineering, biomedical sciences, electronic/electrical engineering, physics, mathematics, computer science, psychology, or related areas. In addition, the candidate should have completed a post-doctoral position for at least two years. Candidates with prior experience and published literature in neuromodulation and neurostimulation (e.g., FUS, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), closed-loop neurofeedback), will be highly preferred. Other requirements include demonstrated expertise and ability to conduct experimental work on humans or animal models, analytical and computational techniques skills, and excellent written and spoken communication skills. Candidates demonstrating peer-reviewed journal publications, patents, and conference presentations are preferred.
Job Responsibilities:
Lead clinical research design and implementation activities (e.g., experimental design review; identification of appropriate research procedures/methodologies QC procedures finalization; design and testing of data collection instruments; project-specific protocol compliance oversight).
Assist with the management of large, multidisciplinary research operations and the instruction of research staff.
Oversee execution of multiple concurrent projects/studies.
Oversee/coordinate engagement with study participants and related outcomes (e.g., interviewer scripts, informed consent, data entry, procurement of medical record/specimens).
Coordinate communication with principal investigators across multiple sites to anticipate, clarify, and address needs for efficient conduct of research.
Present/publish results, insights, and outcomes both internally and externally to multi-disciplinary audiences.
Provide ongoing instruction and guidance to staff and train as needed.
Perform other duties as assigned to meet the goals and objectives of the department and institution.
Maintains regular and predictable attendance.
Minimum Education and/or Training:
MD or PhD in relevant scientific field (neuroscience, biomedical engineering, biomedical sciences, electronic/electrical engineering, physics, mathematics, computer science, psychology, or related areas) required.
Minimum Experience:
Minimum Requirement: 2+ prior relevant and productive research experience in clinical/population-based outcomes and health behavior research.
Experience in study design methodology, protocol development, study conduct, and analysis.
Experience working in a project-oriented matrixed team environment preferred.
Candidates with prior experience and published literature in neuromodulation and neurostimulation (e.g., FUS, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), closed-loop neurofeedback), will be highly preferred.
Demonstrated expertise and ability to conduct experimental work on humans or animal models preferred,
Candidates demonstrating peer-reviewed journal publications, patents, and conference presentations are preferred.
Proven performance in earlier role.
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $86,320 - $154,960 per year for the role of Clinical Research Scientist.
Explore our exceptional benefits!
Diversity, Equity and Inclusion
St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment.
Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.
St. Jude is an Equal Opportunity Employer
No Search Firms
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
Clinical Research Coordinator
Clinical Research Coordinator Job 254 miles from Johnson City
Role
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, research team, and sponsor to support the administration of the compliance, financial, personnel and other related aspects of the clinical study. The CRC will also work under the direction of and report to the Clinical Research Director.
Responsibilities
? The CRC's primary responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI and sponsor to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
? Coordinates with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations, site-specific policies and procedures, and sponsor required policies and procedures.
? Maintains effective and ongoing communication with the sponsor, research participants, appropriate CTC staff and PI during the course of the study.
? Works with the PI to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
? Reviews and comprehends the protocol, investigator brochures (when applicable), and all study-related manuals/guidelines.
? Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
? Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
? Prepares study-related documentation, including but not limited to source documents, adverse event reports, and progress notes.
? Establishes and organizes study files, including but not limited to study-specific source documentation and other materials.
? Attends investigator meetings as required or requested by the PI.
? Participate in after hours call from time to time as requested by Management.
? Assists PI in communicating study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members-documents date of training and signatures of study personnel trained on the study-specific training log.
? Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
? Conducts or participates in the informed consent process, including interactions and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
? Conducts procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures.
? Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
? Coordinates participant tests and procedures.
? Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
? Collects data as required by the protocol. Assures timely completion of Case Report Forms.
? Maintains study timelines.
? Maintains an adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Clinical Trials Center of Middle Tennessee, LLC SOP on Investigational Drug/Device Accountability.
? Completes study documentation and maintains study files in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
? Maintains all study records, including but not limited to case report forms, drug dispensation records, or regulatory forms in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
? Coordinates appropriate and timely payments to participants (if applicable) in accordance with Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
? Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
? Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem-solving efforts such as protocol revisions.
? Coordinates and facilitates monitoring and auditing visits.
? Collaborates with PI and institution to respond to audit findings and implement approved recommendations.
? Notifies appropriate institutional officials of external audits by FDA and sponsors.
? A great CRC possesses excellent verbal and written communication skills. Ensure Participant Understanding: When communicating with participants, the CRC should be able to explain a complex research protocol at the patient's level of understanding.
Tools for Success
The Anatomy of a Great Clinical Research Coordinator
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Benefits:
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Preferred)
Experience:
Clinical research Coordinator: 2 years (Required)
Skilled in performing phlebotomy (venipuncture)
PIc6504b12322e-26***********2
Enrollment Research Nurse
Clinical Research Coordinator Job 248 miles from Johnson City
It's More Than a Career, It's a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
As an Enrollment Research Nurse your primary responsibility is to screen and enroll oncology research study subjects ensuring protocol compliance.You willenroll patients onto clinical trials through recruitment, screening, enrollment and follow-up of eligible subjects.
