Study Manager
Clinical Research Coordinator Job 17 miles from Mesa
DRA Global Limited is an international multi-disciplinary engineering, project delivery and operations management group, predominantly focused on the mining, minerals, and metals industry.
The Group has an extensive track record spanning almost four decades across a wide range of commodities. Our teams have deep expertise in the mining, minerals, and metals processing industries, as well as related non-process infrastructure such as water, and energy solutions.
DRA covers all major mining centers with offices across Africa and the Middle East, North and South America, and the Asia-Pacific.
We are looking for a talented Study Manager for our Phoenix office with Mining Pre-Feasibility & Feasibility experience, strong leadership skills, and specific knowledge and experience with lithium, gold, copper and other precious metals.
The Study Manager will have overall management of the study, ensuring it is efficiently and effectively managed, resulting in a completed product that is to the Client's satisfaction.
Main functions include (but not limited to):
Support and participation in preparation of study proposals.
Overall management of the study scope, deliverables, schedule, budget and quality
Change management, progress & study reporting.
Management of the client relationship including preparation and presentation of study status to client executives and board of directors.
Key Responsibilities:
Lead the preparation & consolidation of NI 43-101 reports at three main study phases (PEA, PFS, FS) utilizing industry best practices.
Ensures that the study is managed such that the economic-technical solution offered is to the Client's requirements.
Work closely with client to evaluate multiple scenarios in the development of an economic business case.
Ensures that the engineering effort is well coordinated between disciplines and departments.
Management of the study scope including management of the change control process.
Management of the study budget and related study's cost control processes.
Management of project risks, such that risks to both the DRA and the Client are mitigated.
Management of the study close-out phase and ensuring that study lessons learned are documented, communicated, and distributed.
Ensures appropriate resources are deployed to ensure the studies success.
Ensures that a positive and constructive atmosphere is propagated through the study team.
Management of the commercial aspects of the study to ensure that the study is profitable, and consistent with the margins envisaged at tender stage.
Participates in staff performance, discipline and other management processes.
Requirements:
Degree in Engineering, from a recognized university.
With 10+ years of relevant experience in an EPCM, mining construction and/or operations.
Must have a minimum of 5 years as a Study Manager on large mining projects ($300+ Mn)
Knowledge of study/project execution, including all elements of project management and how to plan project activities for different project phases.
Demonstrated ability to develop new, proprietary and innovative solutions to current processes.
General mining industry project development experience and understanding of project development phases (PEA, PFS, FS) requirements.
Employment type:
Permanent
We value diversity and the benefits it brings to achieving our objectives, enhancing our reputation, and attracting, engaging, and retaining talented people. We welcome applications from all backgrounds regardless of gender, age, disability, and ethnicity.
Our commitment to equal opportunities and a diverse workplace is embodied in our values of People, Safety, Trust, Integrity, Excellence, and Courage.
Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
The Clinical Research Coordinator is responsible for the coordination and administration of clinical trials under the direction and supervision of the Principal Investigator.
● Carry out clinical trial activities by adhering to Good Clinical Practice and study protocols
● Maintain the integrity of data while protecting the rights, safety, and well-being of patients enrolled in clinical trials
● Perform phlebotomy, EKGs, and obtain vital signs
● Work closely with study monitors to coordinate and carry out Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits.
● Complete Feasibility Questionnaires with PI and reach out to pharmaceutical and device companies to participate in new studies
● Communicate with Institutional Review Boards to maintain the proper oversight of clinical trials
● Day-to-day oversight of the research team
● Ensure research staff remains on task throughout the work day
Maintain a professional environment
Delegation and prioritization of tasks
● Oversee recruitment of research studies in collaboration with the protocol specific CRCs and research assistants to ensure referrals are contacted within 24-hours and recruitment portals are maintained up-to-date
● Manage batch shipment schedule Monday-Thursday based off of clinic and staff schedules
● Work with protocol specific CRCs to ensure that binders are kept audit ready at all times
● Ensure temperature controlled areas are maintained at the proper temperature and that temperature readings are documented daily upon arrival to the site
● Ensure that Calibration Log is kept up-to-date
● Ensure that research staff is following Research Task List in downtime
● Manage the research calendar in accordance with Investigator schedules
● Work with protocol specific lead CRCs to ensure that data entry and queries are attended to within a timely manner and per Clinical Trial Agreement timelines
● Confirm that staff training is up-to-date at all times. Work with protocol specific CRCs to ensure that delegated staff trainings are up-to-date
**Please submit cover letter to be considered for this position.
Academic/Faculty/Research Nurse Practitioner
Clinical Research Coordinator Job 39 miles from Mesa
We are searching for a full time Adult-GerontologyNurse Practitioner in Surprise, AZ. The NP will be responsible for providinghigh-quality healthcare services to adult and older adult patients. This roleinvolves comprehensive patient assessment, diagnosis, treatment planning, andcollaboration with healthcare teams to ensure optimal patient outcomes.
