Clinical Research Associate II
Clinical research associate job in Arkansas
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Trials Coordinator
Clinical research associate job in Little Rock, AR
Job Description
Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.
This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.
Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.
About the position: As the Clinical Trials Coordinator is an entry-level role that supports a team of coordinators and technical staff in delivering renal pathology services for clinical trials. Reporting directly to the Clinical Trials Specialist Lead, this position is vital to the daily operations of the Clinical Trials Department and works collaboratively across all Arkana departments.
Key responsibilities include:
Ensuring accurate chain-of-custody for samples
Accessioning and processing samples
Slide scanning and document management
Performing other tasks as assigned by the department lead to ensure seamless departmental function
This role offers a pathway to a career in histopathology and/or client services, encouraging growth into specialized technical, client-facing, or leadership roles. The selected candidate will play a critical part in the team's success and is expected to attain Good Clinical Laboratory Practice (GCLP) certification.
What you'll do:
Collaborate with the CT Specialist Lead to support the Department in daily operations
Receive and accession Clinical Trials' samples using specialized software
Conduct archiving duties including scanning documents
Participate in the management of a de-identified clinical trials digital archive
Assist in the creation of forms (e.g. trial-specific scoring forms and related documentation)
Follow trial-specific instructions to assist with the upload of time-sensitive materials
Ensure delivery of samples within departments at Arkana
Deliver slides to specific departments or pathologists as needed
Assist other Clinical Trials Coordinators with all duties related to daily clinical trials operations
Complete subject tracking and document management
Assist with the return materials to clinical trials sponsors
Provide administrative support as needed to maintain daily operations within the Clinical Trials Department
Other duties as assigned
You should have:
Education: Associate or bachelor's degree
Experience: No experience is required. Candidates with work experience and up to three (3) positive references will receive preference
Computer Skills: Proficient in Microsoft Office and ability to gain proficiency in specialized inventory management software. Ability to read, write, and speak English is required. Ability to develop proficiency in medical terminology is required
Schedule: Monday-Friday 8am-5pm, onsite at the main office in Little Rock, AR.
This is an onsite position at our main office in Little Rock, Arkansas, applicants must live within 1 hour drive of the main office in Little Rock.
What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.
Specifically, we offer the following benefits to full-time employees:
Competitive salary
Generous paid time off and Paid Holidays
Minimal cost health insurance for you and affordable options for your family
401(k) with immediate eligibility and match
Company-paid life insurance
Company-paid long term disability coverage
Affordable vision and dental plans
Flexible Spending Account or Health Savings Account availability
Wellness plan and complimentary yoga classes
Monthly in-office massages and employer-sponsored lunches
Please see Careers for further information.
Feasibility Study Manager
Clinical research associate job in Little Rock, AR
**PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager** to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible.
**Key Responsibilities**
**Survey Design & Configuration**
+ Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting.
+ Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications.
+ Build survey reporting templates directly within the platform or through external systems as needed.
**Site & Investigator Readiness**
+ Perform quality checks on potential investigators before survey deployment.
+ Support verification of available CDAs prior to launch.
+ Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness.
**Survey Management & Execution**
+ Lead survey launch activities and oversee ongoing monitoring, including:
+ Delegating surveys appropriately
+ Tracking and reconciling survey status
+ Ensuring thorough documentation of site notes and survey details
+ Identifying and consolidating invalid contact information
+ Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking.
+ Monitor country‑level response metrics to support early risk identification and mitigation planning.
**Site Identification Strategy**
+ Execute the agreed site‑identification strategy, including application of priority site designations.
+ Implement the communication plan using approved study summaries, templates, and designated system email origins.
+ Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration.
+ Track CDA negotiation status for participating sites and communicate internal updates.
**Close‑Out Activities**
+ Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks.
**Minimum Qualifications**
+ **Education:** Bachelor's degree or equivalent.
+ **Experience:** 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas).
\#LI-KW1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Research Project Coordinator
Clinical research associate job in Little Rock, AR
This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research
departments.
**Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings**
We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington**
**Essential Functions**
+ **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources.
+ **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed.