You will be familiar with the protocols on which the patients are enrolled, screen, treated.
You will review the study design and inclusion/exclusion criteria with physician and patient.
You will complete and document screening/eligibility and consent accurately and have all parties fully execute the document including HIPAA Authorization
You will complete the inclusion/exclusion form and standard enrollment form accurately and assess the patient and document findings at each clinic visit while on protocol
You will document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs
You will complete the study medication order form and have the physician or nurse practitioner sign orders prior to treatment and ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies and accurately calculate and the BSA, creatinine clearance, urine protein:creatinine ratio or any other conversions needed per protocol
You will obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols and re-consent patients in a timely manner and document process appropriately
What you should have for this role:
Associate of Nursing Degree; Bachelor of Nursing is preferred.
Nursing license for the State of Tennessee
Knowledge of medical and oncology research terminology and of federal regulations, good clinical practices (GCP).
One year of clinical nursing experience
One year of clinical research experience is preferred
One year of experience treating oncology patients is preferred
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
By applying, you consent to your information being transmitted by Zippia to the Employer, as data controller, through the Employer's data processor SonicJobs.
See McKesson Privacy Policy at **************************************************************************************** and SonicJobs Privacy Policy at ******************************************* and Terms of Use at *********************************************
Clinical Research Associate - Oncology - Central Region
Clinical Research Coordinator Job 248 miles from Johnson City
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple oncology trials + Quality of life focus wtih Regional Travel
+ Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team
+ Acts as Lead SM-training other SMs on study
+ Develops site start up documents for studies including SIV agenda
+ Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines)
+ Represents LTMs or SMs on SMTs/meetings
+ Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
+ Supports country budget development and/or contract negotiation in liaison with CCS colleagues
+ Assists with ASV
+ Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
+ Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
+ Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
**Qualifications Needed:**
+ Based in the Tennessee (near a major airport)
+ Have a minimum of a B.Sc (********************************************************************** ., R.N., or equivalent degree, preferably in Biological Sciences
+ Have a minimum of 2 years' experience in monitoring pharmaceutical industry clinical trials
+ Have a minimum of 1-3 years' experience monitoring Oncology trials
+ Knowledge of several therapeutic areas, with oncology an asset but not a requirement.
+ Analytical/risk-based monitoring experience is an asset
+ Ability to actively drive patient recruitment strategies at assigned sites
+ Ability to partner closely with investigator and site staff to meet all of our study timelines
+ Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
+ Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
+ Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
+ Need to travel up to 50%
+ To qualify, applicants must be legally authorized to work in US, and should not require, now or in the future, sponsorship for employment visa status
**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 maximise 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 website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below.
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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.
Clinical Research Associate II
Clinical Research Coordinator Job 248 miles from Johnson City
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
Dual Enrollment & Federal Work-study Coordinator
Clinical Research Coordinator Job 248 miles from Johnson City
Title: Dual Enrollment and Federal Work-study Coordinator
Administration of the Dual Enrollment/Middle College Grant programs and the Federal Work-Study (FWS) Program.
ESSENTIAL JOB FUNCTIONS/JOB DUTIES AND RESPONSIBILITIES
Responsible for maintaining a thorough understanding of the state guidelines applicable to the Dual Enrollment and Middle College grant processes. Responsible for administering and reconciling the Dual Enrollment and Middle College grant programs. Coordinate with the Director of High School Programs to gather the information needed to award students. Serve as a backup member of the SAP and IRP committees for appeals. Responsible for maintaining a thorough understanding of the federal regulations applicable to the Federal Work-Study program.
Responsible for administering the Federal Work-Study program, including working with students for job placement, hiring packets, verifying timesheet figures, ensuring compliance with federal regulations.
Serve as a liaison with our Community Service Partners to ensure that at least 7% of our total FWS allotment is spent on community service (including at least one reading tutor) each year. Responsible for working extended hours as needed to accomplish work assignments, inclusive of working extended hours during registration periods. Responsible for designing and presenting FWS Orientation sessions for students in the FWS program.
REQUIRED QUALIFICATIONS
Bachelor's degree
2 years of related experience in customer service
PREFERRED QUALIFICATIONS
2 years of financial aid experience
Experience in higher education
Prior experience administering the Dual Enrollment Grant or Federal Work-Study program
Prior experience with Banner, FAST, COD, Excel, and D2L
NASFAA Credentials
KNOWLEDGE, SKILLS AND ABILITIES
Attention to detail and ability to maintain a heavy workload with minimal errors is essential. Effective oral and written communication skills. Excellent customer service skills. Working knowledge of regulations governing federal, state, and institutional policies regarding the administration of financial aid. Ability to interpret and apply guidelines and regulations related to Dual Enrollment and Federal Work-study programs. Ability to work independently with minimal supervision.
Open Until Filled: Yes
Rate of Pay: $45,006.00 - $54,015.00 depending on experience
Special Instructions to Applicants: Unofficial transcripts are acceptable for the application process. Official transcripts are required upon hire. Applicants may be subject to a background check.
Nashville State offers flexible work arrangements for positions that qualify.