Benefits: Medical,Vision, and Dental Insurance, Retirement Benefits, Paid Time Off, EmployeeRecognition Program and Employee Wellness Program.
Requirements:
Master's or Doctoral degree in Nursingwith a focus on Adult-Gerontology Nurse Practitioner.
Current Arizona state licensure as aNurse Practitioner.
Certification as an Adult-GerontologyNurse Practitioner.
Clinical experience in adult andgeriatric healthcare.
Responsibilities:
Patient Assessment and Diagnosis
Primary Care Services
Treatment Planning and Prescribing
Collaboration and Communication
Patient Education
Geriatric Specialization
Documentation
Community Outreach and Advocacy
Clinical Research Associate - Oncology - LA/PHX/SLC/Seattle (major hub city)
Clinical Research Coordinator Job 17 miles from Mesa
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What will you be doing?
Works on multiple trials within Oncology
Quality of life focus wtih Regional Travel
Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team
Acts as Lead SM-training other SMs on study
Develops site start up documents for studies including SIV agenda
Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
Represents LTMs or SMs on SMTs/meetings
Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
Supports country budget development and/or contract negotiation in liaison with CCS colleagues
Assists with ASV
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
Qualifications
What do you need to have?
Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in the West in a hub city like LA, Phoenix, Denver, Seattle, SLC near a major airport
Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring Oncology trials
Knowledge of several therapeutic areas
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
Need to travel up to 50%
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
Pay Range ($91,336.00 USD - $114,170.00USD)
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Lead Clinical Research Associate - Arizona
Clinical Research Coordinator Job 6 miles from Mesa
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) Team Lead, to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies. This person will need to live within a few hours of our Tempe, Arizona location.
Essential Functions
Team Leadership and Line Management
Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to:
•Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations.
•Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities.
•Prepare and implement function specific training programs; ensure training on and adherence to Celerion's procedures and guidance documents, best business practices, legal and confidentiality constraints.
•Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization.
•Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner.
•Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained.
•Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability
•Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management
•Advocate for the needs of the staff with other functions of the organization
•Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals
•Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner
•Contribute to Process Improvement initiatives for Line of Service (LOS)
Project related responsibilities
Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:
•Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:
-Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs
-Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.)
-Co-monitor as needed
-Update and review of clinical trial management tracking systems (CTMS)
-Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened)
-Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors
-Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan
•Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;
•Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues
•Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress
•Participate in audits and inspections, including preparation and follow-up activities as needed
•Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.
•May act as a CRA for selected studies where needed and defined
Additional Responsibilities
•Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client
•Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)
•Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities
•Maintain a working knowledge of all required Celerion IT systems
•Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary
•Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates
•Perform other duties as assigned
Requirements and Qualifications:
•Bachelor's degree in a biomedical-related field, life sciences or equivalent field;
•At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience
•People Management skills preferred;
•Excellent oral and written communication skills in English;
•High level of organization, multi-tasking, judgement , and analytical skills;
•Good time management skills to ensure adherence to timelines;
•Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements ;
•Dedication to quality and reliability;
•Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research;
•Ability to work well independently and as part of a team;
•Self-motivation;
•Maintain confidentiality of Subject data and Sponsor/Client information
•Computer literate;
•Strong attention to detail while being tactful and diplomatic.
•Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements;
•Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs;
•Flexible and willing to drive to the Tempe, Arizona site without much advanced notice.
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Clinical Research Associate II, Dermatology, (NV, OR, AZ)
Clinical Research Coordinator Job 17 miles from Mesa
Clinical Research Associate II, Dermatology & Rheumatology (Oregon, Nevada and/or Arizona)
The clinical research associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
This role will be perfect for you if:
You are an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
You have supported studies in dermatology and have experience in risk-based monitoring
Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
RESPONSIBILITIES
The clinical research associate (CRA):
Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations
Participates in investigators' meetings
Prepares site visit reports and follow-up letters to the investigator
Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
Education
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience
2-5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
Dermatology exposure
Knowledge and skills
Good knowledge of ICH/GCP standards and applicable regulatory requirements
Strong verbal and written communication skills in English
Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
Excellent judgement and problem-solving skills
Travel to research sites approximately 65% of the time
Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
Experience in dermatology is an asset
At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Clinical Research Associate, you will be eligible for the following perks:
Permanent full-time position
Benefits
401K
Ongoing learning and development
Work location
This position is home-based with local or regional travel required to clinical research sites
The employee is expected to maintain a suitable dedicated home office or work space and be located near a major travel hub
About Innovaderm
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in the United States.