+ **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing.
+ **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements.
+ **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices.
+ **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator.
+ **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review.
+ **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations.
**Skills**
+ Budgeting
+ Financial negotiation
+ Attention to detail
+ Multitasking
+ Clear written and verbal communication
+ Task Prioritization
+ Process Improvement
+ Critical thinking
+ Collaboration
+ Research
**Physical Requirements**
+ Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.
+ Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.
+ Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands.
+ Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
+ Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.
+ For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.
**Physical Requirements:**
**Minimum Qualifications**
+ Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
+ Demonstrated experience working in a collaborative team environment.
+ Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
+ Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.
+ Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
+ Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
**OR**
+ Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
**Preferred Qualifications**
+ Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting.
**Location:**
Intermountain Health Intermountain Medical Center
**Work City:**
Murray
**Work State:**
Utah
**Scheduled Weekly Hours:**
40
The hourly range for this position is listed below. Actual hourly rate dependent upon experience.
$27.65 - $43.55
We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
Learn more about our comprehensive benefits package here (***************************************************** .
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process.
All positions subject to close without notice.
Clinical Research Program Manager (Salaried, Full time)
Clinical research associate job in Fayetteville, AR
Organization Overview, Mission, Vision, and Values Our mission is to improve the health of people in the communities we serve through compassionate, high-quality care, prevention, and wellness education. Washington Regional Medical System is a community-owned, locally governed, non-profit health care system located in Northwest Arkansas in the heart of Fayetteville, which is consistently ranked among the Best Places to live in the country. Our 425-bed medical center has been named the #1 hospital in Arkansas for five consecutive years by U.S. News & World Report. We employ 3,400+ team members and serve the region with over 40 clinic locations, the region's only Level II trauma center, and five Centers of Excellence - the Washington Regional J.B. Hunt Transport Services Neuroscience Institute; Washington Regional Walker Heart Institute; Washington Regional Women and Infants Center; Washington Regional Total Joint Center; and Washington Regional Pat Walker Center for Seniors.
Position Summary
The role of the Clinical Research Program Manager reports to the Chief Medical Officer (CMO). This position is responsible for the day-to-day management and execution of clinical trials, ensuring adherence to protocols, regulations, and ethical guidelines. This position is responsible for participant recruitment, data collection, documentation management, and overall clinical study coordination. This position plays a vital role in monitoring participant safety and well-being.
Essential Position Responsibilities
* Manage research projects, including protocol implementation, data collection, and ensuring adherence to regulations and ethical guidelines.
* Ensure all study activities are conducted in accordance with approved protocols and relevant regulations, including Institutional Review Board (IRB) requirements and HIPAA.
* Recruit, enroll, and manage study participants, ensuring informed consent is obtained and safety is prioritized.
* Collect, compile, document, and verify accurate and complete data from participants, including case report forms, adverse event reports, and other study documentation and report progress on an ongoing basis.
* Work collaboratively with researchers, clinicians, and other team members to facilitate research activities.
* Assist with technical aspects of research, such as data entry, database management, and specimen collection.
* Conduct literature searches, assist with grant applications, and contribute to the development of research publications.
* Remain knowledgeable and up to date on the latest research methodologies and guidelines.
* Serve as a primary point of contact for study participants, researchers, and other stakeholders, ensuring clear communication and coordination.
Qualifications
* Education: Bachelor's degree in a related field, including biology, health sciences, or nursing, required. Master's degree in related field, preferred.
* Licensure and Certifications: Certified Clinical Research Coordinator (CCRC)
* Experience: Previous experience in a clinical setting, preferred. Previous experience in data mining and reporting within EMR, specifically Epic, preferred.
Professional Skills
* Strong organizational and time management skills.
* Excellent communication and interpersonal skills.
* Proficient in data entry, database management, and statistical software.
* Ability to work independently and as part of a team.
* Knowledge of research protocols, regulations, and GCP guidelines.
* Understanding of ethical research principles and participant safety.