Senior Clinical Project Manager, Immuno-Oncology - IQVIA Biotech
Clinical Research Coordinator Job 33 miles from Johnson City
We are seeking candidates with experience managing on Immuno-oncology & cell and gene therapy trials. Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Senior Project Lead is an essential member of the core project team leading the team and responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads run their own studies. The Senior Project Lead focus is on leveraging therapeutic expertise and IQVIA's suite of solutions to drive operational excellence and strategic leadership with our customers.
Essential Functions
- Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for, multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalize the agreed upon approach.
- Develop integrated study management plans with the core project team.
- Accountable for the strategic planning and execution of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
- Responsible for delivery and management of medium to large sized, multiple and full service, multi regional studies.
- Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.;
- Serve as primary project contact with customer and own relationship with the project's key customer contact(s)
- Communicate/collaborate with IQVIA business development representatives as necessary.
- Build the cross-functional project team and lead their efforts, responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
- Ensure the financial success of the project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Identify changes in scope and manage change control process, as necessary.
- Identify and communicate lessons learned and best practices to promote continuous improvement.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
- Provide input to line managers of their project team members' performance relative to project tasks. Support staff development.
- Mentor less experienced project team members on assigned projects to support their professional development.
Qualifications
- Bachelor's Degree Life sciences or related field
- Requires greater than 7 years clinical research experience including 4 years project management experience or equivalent combination of education, training and experience.
- Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.;
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Communication - Requires strong negotiation and customer management skills.
- Problem solving - Strong problem solving skills.
- Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross
functionally and with customers to advance work effectively and efficiently.;
- Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.;
- Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
- Prioritization - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
- Quality - Attention to detail and accuracy in work.
- Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
- IT skills - Good software and computer skills, including MS. Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
- Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
- Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
- Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
- IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. **********************/eoe
IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. **********************/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $112,000.00 - $186,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Clinical Research Coordinator
Clinical Research Coordinator Job 278 miles from Johnson City
All Employees of Premier Medical Group are required to demonstrate our core values of Integrity, Respect and Compassion throughout their employment with us, placing patients first. Our employees must commit to always acknowledging our patients positively; showing genuine concern for their needs, identifying themselves and how they and others on the team can help, keeping patients informed and offering thanks for choosing and trusting us with their healthcare needs.
Job Purpose: Coordinates and administers research study associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, performs research study visits, maintains study documentation, data, study medication and works directly with the Director of Clinical Research and Principle Investigator to ensure protocol adherence and patient clinical care are provided to each study patient.
Essential Functions
* Understand the given study protocol and aspects of implementing the protocol.
* Assist the PI in training all key research personnel in understanding and implementing to study protocol.
* Assist the PI in recruiting and screening potential research study patients.
* Review EMR and patient medical history and medication lists to ensure adherence to the specific inclusion/exclusion criteria in the IRB approved protocol.
* Review and understand the current approved study specific Informed Consent Form (ICF) to ensure it has been IRB approved and provides adequate information to the patient including what is required for the patient, their risk in study participation, who can access their information, how they can withdraw, whom they should contact and that the PHI is explained.
* Assist the PI in performing the consenting process and helps to ensure the consent process occurs following the GCP guidelines and Premier Medical Group's SOPs such that the patient is allowed to ask questions and given time to review the ICF prior to signing.
* Assist the PI in assuring amended consent forms are appropriately implemented and signed.
* Schedule and coordinate participant visits and ensure that all appropriate study procedures are completed and documented.
* Collect patient vitals such as weight, height, blood pressure, pulse, ECG, etc.
* Collect data as required by the protocol and complete case report forms as well as address any queries on data.
* Collect all required lab data and other procedures for the PI to review and sign off on.
* Collect any adverse events or unexpected outcomes to the PI.
* Assist the PI and research team in reporting any unexpected events, protocol deviations, violations, incidents or patient complaints.
* Dispense, review and collect patient study medication.
* Maintain study files in accordance with sponsor, IRB and Premier Medical Group requirements.
* Maintain effective and ongoing communication with the PI, Director of Clinical Research, sponsor research team, and research participants during the course of the study.
* Help schedule and facilitate sponsor monitoring visits, and any audits that may occur.
* Work with the PI and research team to manage the day-to-day activities of the study including problem solving, protocol management and patient care.
* Performs other duties as assigned.
* Maintains confidentiality.
Qualifications
Education: High school diploma or equivalent; graduation from an accredited medical assisting or nursing program preferred.
Experience: Minimum of 1 year clinical experience in an outpatient medical office using an EHR, preferred.
Knowledge and Skills: Knowledge of examination, diagnostic and treatment room procedures. Knowledge of common safety hazards and precautions to maintain a safe work environment.
Skill in taking vital signs. Skill in maintaining records and recording test results. Skill in establishing and maintaining effective working relationships with patients, staff and the public.
Ability to maintain quality control standards. Ability to react calmly and effectively in emergency situations. Ability to read, understand and respond to detailed oral and written instructions. Ability to communicate clearly.
Licenses/Certifications: Valid state nursing license, if applicable. CPR certification.
Lead Clinical Research Coordinator-Memphis, TN
Clinical Research Coordinator Job 440 miles from Johnson City
What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Lead CRC is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Lead CRC is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials. The Lead CRC will also carry a full study load.