Clinical Research Associate II
Clinical Research Coordinator Job 17 miles from Mesa
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Associate (East Coast - US Region)
Clinical Research Coordinator Job 17 miles from Mesa
Hello humankindness
Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.
We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's.
U.S News & World Report
routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.
St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of
Arizona's Most Admired Companies
.
Look for us on Facebook and follow us on Twitter.
For the health of our community ... we are proud to be a tobacco-free campus.
Responsibilities
Join BNI CRO as a Clinical Research Associate (CRA) and collaborate with dedicated research sites, contributing to rare neurological disease research. Make a significant impact in the scientific community alongside a dedicated team of CRAs. This remote position involves up to 75% travel across the US, primarily focusing on northeast and east coast regional site assignments. Your role will encompass important site monitoring and management activities, including SIVs, Interim, and Remote Monitoring Visits, as well as Final Onsite and Closeout Visits. Advance your career, and acquire valuable skills at Barrow Neurological Institute, all while contributing to groundbreaking clinical research!
This Clinical Research Associate will report directly to the BNI Clinical Research Organization (CRO) Program Manager. The CRA position will independently be responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator initiated, or industry sponsored clinical studies throughout the United States and Canada. The CRA will travel to assigned clinical research sites to conduct approx. 25-30 clinical trial monitoring visits each year, and will also complete remote/centralized monitoring visits to ensure clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guidelines, and all applicable regulatory requirements.
The CRA will be responsible for the timely reporting of all monitoring visit findings, and is expected to complete comprehensive monitoring reports and associated deliverables to provide back to the Sponsor and the clinical sites. Additionally, the CRA role will oversee clinical site training activities and, conduct remote webinar and onsite protocol training for Physician Site Investigators, Clinical Research Coordinators, Research Nurses, and other delegated healthcare study personnel. The CRA will be responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Dignity Health's travel and expense purchasing policy. The CRA role will actively participate in departmental quality control and program development activities as directed by the BNI CRO Program Manager.
Responsibilities Include:
Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership. Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada. During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines. The CRA is expected to work cooperatively with study team and operations management to proactively drive project success.
Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership.
Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership.
Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between BNI CRO and the Clinical Study Sponsor to ensure BNI CRO provides quality monitoring and site management customer services. The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members.
Qualifications
Minimum Required
2-3 years of clinical research experience required or a combination of equivalent experience and education.
Excellent written /oral communication, interpersonal, and organizational skills required.
Good presentation skills and ability to effectively communicate information and processes to a variety of audiences.
Ability to travel frequently on domestic and extended trips throughout the United States and Canada (up to 75% of the time), to perform clinical monitoring visits, primarily in the northeast/east coast region,
Proven attention to detail, excellent problem solving and customer service skills, and ability to multi-task.
Education
Bachelors Degree or equivalent combination of education and experience or its international equivalent in clinical, science, or health related field from an accredited institution required or a healthcare professional licensure such as a Registered Nurse or Physical Therapist.
Special Skills
Strong interpersonal skills to effectively navigate a matrix organizational structure and effectively lead cross functional teams.
Excellent communication skills (verbal and written) to effectively communicate complex information and processes to a variety of audiences.
Proven attention to detail, with strong analytical, critical thinking, problem solving, time management, and customer service skills.
Experience with Microsoft Office Suite Systems
Preferred:
Electronic Data Capture System (EDC) skills preferred
CCRA or CCRP certification preferred
Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
Our Clinical Research Coordinator is a specialized research professional working with and under the direction of the Principal Investigator (PI) and Clinical Research Manager. They are responsible for conducting and supporting the assessment, planning, implementation, and execution of research protocols. They also support and facilitate the daily clinical trial activities and take on a supportive role in the conduct of site studies.