Work Environment: This position will spend 40% of time standing or walking while performing work in an acute health care setting, including patient rooms. This position will spend 60% of time sitting while completing administrative job duties. This position will occasionally push, pull, lift or carry up to 50 lbs. This position will serve a culturally and linguistically diverse patient population. This position may be exposed to communicable diseases and bodily fluids.
Notice: This is designed to provide an overview of the essential and principal duties and responsibilities of the position. The job description is not designed or intended to cover or set forth a comprehensive listing of all activities, duties or responsibilities that are required of the employee. Washington Regional reserves the right in its absolute discretion to change duties, responsibilities or activities or assign new duties, responsibilities, or activities at any time with or without notice. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Clinical Trials Coordinator
Clinical research associate job in Little Rock, AR
Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.
This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.
Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.
About the position: As the Clinical Trials Coordinator is an entry-level role that supports a team of coordinators and technical staff in delivering renal pathology services for clinical trials. Reporting directly to the Clinical Trials Specialist Lead, this position is vital to the daily operations of the Clinical Trials Department and works collaboratively across all Arkana departments.
Key responsibilities include:
Ensuring accurate chain-of-custody for samples
Accessioning and processing samples
Slide scanning and document management
Performing other tasks as assigned by the department lead to ensure seamless departmental function
This role offers a pathway to a career in histopathology and/or client services, encouraging growth into specialized technical, client-facing, or leadership roles. The selected candidate will play a critical part in the team's success and is expected to attain Good Clinical Laboratory Practice (GCLP) certification.
What you'll do:
Collaborate with the CT Specialist Lead to support the Department in daily operations
Receive and accession Clinical Trials' samples using specialized software
Conduct archiving duties including scanning documents
Participate in the management of a de-identified clinical trials digital archive
Assist in the creation of forms (e.g. trial-specific scoring forms and related documentation)
Follow trial-specific instructions to assist with the upload of time-sensitive materials
Ensure delivery of samples within departments at Arkana
Deliver slides to specific departments or pathologists as needed
Assist other Clinical Trials Coordinators with all duties related to daily clinical trials operations
Complete subject tracking and document management
Assist with the return materials to clinical trials sponsors
Provide administrative support as needed to maintain daily operations within the Clinical Trials Department
Other duties as assigned
You should have:
Education: Associate or bachelor's degree
Experience: No experience is required. Candidates with work experience and up to three (3) positive references will receive preference
Computer Skills: Proficient in Microsoft Office and ability to gain proficiency in specialized inventory management software. Ability to read, write, and speak English is required. Ability to develop proficiency in medical terminology is required
Schedule: Monday-Friday 8am-5pm, onsite at the main office in Little Rock, AR.
This is an onsite position at our main office in Little Rock, Arkansas, applicants must live within 1 hour drive of the main office in Little Rock.
What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.
Specifically, we offer the following benefits to full-time employees:
Competitive salary
Generous paid time off and Paid Holidays
Minimal cost health insurance for you and affordable options for your family
401(k) with immediate eligibility and match
Company-paid life insurance
Company-paid long term disability coverage
Affordable vision and dental plans
Flexible Spending Account or Health Savings Account availability
Wellness plan and complimentary yoga classes
Monthly in-office massages and employer-sponsored lunches
Please see Careers for further information.
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research associate job in Little Rock, AR
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Senior Clinical Trial Monitor (Kentucky)
Clinical research associate job in Benton, AR
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
The Senior Clinical Trial Monitor is responsible for overseeing clinical trials, ensuring that they are conducted, recorded, and reported in compliance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The role acts as a point of contact at the site level for both internal and external stakeholders.
This position will reside in Kentucky.
Position Responsibilities:
* Identify new potential investigators and assess their sites for clinical trial capabilities.
* Build relationships with sites, including management of Contract Research Organizations (CROs).
* Recommend sites during feasibility and selection processes.
* Conduct pre-study and initiation visits to train site personnel.
* Monitor site activities through visits, ensuring adherence to protocols and regulations.
* Serve as an unblinded site monitor to protect study integrity.
* Use data to assess risks, identify issues, and make informed decisions.
* Provide training to site staff and manage site closure activities.
* Oversee site personnel to meet study objectives, including enrollment and retention goals.