What You'll Be Working On
Duties include but not limited to:
Site Support Responsibilities:
Primary point of contact for the site
Supports Key Sponsors and CROs
Manages some of the sites most challenging therapeutic areas and study designs
Able to monitor and mentor all levels of CRCs to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
Assist Region Manager and Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits
Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager
Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
Study Preparation:
* Ability to understand and follow institutional SOPs
* Collaborate with PI to review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
* Work closely with Central Teams to ensure that all training and study requirements are met prior to trial conduct
* Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
* Assist with planning and creation of appropriate recruitment materials
* Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database
* Actively work with the recruitment team in calling and recruiting subjects
* Attend Investigator meetings.
* Coordinate and attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives and report summary to the Region Manager if they are not in attendance
* Assist in the creation or review of sponsor-provided protocol specific source documents
* Determine facility, equipment and outsource vendor requirements and availability
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)
* Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
* Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
* Work with Region Manager to identify and communicate staff needs
* Ensure there are adequate supplies and equipment on site
Study Management:
* Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines
* Maintain organized files for blank source documents, patient charts, CRFs, and supplies
* Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document accountability log and patient records. Temperature monitoring and compliance of IP storage conditions.
* Collect and evaluate concomitant medication
* Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
* Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the Care Access team in an ongoing fashion
* Maintain effective relationships with study participants and other Care Access personnel
* Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management
* Communicate clearly verbally and in writing
* Accept accountability for actions and function independently
Study Visit Conduct:
* Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling a screening appointment
* Collect and review medical records against study Inclusion/Exclusion criteria
* Obtain informed consent per Care Access SOP
* Complete delegated visit procedures and ensure proper specimen collection, processing, and shipment in accordance with the protocol
* Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values ensuring investigator review in a timely fashion
* Record adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and Regulatory team following all applicable guidelines
* Schedule participants within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedules to maximize efficient workflow and positive participant experience
Documentation:
* ALCOA-C: Record data legibly, in real-time on source documents; note additional information that may assist with the causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
* Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion
* Accurately transcribe data to eCRF. Resolve data management queries and correct source data timely
* Enter all Quality issues into QMS and report protocol deviations to sponsor
* Work closely with Regulatory Team to ensure all documents are uploaded into eReg system
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Physical and Travel Requirements
* This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.
* Ability to work evenings and weekends as needed
* Must have access to reliable transportation
What You Bring
Knowledge, Skills, and Abilities:
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability and willingness to mentor and train site staff
Ability to communicate and work effectively with a diverse team of professionals
Excellent organization, prioritization, and leadership skills with strong attention to detail
Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
Critical thinker and problem solver
Excellent interpersonal skills, detail-oriented and meticulous
Friendly, outgoing personality with the ability to 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 and as a team player working together towards common goals
Certifications/Licenses, Education, and Experience:
* Bachelor's Degree or equivalent professional experience
* Research Professional Certification preferred
* A minimum of 5 years of Clinical Research Coordinator experience
Benefits (US Full-Time Employees Only)
● PTO/vacation days, sick days, holidays.
● 100% paid medical, dental, and vision Insurance. 75% for dependents.
● HSA plan
● Short-term disability, long-term disability, and life Insurance.
● Culture of growth and equality
● 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Johnson City
If you are a motivated and reliable person with exceptional customer service skills and the ability to thrive in a fast-paced environment, come join Holston Medical Group. We are looking for friendly, courteous employees to ensure a positive patient experience and welcome a teamwork environment.
WHAT WE OFFER:
* Company paid Life and Accidental Death and Dismemberment Insurance
* Company paid Long Term Disability Insurance
* 401(k) and Roth Retirement plan with Company Contributions
* Medical, Dental, Vision, and additional Life and STD Insurance
* Health Savings Account Plan with company contributions
* Paid time off
* Paid Sick time
* Paid Holidays
* Employee discounts
* And more!
General Summary:
The Clinical Research Coordinator is responsible for managing clinical research activities. They will screen and enroll subjects ensuring they meet inclusion and exclusion criteria. Manage study related activities, ensure subject compliance and prepare documentation. The Clinical Research Coordinator will also monitor and report adverse events to the appropriate staff members as well as complete end of study regulatory documentation.
Main Responsibilities:
Under the direction of the Principal or Sub-investigator, manage the conduct of clinical research activities.
Develop management systems and prepare for study initiation
* Assess study feasibility in terms of study's impact on site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)
* Possess a comprehensive and in-depth understanding of each protocol that has been assigned as a primary responsibility;
* Review with the principal investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol;
* Review the protocol summary sheet and the informed consent form for accuracy and clarity;
* Develop source documents based on the most current IRB approved protocol and reviewed for accuracy and clarity;
* Develop a plan for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
Screen and enroll study subjects
* Review the study design and inclusion/exclusion criteria with the subject's primary physician;
* Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility;
* Review the protocol, informed consent form, and follow-up procedures with potential study subjects;
* Ensure the current approved informed consent is signed before subjects are screened and enrolled;
* Ensure that the randomization procedure is followed as per protocol guidelines;
* Document protocol exemptions and deviations and report to IRB (as required).