Schedule: Onsite, Monday through Friday
What You'll Do:
Participates in initiation and maintenance of study protocols
Completes procedures throughout study visits including, but not limited to, collection of vitals and ECGs, phlebotomy, blood processing, collection of height and weight, conducting subject questionnaires, and other protocol specific items
Processes blood, urine, and biopsy samples in accordance with study protocols and IATA/OSHA standards.
Completes study source documentation, data entry into electronic data capture (EDC) systems, and maintenance of study files.
Completes study visits per study protocol, inclusive of source document and case report form completion and submission
Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
Ensures clinical trial files are documented in accordance with company standard operating procedures, study protocol, and Good Clinical Practice (GCP).
Pre-screens and screens potential research participants and clinical patients for enrollment and assists with implementing recruitment strategies.
Skills and Experience:
- Minimum of 1 year experience is required
- Knowledge of clinical research regulations and GCP guidelines
- Bilingual in Spanish is highly preferred
In support of our mission statement, "Healthier Practices, Healthier Patients", we have adopted a tobacco-free environment and we prefer NOT to hire tobacco and nicotine users, including the use of e-cigarettes/vaping.
Research Coordinator - Clinical-**Sign on Bonus Available**
Clinical Research Coordinator Job 9 miles from Mesa
Ironwood Cancer & Research Centers has beautiful state-of-the-art integrated Cancer and Women's Centers, with locations strategically located throughout the Valley. Each one provides a superior cancer care environment with a full spectrum of cancer related services for patients. Our multi-disciplinary team approach includes surgical oncology, medical oncology, radiation oncology, women's centers, diagnostic imaging services, integrative services including social work and nutrition, and genetic counseling.
Mission Statement: To serve the community by providing quality, comprehensive cancer care which respects the values and needs of each individual.
Overview: We are looking for a qualified and experienced Research Coordinator. Manages and coordinates all aspects of conducting clinical trials within Ironwood Physicians, PC facilities, both clinically and administrative/regulatory. Required to have in-depth knowledge of protocol requirements and ensures that studies are properly conducted in conformance with the protocol guidelines, departmental standards and good clinical practices as set forth by federal regulations and international guidelines. Schedule: Full-time, Monday through Friday day shift position and located in our Gilbert and Mesa.
Essential Duties and Responsibilities include:
Acts as liaison between investigators, other study staff, primary care providers, IRB and sponsor.
Reviews studies for clinical and operational feasibility, along with the Investigator and Director of Research.
Screens, consents, enrolls and follows study subjects ensuring protocol compliance and close monitoring while subjects are on study utilizing Research Nurses' oversight for help with clinical decision making.
Responsible for all data and source documentation, adverse experience reporting, and will assist Regulatory Specialist in the maintenance of complete regulatory files.
Develops screening/enrollment/follow up mechanisms.
Ensures that randomization procedures and blinding procedures, as applicable, are followed as per protocol guidelines.
Schedules and performs patient procedures, assessments, evaluations and testing as required by the protocol, including but not limited to blood sample collection, processing and shipping, ECG, vital signs, etc., as applicable.
Knowledge and Skills:
Excellent clinical and functional skills.
Organized and detail oriented.
Data entry experience a plus.
Proficiency in Microsoft Office, Word, Outlook, and Internet.
Ability to use office equipment, computer.
Proficiency in Microsoft Office, Word, Outlook, and Internet.
Education and Experience:
Associate or Bachelor's Degree.
Clinical experience in Oncology or other acute care.
Prior research and phlebotomy experience.
Current IATA, Human subjects protection training or GCP training highly desirable.
We offer a competitive salary and a comprehensive benefit package including health/dental/vision and life insurance, 401K, and a caring work environment. We are an E.O.E.
Please visit our website at ******************** "Outsmarting Cancer One Patient at a Time"
Clinical Research Coordinator II or III
Clinical Research Coordinator Job 9 miles from Mesa
About Us:
Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.
Job Summary:
Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II or III position in Chandler.
Title: Clinical Research Coordinator II or III
Compensation: Depending on experience
Status: Full-time, Non-exempt
Essential job functions/duties:
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.
Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.
Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
Develop management systems and prepare for study initiation
Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol
Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
Responsible for meeting recruitment goals for each study.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Serves as a liaison to all physicians, employees, and third-party vendors.
Record data and study documentation
Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate.
Assign patient stipend pay card at screening
Document reason for screen-fail in real time
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Record data as directed using the appropriate media or platform
Follow procedures for access and security for electronic data entry
Review keyed data for accuracy as needed
Send data to the data collection center on a timely basis
Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
Develop and/or edit source as needed independently or with Quality Assurance / Quality Control team to
Ensure compliance with protocol and EDC.