* Address and escalate issues, ensuring corrective actions are implemented.
* Prepare and submit reports and support regulatory audits and inspections as needed.
Senior Level Expectations:
* Proactively identify and resolve issues at both site and country levels.
* Collaborate with Clinical Trial Managers to address complex issues.
* Serve as a mentor and coach, providing guidance and training to team members.
* May be assigned as a Lead Clinical Trial Monitor for a study locally.
Degree Requirements:
* Bachelor's degree, preferably in life sciences or equivalent.
* Valid driver's license (as required).
Experience Requirements:
* Minimum of 5 years of experience in clinical research or related fields.
* Candidates must be located in Kentucky.
Key Competencies:
* Knowledge of ICH/GCP guidelines and local regulations.
* Strong clinical research understanding.
* Excellent organization, time management, and communication skills.
* Proficiency in Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC), and Electronic Trial Master File (eTMF).
Travel Requirements:
* Travel up to 30%, depending on workload and region needs, may include air travel and overnight stays.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Senior Clinical Research Associate - West Coast - Oncology - FSP
Clinical research associate job in Little Rock, AR
The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel.
A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.
**Key Accountabilities:**
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desirable):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as required.
+ Valid driving license per country requirements, as applicable
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\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Dialysis Coordinator,(RN)
Clinical research associate job in Hot Springs, AR
Schedule: Full-time, Days
At National Park Medical Center, we are driven by a profound commitment to prioritize your well-being so you can provide exceptional care to others. Here, you're not just valued as an employee, but as a person. As a registered nurse (RN) joining our team, you're embracing a vital mission dedicated to
making communities healthier
. Join us on this meaningful journey where your skills, compassion, and dedication will make a remarkable difference in the lives of those we serve.
Position Summary
A Clinical Coordinator assists with the daily coordination of personnel and resources within the scope of assignment. Acts as the liaison between the nursing departments and all of the ancillary departments to promote continuity of care, optimal patient outcomes, patient satisfaction, cost efficiency and compliance.
Key Responsibilities:
Patient Assessment: Evaluate patients' medical conditions, support systems, and financial resources to determine appropriate care plans.
Care Coordination: Collaborate with physicians, therapists, and nursing staff to ensure patients receive necessary treatments and interventions.
Discharge Planning: Develop and implement discharge plans, arranging for follow-up care, home health services, or rehabilitation as needed.
Utilization Review: Monitor the appropriateness of hospital admissions and continued stays, ensuring compliance with healthcare regulations and optimizing resource utilization.
Patient Advocacy and Education: Advocate for patients' needs, provide education on treatment options, and support informed decision-making.
Skills and Qualifications:
Clinical Expertise: Strong foundation in nursing practices and patient care.
Communication Skills: Effective communication with patients, families, and healthcare professionals.
Critical Thinking: Ability to assess complex situations and develop appropriate care strategies.
Organizational Skills: Efficient management of multiple patients and coordination of diverse care aspects.
Certification: While not always required, obtaining certification such as the Accredited Case Manager (ACM) credential can demonstrate specialized knowledge in hospital case management.
How you'll contribute
You'll make an impact by utilizing your specialized plan-of-care intervention and serving as a patient-care innovator. You will shape exceptional patient journeys every day and leverage your skills and our cutting-edge technology to directly impact patient wellbeing.
What we offer
Fundamental to providing great care is supporting and rewarding our team. In addition to your base compensation, this position also offers*:
Shift differential
Comprehensive medical, dental, and vision plans, plus flexible-spending and health- savings accounts
Competitive paid time off
Income-protection programs, such as life, accident, critical-injury insurance, short- and long-term disability, and identity theft coverage
Tuition reimbursement, loan assistance, and 401(k) matching
Employee assistance program including mental, physical, and financial wellness
Professional development and growth opportunities
Qualifications and requirements
Applicants should have a current state RN license and possess a associates degree from an accredited nursing school. Additional requirements include:
Basic Life Support certification is required within 30 days of hire.