Manage study related activities, subject compliance and documentation
* Including related clinical duties such as performing EKGs, lab processing, and if not already qualified to perform phlebotomy - must acquire these skills.
* Ensure adherence to protocol requirements;
* Schedule subjects for follow-up visits;
* Assist investigators in assessment of subject response to therapy;
* Review laboratory data, inform investigator of abnormal values and document;
* Report to primary care provider as appropriate;
* Assess and document subject compliance with medications and visits;
* Communicate with pharmacy staff to assure timely and accurate study drug distribution;
* Manage administration of investigational therapy;
* Maintain dispensing logs (if allowed);
* Maintain copies any documentation for dispensing of investigational products and/or study-related supplies;
* Oversee specimen collection, storage, and shipment;
* Attend study-related meetings as appropriate;
* Communicate regularly with the principal investigator, monitor (others responsible for conduct of the research) about study-related issues.
Record data and study documentation
* Record data as directed using the appropriate media or platform;
* Follow procedures for access and security for electronic data entry;
* Review keyed data for accuracy as needed;
* Send data to the data collection center on a timely basis;
* Maintain source documentation for all data entered, including clinic chart visit notes, lab data, and procedure reports;
* Correct and edit data as directed and as appropriate.
Monitor and report adverse events
* Document and record all AEs as outlined in protocol with causality determined by PI or SI.
* Report serious adverse events (SAEs) to the principal investigator, sponsor, and IRB (others as required by funding source or as outlined in the protocol).
Regulatory documentation
* Know and understand all regulatory requirements associated with the conduct of the study assigned;
* Maintain files and documents as regulations dictate;
* Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc), prepare and submit reports as required;
* Ensure that all required documentation is complete and appropriately filed.
Management of site activities during audits and inspections
* Prepare for quality assurance audits and regulatory inspections as needed;
* Act as contact person before, during, and after audits and inspections;
* Provide all required documentation to auditors;
* Make all appropriate corrections as requested by auditors;
* Coordinate site response to audit / inspection findings.
Management of ancillary staff
* Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
Education/Experience/Knowledge:
* 2 year Degree or appropriate experience related to anticipated duties
* Experience in the conduct of clinical research preferred but not required for application.
* Interpersonal and communication skills - interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
"We are an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, age, national origin or disability."
Research Study Coordinator 1-Preventive Medicine
Clinical Research Coordinator Job 440 miles from Johnson City
Market Range: 08
Hiring Salary: $21.69/Hourly
JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Research Study Coordinator 1 conducts study visits with research participants for the CANDLE study protocols.
Responsibilities
DUTIES AND RESPONSIBILITIES:
Recruits' participants for new study visit by explaining the procedures and benefits of participating.
Facilitates informed consent/assent process in accordance with study protocols and Good Clinical Practice Guidelines.
Completes study visits with participants as specified in the study protocol via face-to-face meetings, telephone conversations, and mailings (print, e-mail, text).
Performs complex battery of cognitive and executive function testing with children, using validated measures.
Assesses children's health and development to ensure safety and eligibility for all study procedures.
Performs pulmonary function tests using diagnostic testing software to assess lung function in children.
Completes an intensive sequence of sensitive data collection instruments via interviews with child participants.
Performs preliminary assessment for participant safety in cases of suicidal ideation.
Obtains blood specimens from patients.
Collects, processes, and stores biological specimens collected as part of the study visit.
Manages input, storage, and retrieval of biological samples for the CANDLE study.
Documents all adverse events, medication adjustments, and/or protocol deviations reported by study participants.
Attends protocol-specific research meetings to troubleshoot any potential problems regarding assigned protocols.
Evaluates and reports on the efficacy of study protocol and contribute ideas to improve the study methodology.
Performs other duties as assigned.
Qualifications
MINIMUM REQUIREMENTS:
EDUCATION: Bachelor's Degree in Public Health, Psychology, Counseling, Sociology, or related social science field. (
Master's Degree preferred
). (TRANSCRIPT REQUIRED)
EXPERIENCE: One (1) year of clinical experience. OR Master's Degree will be accepted in lieu of experience. Must be able to receive Human Subject Protection and other applicable certifications within the first four weeks of employment. (
Experience including consenting subjects and following a research protocol preferred
)
KNOWLEDGE, SKILLS, AND ABILITIES:
Excellent interpersonal, organizational, time-management, and verbal and written communication skills.
Ability to make good clinical judgment.
Ability to function independently and as a member of a team.
Computer skills, including proficiency using Microsoft Word and Excel.
Ability to communicate clearly and effectively with a diverse group of participants, staff, and faculty.
WORK SCHEDULE: This position may occasionally be required to work weekends and evenings.
Clincal Research Coordinator II
Clinical Research Coordinator Job 229 miles from Johnson City
JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II
POSITION DESCRIPTION: The Clinical Research Coordinator II (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
1099 6 month contract full-time onsite
RESPONSIBILITIES:
Responsible for up to 10 studies and expected to perform 20-40 visits a month.
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Serves as a liaison to all physicians, AARA employees, and third party vendors.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Maintaining office supply inventory while keeping an organized office space.
Travel as necessary for Investigator Meetings and other AARR sites.