Correct and edit data as directed and as appropriate.
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Document and record all AEs and SAEs as outlined in protocol
Monitor and report adverse events
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Responsible for administrative duties including filing documents related to subject's participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Ensure W-9 and medical release forms are signed by subjects annually.
Management of site activities during audits and inspections
Management of ancillary staff as assigned
Train and supervise support staff (e.g., CRC I)
Mentor for externs
Train newly hired employees as either Research Assistant and/or CRC
Prepare for quality assurance audits and regulatory inspections as needed
Act as contact person before, during and after audits and inspections
Provide all required documentation to auditors
Make all appropriate corrections as requested by auditors
Coordinate site response to audit/inspection findings.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Other responsibilities as delegated by manager.
Knowledge/Skills/Abilities required:
Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials.
Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management).
A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
Interpersonal and communication skills-interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources.
Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility protocol deviations, serious adverse events and other reporting requirements.
Able to perform all Job duties listed for Job Description for Phlebotomist
Know and understand all regulatory requirements associated with the conduct of the study assigned.
Travel requirements:
Some interoffice travel may be required with use of company vehicle or mileage reimbursement
Education, credentials, and/or trainings required:
Associates or Bachelor's degree in healthcare, clinical research management, or related required.
Master's degree or study-specific training preferred
GCP certification required at hire.
Experience and training in the conduct of clinical research and basic knowledge of medical terminology.
Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)
Experience with data management and tracking software
Benefits & Perks:
Health, Dental, Vision (with HSA plans and employer contribution)
PTO
5 days Sick Time
401K with 6% company match
Short & Long Term Disability
CEUs / Educational Assistance
Shared company vehicles for required travel
Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.
EEO statement
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.
Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.
Unblinded Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
Unblinded Clinical Research Coordinator DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.
Duties & Responsibilities:
Compound and dispense prescribed IP.
Supervise and maintain records of all medications
Ensure compliance with study-specific blinding plans.
Provide consultative support regarding the preparation and dosing of drugs.
Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.
Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials.
Understand and apply all applicable site procedures.
Ensure receipt and proper storage of IP and bioretention samples.
Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.
Review protocols and provide input on clinical and pharmacy supply needs.
Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information.
Temperature reporting.
Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Foreign Medical Graduate is a plus
Pharmacy Technician Certification a plus
Experience:
Clinical Experience
Credentials:
LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant)
Knowledge and Skills:
Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Excellent communication and customer service skills.
Outgoing personality Well-organized with attention to detail.
Must be able to multitask.
Bilingual (Spanish) preferred but not required
Study Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
We are seeking a dedicated Study Coordinator to conduct human subject research. Participants will use various technology products, and you will monitor and collect data throughout the sessions. Each session lasts up to 2.5 hours, where you will work directly with participants to support data collection.
Responsibilities
* Conduct human subject research according to protocol.
* Obtain consent from participants and take necessary vitals and measurements (height, weight, EKG) at the beginning and throughout the session.
* Ensure participants are properly set up with devices and monitoring equipment.
* Observe participants using devices during various activities as per protocol.
* Ensure data monitoring is functioning properly throughout the session.
* Collect data accurately and guide participants throughout the study.
Essential Skills
* Background in science (Bachelor's Degree in science, exercise science, kinesiology, biology).
* Ability to execute test protocols.
* Technical proficiency to operate test devices and perform data entry.
* Capability to direct participants through the study.
* Familiarity with gym equipment and clinical research.
Additional Skills & Qualifications
* Experience in human subject research.
* Data analysis skills.
Work Environment
The work environment includes morning and afternoon shifts, with AM shifts starting as early as 7:30 AM to 2:00 PM and PM shifts from 2:00 PM to 9:00 PM. Shifts typically last 6 hours each. You will be on your feet for long periods, with some desk work, working with participants in a simulated environment. There are 4 openings for the day shift and 2 openings for the evening shift. This role offers flexibility in shifts to accommodate school schedules, making it an ideal opportunity for graduate students.
Pay and Benefits
The pay range for this position is $25.00 - $25.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Phoenix,AZ.