One year of experience preferred
ASLS certification preferred
About our Health System
National Park Medical Center is a 168 bed hospital located in Hot Springs, Arkansas, and is part of Lifepoint Health, a diversified healthcare delivery network committed to
making communities healthier
with acute care, rehabilitation, and behavioral health facilities from coast to coast. From your first day to your next career milestone-your experience matters.
EEOC Statement
National Park Medical Center is an Equal Opportunity Employer. National Park Medical Center is committed to Equal Employment Opportunity for all applicants and employees and complies with all applicable laws prohibiting discrimination and harassment in employment.”
Auto-ApplyClinical Dialysis Coordinator,(RN)
Clinical research associate job in Hot Springs, AR
Schedule: Full-time, Days At National Park Medical Center, we are driven by a profound commitment to prioritize your well-being so you can provide exceptional care to others. Here, you're not just valued as an employee, but as a person. As a registered nurse (RN) joining our team, you're embracing a vital mission dedicated to making communities healthier. Join us on this meaningful journey where your skills, compassion, and dedication will make a remarkable difference in the lives of those we serve.
Position Summary
A Clinical Coordinator assists with the daily coordination of personnel and resources within the scope of assignment. Acts as the liaison between the nursing departments and all of the ancillary departments to promote continuity of care, optimal patient outcomes, patient satisfaction, cost efficiency and compliance.
Key Responsibilities:
* Patient Assessment: Evaluate patients' medical conditions, support systems, and financial resources to determine appropriate care plans.
* Care Coordination: Collaborate with physicians, therapists, and nursing staff to ensure patients receive necessary treatments and interventions.
* Discharge Planning: Develop and implement discharge plans, arranging for follow-up care, home health services, or rehabilitation as needed.
* Utilization Review: Monitor the appropriateness of hospital admissions and continued stays, ensuring compliance with healthcare regulations and optimizing resource utilization.
* Patient Advocacy and Education: Advocate for patients' needs, provide education on treatment options, and support informed decision-making.
Skills and Qualifications:
* Clinical Expertise: Strong foundation in nursing practices and patient care.
* Communication Skills: Effective communication with patients, families, and healthcare professionals.
* Critical Thinking: Ability to assess complex situations and develop appropriate care strategies.
* Organizational Skills: Efficient management of multiple patients and coordination of diverse care aspects.
* Certification: While not always required, obtaining certification such as the Accredited Case Manager (ACM) credential can demonstrate specialized knowledge in hospital case management.
How you'll contribute
You'll make an impact by utilizing your specialized plan-of-care intervention and serving as a patient-care innovator. You will shape exceptional patient journeys every day and leverage your skills and our cutting-edge technology to directly impact patient wellbeing.
What we offer
Fundamental to providing great care is supporting and rewarding our team. In addition to your base compensation, this position also offers*:
* Shift differential
* Comprehensive medical, dental, and vision plans, plus flexible-spending and health- savings accounts
* Competitive paid time off
* Income-protection programs, such as life, accident, critical-injury insurance, short- and long-term disability, and identity theft coverage
* Tuition reimbursement, loan assistance, and 401(k) matching
* Employee assistance program including mental, physical, and financial wellness
* Professional development and growth opportunities
Qualifications and requirements
Applicants should have a current state RN license and possess a associates degree from an accredited nursing school. Additional requirements include:
* Basic Life Support certification is required within 30 days of hire.
* One year of experience preferred
* ASLS certification preferred
About our Health System
National Park Medical Center is a 168 bed hospital located in Hot Springs, Arkansas, and is part of Lifepoint Health, a diversified healthcare delivery network committed to making communities healthier with acute care, rehabilitation, and behavioral health facilities from coast to coast. From your first day to your next career milestone-your experience matters.
EEOC Statement
National Park Medical Center is an Equal Opportunity Employer. National Park Medical Center is committed to Equal Employment Opportunity for all applicants and employees and complies with all applicable laws prohibiting discrimination and harassment in employment."