Requirements
Qualifications:
Associates Degree
1 year experience as a clinical research coordinator preferred
Must have in-depth knowledge of medical procedures and clinical terminology
Possess strong organizational skills
Excellent verbal and written communication skills
Ability to lift 20 pounds
Willing and able to travel for Investigator Meetings and other AARR sites
Clinical Research Coordinator
Clinical Research Coordinator Job 229 miles from Johnson City
Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.
Job Description
The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Eximia Research Network's SOPs.
Role & Responsibilities:
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Clinical Network's SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting and participating in the ICF process(es), ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close outreports.
Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
Apply good documentation in accordance with ALCOA-C principles when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Network confidential information
Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia Clinical Network SOPs.
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner as set forth in Clinical Trial Agreement
Ensure staff are delegated and trained appropriately and documented
Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
Create and execute recruitment strategies defined by Clinical Research Team
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
Understand product development lifecycle and significance of protocol design including critical data points
Understand the disease process or condition under study
Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing one's work on an ongoing basis and in preparation for monitor visits.
Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
Other duties as assigned
Qualifications
Education/Experience:
Bachelor's degree and 2 years relevant experience in the life science industry OR
Associate's degree with 4 years relevant experience in the life science industry OR
High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND1 year Clinical Research Coordinator experience
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role
Required Skills:
Demonstrated knowledge of medical terminology
Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Proficient ability to work in a fast-paced environment
Proficient verbal, written, and organizational skills
Proficient interpersonal and communication skills
Proficient ability to work as a team player
Proficient ability to read, write, and speak English
Proficient ability to multi-task
Proficient ability to follow written guidelines
Proficient ability to work independently, plan and prioritize with minimal guidance
Proficient ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability.
Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
Demonstrated leadership ability
Clinical Research Coordinator
Clinical Research Coordinator Job 440 miles from Johnson City
Job Details TN 8110 Walnut Run Road 0VQ48 - Cordova, TN 2 Year Degree None ResearchDescription
Have you been looking for a place to grow your skillset? Or perhaps you are looking for a place to develop your career surrounded by a diverse group where employees feel a sense of belonging.
At Gastro One we are championing the power of inclusivity and a people first mentality. We hope to improve the human experience - from our patients to our colleagues.
If you are interested in joining our culture, we're looking for a
Clinical Research Coordinator.
A little about us:
Gastro One is a team of gastroenterologists and allied health professionals with a proven track record of providing excellent care that families can count on. We specialize in treating the full range of digestive diseases and endeavor to provide exceptional care, for every patient, every time.
We are One GI , a true collaboration of the very best clinical and business minds - which enables us to focus on what's truly important - our patients.
Snapshot of Daily Duties
Administratively and clinically manage industry sponsored clinical trials.
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.
Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy.
Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
Coordinate the availability and distribution of medications for patients in a timely manner.
Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.
Facilitate assigned clinical trial from start to finish.
The Must Haves
High School Diploma or equivalent required.
Associate 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.
BLS certified.
Understanding of Code of Federal Regulations for Human Subjects.
Certified in GCP's and HSP.
Phlebotomy experience preferred.
The Perks
401k with match
Tuition reimbursement
Competitive health & supplemental benefits
Excellent paid time off for balance of work/life.
Internal growth opportunities with training and development.
Clinical Research Coordinator / Project Manager
Clinical Research Coordinator Job 248 miles from Johnson City
Clinical Research Coordinator
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.
Description:
The Clincial 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.
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.
• 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
• Bilingual Preferred
• 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.
We value our employees and their professional and personal needs, and support these through our benefit offerings:
Insurance
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.
Retirement
401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
PTO / Holidays
PTO of 16 days per year, 17 days after the first year of FT employment
9 paid Holidays
Work-Life Balance
K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.
Clinical Translational Research Coordinator III - Hybrid/Onsite, Nashville TN
Clinical Research Coordinator Job 248 miles from Johnson City
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:
VICC - Clinical Trials 40
Job Summary:
The Regulatory Coordinator III position with the Vanderbilt-Ingram Cancer Center (VICC) Clinical Trials Office (CTO) is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff.
• Demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA)
• Provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures as follows
• Serve as primary regulatory contact with the sponsoring agency for regulatory approvals
• Evaluate the protocol and sponsor documents and determine if additional items are needed for IRB/Sponsor approval
• Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and institutional requirements
• Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval
• Complete the IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly
• Manage essential documents in accordance with the sponsor, IRB and federal government requirements
• Submit amendment and continuing review data, investigate study irregularities and guide staff in reporting and documentation of events
• Submit studies for closure and resolve any outstanding relevant findings with the sponsor and/or study team
• Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB
.
KEY RESPONSIBILITIES
• 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. Participates in data quality assurance reviews.
• Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• 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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools
• Receives and tracks receipt and status of study specimens from multiple sites. 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
• Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation
• With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to 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 public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants. With guidance, assesses and evaluates potential participants pertinent medical and historical information.
• Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting
• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• People Management (Novice): Conducts performance reviews. Effectively delegates tasks to others. Coaches subordinates on technical and interpersonal topics, as well as professional development. Demonstrates team building techniques and provides leadership through personal example of good work habits, open communication and effective people relationships. Involves subordinates in decisions which affect them. Demonstrates self-reliance and resourcefulness as an example to others.