Application Deadline
This position is anticipated to close on Mar 14, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
Under the direction of the Manager, the Clinical Research Coordinator, I analyze and evaluate clinical data. Ensures compliance with protocol and overall clinical objectives. Relies on instructions and pre-established guidelines to perform the functions of the job. # Annual Salary Range: $46,155.20 - $68,078.40# # Qualifications Education: Requires a bachelor#s degree, preferably in biological sciences or related medical/scientific field, or an equivalent combination of training and progressively responsible experience that will result in the required specialized knowledge and abilities to perform the assigned work. A master#s degree is preferred and may substitute for the required experience. Experience: Must have at least two (2) years or more of related healthcare experience, preferably in a large healthcare system, or prior clinical research experience. Lab experience preferred. Specialized Training: Must have Human Subjects Protection Training or be able to obtain within 14 days of hire. Certification/Licensure: Must possess a current valid Arizona driver#s license. Prefer SoCRA certification as Certified Clinical Research Professional, or an ACRP/APCR certification as a CRA, CRC, or PI. Requires a BLS card obtained through an approved American Heart Association (AHA) training center within 3 months. Knowledge, Skills, and Abilities: Must have excellent communication (oral and written) and presentation skills. Must be proficient in medical terminology. Must have strong computer skills in Microsoft Office applications. Requires excellent project management skills and interpersonal communication abilities. Must have the ability to rotate being on-call and the ability to travel. Requires the ability to read, write, and speak effectively in English. Bilingual is a plus.
Under the direction of the Manager, the Clinical Research Coordinator, I analyze and evaluate clinical data. Ensures compliance with protocol and overall clinical objectives. Relies on instructions and pre-established guidelines to perform the functions of the job.
Annual Salary Range: $46,155.20 - $68,078.40
Qualifications
Education:
* Requires a bachelor's degree, preferably in biological sciences or related medical/scientific field, or an equivalent combination of training and progressively responsible experience that will result in the required specialized knowledge and abilities to perform the assigned work.
* A master's degree is preferred and may substitute for the required experience.
Experience:
* Must have at least two (2) years or more of related healthcare experience, preferably in a large healthcare system, or prior clinical research experience.
* Lab experience preferred.
Specialized Training:
* Must have Human Subjects Protection Training or be able to obtain within 14 days of hire.
Certification/Licensure:
* Must possess a current valid Arizona driver's license.
* Prefer SoCRA certification as Certified Clinical Research Professional, or an ACRP/APCR certification as a CRA, CRC, or PI.
* Requires a BLS card obtained through an approved American Heart Association (AHA) training center within 3 months.
Knowledge, Skills, and Abilities:
* Must have excellent communication (oral and written) and presentation skills.
* Must be proficient in medical terminology.
* Must have strong computer skills in Microsoft Office applications.
* Requires excellent project management skills and interpersonal communication abilities.
* Must have the ability to rotate being on-call and the ability to travel.
* Requires the ability to read, write, and speak effectively in English.
* Bilingual is a plus.
Clinical Research Associate - Phoenix, Arizona
Clinical Research Coordinator Job 6 miles from Mesa
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) to perform monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
This is a Hybrid position - We are looking for someone that currently lives in the Phoenix, Arizona area - and that is able to go to the Tempe site on a regular basis.Primary Responsibilities:
Clinical monitoring and site management for national and international clinical studies of phases I-IV
Regulatory activities with authorities, ethics committees and investigators
Project management support and in-house activities for clinical research projects
Sponsor communication and contact
Requirements:
BA/BS degree in biomedical-related field, life sciences or equivalent field
Two years working experience in clinical research, as a CRA, Study Nurse or related profession preferred
One year experience in on-site monitoring preferred
Excellent oral and written communication skills in English
High level of organization, multi-tasking, judgement, and keeping to timelines
Profound knowledge of ICH-GCP and other relevant regulatory requirements
Flexible and willing to possibly travel to other sites
Anticipate & prevent problems. Able to create backup plans
*Equivalent education and experience will be considered
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Clinical Research Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
Our Clinical Research Coordinator is a specialized research professional working with and under the direction of the Principal Investigator (PI) and Clinical Research Manager. They are responsible for conducting and supporting the assessment, planning, implementation, and execution of research protocols. They also support and facilitate the daily clinical trial activities and take on a supportive role in the conduct of site studies.
Schedule: Onsite, Monday through Friday
What You'll Do:
* Participates in initiation and maintenance of study protocols
* Completes procedures throughout study visits including, but not limited to, collection of vitals and ECGs, phlebotomy, blood processing, collection of height and weight, conducting subject questionnaires, and other protocol specific items
* Processes blood, urine, and biopsy samples in accordance with study protocols and IATA/OSHA standards.
* Completes study source documentation, data entry into electronic data capture (EDC) systems, and maintenance of study files.