Trial Master File (TMF) Specialist Oncology
Clinical research associate job in Little Rock, AR
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Sr. Clinical Research Associate - Oncology - TX or CO - FSP
Clinical research associate job in Little Rock, AR
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#LI-LO1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Faculty/Clinical Coordinator
Clinical research associate job in Arkansas
Current University of Arkansas System employees including student employees and graduate assistants need to log into Workday on My Apps. Simply enter "Find Jobs" in the Workday search bar to view open positions. All Job Postings will close at 12:01 a.m. CT on the specified Closing Date (if designated). To view the job posting closing date please return to the search for jobs page.
If you close the browser or exit your application prior to submitting, the application process will be saved as a draft. You will be able to access and complete the application through “My Draft Applications” located on your Candidate Home page.
Type of Position:Faculty - Non-Tenure
Workstudy Position:
No
Job Type:Regular
Work Shift:
Sponsorship Available:
No
Institution Name: University of Arkansas Pulaski Technical College
University of Arkansas - Pulaski Technical College at North Little Rock is an integral part of the Arkansas Technical and Community College System maintained by the State of Arkansas. The college is governed by the University of Arkansas System Board of Trustees and a seven-member Board of Visitors and derives its support largely from student tuition and fees and legislative appropriations.
UA - Pulaski Tech, a comprehensive two-year college, offers associate degree and certificate programs for students who plan to transfer to four-year colleges and universities and/or for career preparation and advancement. Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply link/button.
For general application assistance or if you have questions about a job posting, please contact Human Resources at **************.
Department:Surgical Technology
Department's Website:
Summary of Job Duties:Position Summary: The Surgical Technology Faculty/Clinical Coordinator responsible for instruction of students in the program where applicable in accordance with established policies, procedures and established ARCSTA guidelines. The position reports directly to the Program Director. Must have current certification or licensure. Will collaborate with the Clinical Managers, the Schedule Coordinator and/or the Educational Coordinator for the Operating Room. Will possess good interpersonal skills in relating to students, clinical personnel and physicians.
Qualifications:
Minimum:
Bachelor's Degree required
Current credential in surgical technology (CST)
Must be capable of teaching both the clinical and didactic aspects of the program
Post-secondary education experience desired
Must also meet all regulatory and corporate qualifications
Must have the knowledge and ability to judge student competence
Requires strong attention to details and a positive professional attitude
Must have a minimum of 4 years of clinical experience as a Surgical Technologist
Preferred:
Master's Degree preferred
Teaching experience preferred
Salary Information:
Required Documents to Apply:
Cover Letter/Letter of Application, License or Certificate (see special instructions for submission instructions), List of three Professional References (name, email, business title), Resume, Unofficial/Official Transcript(s)
Optional Documents:
Additional Information:
Recruitment Contact Information:
Whitney Shirley Administrative Assistant ************
All application materials must be uploaded to the University of Arkansas System Career Site *****************************************
Please do not send to listed recruitment contact.
Pre-employment Screening Requirements:
University of Arkansas - Pulaski Technical College is committed to providing a safe campus community. Title IX protects the college community from sexual harassment in a school's education programs and activities. This means that Title IX protects the college community in connection with all academic, educational, extracurricular, athletic, and other programs of the school, whether those programs take place in a school's facilities, in college transportation, at a class or training program sponsored by the school at another location, or elsewhere.
No person at the University of Arkansas - Pulaski Technical College will, on the basis of sex, be excluded from participation in, be denied benefit of, or be subjected to sex discrimination, sexual harassment, or sexual misconduct under any education program or activity.
We conduct background checks for applicants being considered for employment. Background checks include a criminal background check and a sex offender registry check. For certain positions, there may also be a financial (credit) background check, a Motor Vehicle Registry (MVR) check, and/or drug screening. Required checks are identified in the position listing. A criminal conviction or arrest pending adjudication or adverse financial history information alone shall not disqualify an applicant in the absence of a relationship to the requirements of the position. Background check information will be used in a confidential, non-discriminatory manner consistent with state and federal law.
Constant Physical Activity:
Frequent Physical Activity:
Occasional Physical Activity:
Benefits Eligible:Yes
Auto-ApplyClinical Trials Specialist
Clinical research associate job in Little Rock, AR
Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.