• Clinical Research (Intermediate): Demonstrates the ability to effectively research complicated issues pertaining to the area of expertise. Presents trial protocols to a steering committee. Often employs networking to help in researching issues. Sets up study centers, which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards. Has used research resources maintained in outside areas.
• Study Design & Conduct (Intermediate): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
• Communication (Intermediate): Clearly, effectively and respectfully communicates to employees or customers.
• Project Coordination (Intermediate): Performs project tracking and reporting relative to task completion dates, dependency effects, problem anticipation, schedule conflicts, and assignment to appropriate staff for resolution. Manages prioritization procedures for changing scope [i.e., change management] and project acceptance procedures. Measures progress toward goals and revises project objectives and documents applying change control procedures. Assumes responsibility [as appropriate] for resolving issues and seeing work through to successful completion. Provides training to project managers and others on project related templates and toolsets. Develops methods to measure customer satisfaction and obtains feedback at critical milestones and at project completion to ensure project efforts meet customer expectations.
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: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a "go-to" resource for colleagues with less experience; may lead small project teams.
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 :
3 years
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.
Clinical Research Coordinator
Clinical Research Coordinator Job 65 miles from Johnson City
Come work with a growing, multi-site clinical research team! CLINICAL RESEARCH COORDINATOR PURPOSE 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. RESPONSIBILITIES Work directly as the patient/subject interface at research sites to deliver high-quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
Assist with screening and enrollment of subjects into assigned studies.
Exhibit excellent customer service skills with trial subjects to encourage retention and future recruitment.
Assist with the establishment of a recruitment and contingency plan for each study.
Perform functions necessary for successful completion of all required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local county requirements.
Complete source documents and case report forms accurately in both paper and electronic format.
Assist investigator with recording and reporting of adverse events and SAEs per local regulatory authority guidelines.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND 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 written English language.
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.
MINIMUM REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATIONS
Bachelor's Degree or equivalent experience
Minimum of 3 years in clinical research
Current CPR certification - can be provided upon hire
International Air Transport Association (IATA) Certification - can be provided upon hire
Good Clinical Practice (GCP) - can be provided upon hire
Job Type: Full-time Benefits:
Paid time off
Flexible schedule
Advancement opportunities
401(k) with company match
Health, dental, and vision insurance
HSA with company match
Life and disability coverage
Employee referral program
Referral program
Schedule:
Day shift
Monday to Friday
Work Location: Onsite at 120 Hospital Dr, Suite 260, Jefferson City, TN 37760
Lead Clinical Research Coordinator-Memphis, TN
Clinical Research Coordinator Job 440 miles from Johnson City
What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Lead CRC is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Lead CRC is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials. The Lead CRC will also carry a full study load.
What You'll Be Working On
Duties include but not limited to:
Site Support Responsibilities:
Primary point of contact for the site
Supports Key Sponsors and CROs
Manages some of the sites most challenging therapeutic areas and study designs
Able to monitor and mentor all levels of CRCs to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
Assist Region Manager and Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits
Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager
Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
Study Preparation:
• Ability to understand and follow institutional SOPs
• Collaborate with PI to review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
• Work closely with Central Teams to ensure that all training and study requirements are met prior to trial conduct
• Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
• Assist with planning and creation of appropriate recruitment materials
• Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database
• Actively work with the recruitment team in calling and recruiting subjects
• Attend Investigator meetings.
• Coordinate and attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives and report summary to the Region Manager if they are not in attendance
• Assist in the creation or review of sponsor-provided protocol specific source documents
• Determine facility, equipment and outsource vendor requirements and availability
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)
• Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
• Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
• Work with Region Manager to identify and communicate staff needs
• Ensure there are adequate supplies and equipment on site
Study Management:
• Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines
• Maintain organized files for blank source documents, patient charts, CRFs, and supplies
• Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document accountability log and patient records. Temperature monitoring and compliance of IP storage conditions.
• Collect and evaluate concomitant medication
• Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the Care Access team in an ongoing fashion
• Maintain effective relationships with study participants and other Care Access personnel
• Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management
• Communicate clearly verbally and in writing
• Accept accountability for actions and function independently
Study Visit Conduct:
• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling a screening appointment
• Collect and review medical records against study Inclusion/Exclusion criteria
• Obtain informed consent per Care Access SOP
• Complete delegated visit procedures and ensure proper specimen collection, processing, and shipment in accordance with the protocol
• Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values ensuring investigator review in a timely fashion
• Record adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and Regulatory team following all applicable guidelines
• Schedule participants within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedules to maximize efficient workflow and positive participant experience
Documentation:
• ALCOA-C: Record data legibly, in real-time on source documents; note additional information that may assist with the causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
• Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion
• Accurately transcribe data to eCRF. Resolve data management queries and correct source data timely
• Enter all Quality issues into QMS and report protocol deviations to sponsor
• Work closely with Regulatory Team to ensure all documents are uploaded into eReg system
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Physical and Travel Requirements
· This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.