* Completes study visits per study protocol, inclusive of source document and case report form completion and submission
* Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
* Ensures clinical trial files are documented in accordance with company standard operating procedures, study protocol, and Good Clinical Practice (GCP).
* Pre-screens and screens potential research participants and clinical patients for enrollment and assists with implementing recruitment strategies.
Skills and Experience:
* Minimum of 1 year experience is required
* Knowledge of clinical research regulations and GCP guidelines
* Bilingual in Spanish is highly preferred
In support of our mission statement, "Healthier Practices, Healthier Patients", we have adopted a tobacco-free environment and we prefer NOT to hire tobacco and nicotine users, including the use of e-cigarettes/vaping.
Clinical Research Coordinator III (CRC3)
Clinical Research Coordinator Job 36 miles from Mesa
About Us:
Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.
Job Summary:
Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator III position in Peoria.
Title: Clinical Research Coordinator III (CRC3)
Compensation: $31.00 - $36.00 per hour, depending on experience and qualifications
Status: Full-time, Non-exempt, 40 hours, Monday-Friday
Location: Peoria, AZ (onsite)
Reports to: Senior Clinical Research Manager
Essential job functions/duties:
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.
Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.
Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
Develop management systems and prepare for study initiation
Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol
Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
Responsible for meeting recruitment goals for each study.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Serves as a liaison to all physicians, employees, and third-party vendors.
Screen and enroll study subjects
Review the study design and inclusion/exclusion criteria with the subject's primary physician
Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
Review the protocol, Informed Consent Form, and follow-up procedures with potential study subjects
Ensure the current approved Informed Consent is signed before subjects are screened and enrolled
Ensure that the randomization procedure is followed as per protocol guidelines
Document protocol exemptions and deviations.
Ensures that primary referring physicians receive timely progress notes.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Manage study-related activities, subject compliance and documentation
Ensure adherence to protocol requirements
Schedule subjects for follow-up visits
Assist investigators in assessment of subject response to therapy
Review laboratory data, inform investigator of abnormal values and document
Report to primary care provider as appropriate
Assess and document subject compliance with medications and visits
Communicate with pharmacy staff to assure timely and accurate study drug distribution
Manage administration of investigational therapy
Responsible for chain of custody and accurate accountability of investigation product and devices.
Maintain dispensing logs (if allowed)
Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
Oversee specimen collection, storage and shipment
Attend study-related meetings as appropriate
Communicate regularly with the Principal Investigator, monitor (and others responsible for conduct of the research) about study-related issues
Record data and study documentation
Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate.
Assign patient stipend pay card at screening
Document reason for screen-fail in real time
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Record data as directed using the appropriate media or platform
Follow procedures for access and security for electronic data entry
Review keyed data for accuracy as needed
Send data to the data collection center on a timely basis
Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
Develop and/or edit source as needed independently or with Quality Assurance / Quality Control team to
Ensure compliance with protocol and EDC.
Correct and edit data as directed and as appropriate.
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Document and record all AEs and SAEs as outlined in protocol
Monitor and report adverse events
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Responsible for administrative duties including filing documents related to subject's participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Ensure W-9 and medical release forms are signed by subjects annually.
Management of site activities during audits and inspections
Management of ancillary staff as assigned
Train and supervise support staff (e.g., CRC I)
Mentor for externs
Train newly hired employees as either Research Assistant and/or CRC
Prepare for quality assurance audits and regulatory inspections as needed
Act as contact person before, during and after audits and inspections
Provide all required documentation to auditors
Make all appropriate corrections as requested by auditors
Coordinate site response to audit/inspection findings.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Other responsibilities as delegated by manager.
Knowledge/Skills/Abilities required:
At least three (3) years of experience working previously as a clinical research coordinator for late phase clinical trials.
Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management).
A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
Interpersonal and communication skills-interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources.
Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
Knowledge of all active protocols and disease indications within the company and providing information
Knowledge of protocol specific and IRB specific reporting guidelines for protocol deviations, serious adverse events and other reporting requirements.
Able to perform all Job duties listed for Job Description for Phlebotomist
Know and understand all regulatory requirements associated with the conduct of the study assigned.
Travel requirements:
Some interoffice travel may be required with use of company vehicle or mileage reimbursement
Education, credentials, and/or trainings required:
Associates or Bachelor's degree in healthcare, clinical research management, or related required.
Master's degree or study-specific training preferred
GCP certification required at hire.
Experience and training in the conduct of clinical research and basic knowledge of medical terminology.
Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)
Experience with data management and tracking software
Benefits & Perks:
Health, Dental, Vision (with HSA plans and employer contribution)
PTO
Sick Time
401K with company match
Short & Long Term Disability
Educational Assistance
Shared company vehicles for required travel
Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.
EEO statement
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.
Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and forceful inquires may also be blocked across our network at the domain level as spam. Thank you for your understanding and cooperation.
Clinical Research Coordinator I
Clinical Research Coordinator Job 17 miles from Mesa
Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
Duties & Responsibilities:
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
a. Sponsor-provided and IRB-approved Protocol Training
b. All relevant Protocol Amendments Training
c. Any study-specific Manuals Training, as applicable
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
Submitting required administrative paperwork per company timelines.
Participating in subject recruitment and retention efforts.
Engaging with Research Participants and understanding their concerns.
Any other matters, as assigned by management.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Bachelor's degree a plus
Foreign Medical Graduates preferred
Experience:
At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting
Credentials:
ACRP or equivalent certification is preferred
Registered Medical Assistant certification or equivalent is preferred
Knowledge and Skills:
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Bilingual in Spanish is preferred
Study Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
Job Title: Study CoordinatorJob Description The Study Coordinator will be involved in human subject research. Participants will utilize various technology products, and the coordinator will monitor participants and collect data throughout the sessions. Each session can last up to 2.5 hours, during which the coordinator will work directly with participants to support data collection.
Responsibilities
+ Conduct participant consent procedures according to protocol.
+ Take necessary vitals and measurements (height, weight, EKG) at the beginning and throughout the session.
+ Ensure participants are properly set up with devices and monitoring equipment.
+ Use multiple pieces of instrumentation to observe participants using devices during various activities as per protocol.
+ Monitor data collection and ensure it is functioning properly throughout the session.
+ Guide participants through the study and ensure proper data collection.
Essential Skills
+ Background in science (Bachelor's degree in science, exercise science, kinesiology, biology).
+ Experience in research, data entry, and protocol implementation.
+ Ability to execute test protocols and operate test devices.
+ Technical proficiency to operate devices and perform data entry.
+ Ability to direct participants throughout the study.
Additional Skills & Qualifications
+ Familiarity with gym equipment and clinical research.
+ Experience with human subject research and data analysis.
Work Environment
The study coordinator will work in a simulated environment, standing for long periods and performing some desk work. There are two shifts available: morning shift from 7:30 AM to 3:00 PM and evening shift from 2:00 PM to 9:00 PM. Flexibility in shifts is provided to accommodate school schedules, making this an ideal opportunity for graduate students. One position is available for the day shift and four for the evening shift.
Pay and Benefits
The pay range for this position is $25.00 - $25.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Phoenix,AZ.
Application Deadline
This position is anticipated to close on Mar 18, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Study Coordinator
Clinical Research Coordinator Job 17 miles from Mesa
We are seeking a dedicated Study Coordinator to conduct human subject research. Participants will use various technology products, and you will monitor and collect data throughout the sessions. Each session lasts up to 2.5 hours, where you will work directly with participants to support data collection.
Responsibilities
* Conduct human subject research according to protocol.
* Obtain consent from participants and take necessary vitals and measurements (height, weight, EKG) at first and throughout the session.
* Ensure participants are properly set up with devices and monitoring equipment.
* Observe participants using devices during various activities as per protocol.
* Ensure data monitoring is functioning properly throughout the session.
* Collect data accurately and guide participants throughout the study.
Essential Skills
* Experience in science (Bachelor's Degree in science, exercise science, kinesiology, biology).
* Ability to execute test protocols.
* Technical proficiency to operate test devices and perform data entry.
* Capability to direct participants through the study.
* Familiarity with gym equipment and clinical research.
Additional Skills & Qualifications
* Experience in human subject research.
* Data analysis skills.
Work Environment
The work environment includes morning and afternoon shifts, with AM shifts starting as early as 7:30 AM to 2:00 PM and PM shifts from 2:00 PM to 9:00 PM. Shifts typically last 6 hours each. You will be on your feet for long periods, with some desk work, working with participants in a simulated environment. There are 4 openings for the day shift and 2 openings for the evening shift. This role offers flexibility in shifts to accommodate school schedules, making it an ideal opportunity for graduate students.
Pay and Benefits
The pay range for this position is $25.00 - $25.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Phoenix,AZ.
Application Deadline
This position is anticipated to close on Mar 14, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.