This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.
Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.
About the position: As the Clinical Trials Specialist, you will assist the Clinical Trials Specialist Lead and team performing tasks associated with carrying out clinical trials. Accompany the Clinical Trials team to trade shows. Assist the Lead and Clinical Trials Referral Coordinator with referral process plans. Serve as a liaison between Arkana and clinical trials clients to ensure service is delivered according to our promise. Work is performed in accordance with standard laboratory practice under limited supervision.
What you'll do:
Represent Arkana Clinical Trials Department at trade shows, institutes/clinics, independently and as needed
Assist the Lead with sponsor relations and development
Ongoing management of client relationship including leading weekly status meetings and responding to client inquiries
Sample accessioning
Maintain study-specific documents as per sponsor guidelines
Provide immediate oversight of clinical trial subject trackers for trials
Maintain regulatory compliance training (e.g. Good Clinical Laboratory Practice certification)
Other duties as assigned
You should have:
Education: Bachelor degree (B.A. or B.S.) with one to two years of related experience and/or training; or an equivalent combination of education and experience
Experience: At least three years of client service experience in a laboratory setting is preferred
Computer Skills: Proficient in Microsoft Office and ability to gain proficiency in electronic data capture systems used by Arkana
Schedule: Monday-Friday 8am-5pm. This position is onsite at our main office in Little Rock, Arkansas
What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.
Specifically, we offer the following benefits to full-time employees:
Competitive salary
Generous paid time off and Paid Holidays
Minimal cost health insurance for you and affordable options for your family
401(k) with immediate eligibility and match
Company-paid life insurance
Company-paid long term disability coverage
Affordable vision and dental plans
Flexible Spending Account or Health Savings Account availability
Wellness plan and complimentary yoga classes
Monthly in-office massages and employer-sponsored lunches
Please see Careers for further information.
Auto-ApplySr. Clinical Research Associate - FSP
Clinical research associate job in Little Rock, AR
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
LI-LG4
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Research Associate 1
Clinical research associate job in Nashville, AR
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, PTO and 401K
Clinical Trials Specialist
Clinical research associate job in Little Rock, AR
Job Description
Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.
This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.
Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.
About the position: As the Clinical Trials Specialist, you will assist the Clinical Trials Specialist Lead and team performing tasks associated with carrying out clinical trials. Accompany the Clinical Trials team to trade shows. Assist the Lead and Clinical Trials Referral Coordinator with referral process plans. Serve as a liaison between Arkana and clinical trials clients to ensure service is delivered according to our promise. Work is performed in accordance with standard laboratory practice under limited supervision.
What you'll do:
Represent Arkana Clinical Trials Department at trade shows, institutes/clinics, independently and as needed
Assist the Lead with sponsor relations and development
Ongoing management of client relationship including leading weekly status meetings and responding to client inquiries
Sample accessioning
Maintain study-specific documents as per sponsor guidelines
Provide immediate oversight of clinical trial subject trackers for trials
Maintain regulatory compliance training (e.g. Good Clinical Laboratory Practice certification)
Other duties as assigned
You should have:
Education: Bachelor degree (B.A. or B.S.) with one to two years of related experience and/or training; or an equivalent combination of education and experience
Experience: At least three years of client service experience in a laboratory setting is preferred
Computer Skills: Proficient in Microsoft Office and ability to gain proficiency in electronic data capture systems used by Arkana
Schedule: Monday-Friday 8am-5pm. This position is onsite at our main office in Little Rock, Arkansas
What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.
Specifically, we offer the following benefits to full-time employees:
Competitive salary
Generous paid time off and Paid Holidays
Minimal cost health insurance for you and affordable options for your family
401(k) with immediate eligibility and match
Company-paid life insurance
Company-paid long term disability coverage
Affordable vision and dental plans
Flexible Spending Account or Health Savings Account availability
Wellness plan and complimentary yoga classes
Monthly in-office massages and employer-sponsored lunches
Please see Careers for further information.
Clinical Research Associate 1
Clinical research associate job in Portland, AR
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, PTO and 401K