· Ability to work evenings and weekends as needed
· Must have access to reliable transportation
What You Bring
Knowledge, Skills, and Abilities:
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability and willingness to mentor and train site staff
Ability to communicate and work effectively with a diverse team of professionals
Excellent organization, prioritization, and leadership skills with strong attention to detail
Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
Critical thinker and problem solver
Excellent interpersonal skills, detail-oriented and meticulous
Friendly, outgoing personality with the ability to 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 and as a team player working together towards common goals
Certifications/Licenses, Education, and Experience:
- Bachelor's Degree or equivalent professional experience
-Research Professional Certification preferred
-A minimum of 5 years of Clinical Research Coordinator experience
Benefits (US Full-Time Employees Only)
● PTO/vacation days, sick days, holidays.
● 100% paid medical, dental, and vision Insurance. 75% for dependents.
● HSA plan
● Short-term disability, long-term disability, and life Insurance.
● Culture of growth and equality
● 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Clinical Research Coordinator III - Structural Heart IDE Research
Clinical Research Coordinator Job 248 miles from Johnson City
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:
Cardiovascular Med Admin 10
Job Summary:
With guidance and training, this position will act as the senior level research coordinator for the Heart Valve Research Team at VUMC. With assistance from the research manager, this role will be expected to provide day-to-day support and guidance for a team of 4-5 research coordinators overseeing investigational device heart valve trials. This individual will serve as a resource for the research coordinator team and assist in processing requests from Sponsors, the IRB, Health IT, Investigators, and research/clinical team, as well as other research related entities. They will act as a back-up for consenting/enrollment, procedural planning/oversight, and follow-up visits as well as assure that the processes, integrity and quality of the research are assessed and organized in conduct with our teams' systems. This candidate will be responsible for maintenance and submission of IRB documents from 10 - 11 Sponsor studies, cross-checking complex participant billing for compliance and accuracy as well as keeping regulatory documents organized, filed, and communicated to the lead coordinator of each trial.
WHO WE ARE LOOKING FOR:
We are looking for a dedicated individual with a passion for learning and contributing to groundbreaking heart valve research alongside a dynamic, fun, and interdisciplinary heart valve research team, including interventional cardiologist, surgeons, echocardiologist, radiologists, and nurses. This role may require a learning curve for most applicants, but someone that is teachable, willing to learn and eager to grow, and has a foundation of medical knowledge/anatomy would be a good fit.
While this position has the potential to work remotely some days of the week, we are looking for someone that will make themselves available in-person when needed to assist with and oversee exciting procedures with our cath lab team and lend a helping hand to coordinators in valve clinic at times.
Lastly, we are looking for someone that would be interested in growing with our team into a managerial role once acclimated and familiar with day-to-day processes.
Department Summary:
The Division of Cardiovascular Medicine at Vanderbilt University Medical Center (VUMC) is committed to understanding, preventing, and treating cardiovascular disease through: groundbreaking research, providing exceptional patient care, and training the next generation of leaders in cardiovascular medicine.
• Groundbreaking research
• Providing exceptional patient care
.
KEY RESPONSIBILITIES
Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, budgets, and D&H accounts.
Ability to oversee large and consistently evolving databases. This may include data entry, checking/running queries for completeness/accuracy as well as ensuring Federal and VUMC policies are being followed.
Meticulous and detail oriented with the ability to organize/file documents consistently and in a way that colleagues/study teams can identify. This includes maintaining original source documentation, utilizing systematic processes, and timely filing/data entry with awareness of good documentation practices.
Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process.
Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures.
Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. Problem solves when needed
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. Participates in data quality assurance reviews
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner
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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools
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: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a "go-to" resource for colleagues with less experience; may lead small project teams.
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 :
3 years
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.
Coordinator of Dual Studies
Clinical Research Coordinator Job 126 miles from Johnson City
Title: Coordinator Dual Studies Employee Classification: Other Professionals Institution: Roane State Community College Department: Dual Studies The Coordinator of Dual Studies assists the Director of Dual Studies to maintain and grow secondary to postsecondary initiatives, serve as a liaison between the College, Local Education Agencies, and high school administrators/students in the expanded Roane State service area.
Job Duties
* Acts as a liaison as needed with high school counselors to increase communication regarding general Roane State policies that directly affect current and potential Dual Studies students.
* Assists with advising students about the availability and utilization of the Dual Enrollment Grant (DEG) and how the use of the grant can affect future financial resources.
* Interacts with the appropriate faculty and staff to ensure that high school teachers have correct rosters, submit proper syllabi, and post grades in a timely fashion.
* Communicates with the Admissions, Site Directors, and Business Offices to ensure that Dual Studies students are enrolled, fees adjusted, etc.
* Offers guidance and assistance to dual studies students, parents, and faculty as necessary.
* Promotes Dual Studies program via in-person presentations, promotions, and communications with school personnel, students, parents, and communities.
* Attends conferences, seminars, and training sessions to enhance scope of the Dual Studies program.
* Completes associated reporting and paperwork and keeps Director of Dual Studies apprised of status.
Minimum Qualifications
* Bachelor's degree required
* Willing to travel to high schools where Dual Studies is offered
* Proficient in use of computer and Microsoft Office Suite
Knowledge, Skills, and Abilities
* Excellent organizational skills
* Excellent customer service skills