div>Celerion, a leader in clinical research, is seeking a full-time
Lead, Clinical Research Associate to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
Celerion is committed to swift, exceptional clinical research through translational medicine.
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. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 138 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit Health and Proxima Careers are partnering to expand access to healthcare careers by providing training, job placement, and ongoing support, helping community members achieve stable, well-paying jobs.
The Clinical Research Training and Compliance Coordinator is responsible for developing and overseeing a comprehensive training strategy that supports clinical research operations across medical devices, LDTs, and related programs, ensuring alignment with GCP, FDA, ICH, ISO 14155, and other applicable regulations while promoting inspection readiness and operational excellence. In partnership with Clinical Research Leadership, Study Operations, and Quality Assurance, this role designs and maintains role-based curricula for key functions, supports onboarding and ongoing competency development, and drives continuous improvement of learning programs in alignment with evolving regulations, internal policies, and business initiatives.
p>Relationship Management & Site Support: Builds deep, multi-stakeholder relationships at strategic sites (including investigators, pharmacists, and administration), acting as a "site champion" and Primary Point of Contact to maintain cross-study consistency and address site needs. Cross-Functional Collaboration & Reporting: Partners seamlessly with internal teams (e.g., Medical Affairs, Study Start-Up) and CROs to ensure unified site communication, while maintaining meticulous documentation of site visits and interactions in central systems (e.g., Veeva).
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties: Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area. This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol.
ul>Provides nursing care to research study patients, including: Performs and/or schedules medical tests within the scope of nursing licensure including, but not limited to, laboratory tests, vital sign readings, imaging studies, cardiac and/or pulmonary function tests, and psychological evaluations.
- Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines, including:
Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
Chandler, Arizona30+ days ago
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. Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation and trial management).
Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: • Assisting in the recruitment and screening of volunteers; • Registering patients; • Providing information on clinical trials and protocols to interested participants in a timely and helpful manner; • Obtaining relevant medical history on candidates by phone and in person; • Collecting previous relevant medical records data on patient; • Explaining procedures and consent forms; • Compiling all information prior to the initial visit; • Responding to inquiries from study participants or collateral informants in a timely and helpful manner; • Updating databases with patient information; • Performing other related activities. The department conducts Phases 1-3 treatment clinical trials covering all disease groups with the goal to provide support to the physician investigators and to provide trial treatment options to the patients in a safe and ethical manner, while ensuring compliance to the FDA and institutional regulations.
p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress.
Certifications/Licenses, Education, and Experience:
- Bachelor's Degree preferred, or equivalent combination of education, training, and experience.
Phoenix, Arizona30+ days ago
p style="text-align:inherit"/>Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
Conduct site facing presentations introducing study opportunities, data sharing and honest broker procedures/workflows, regulatory requirements, clinical trial matching and enrollment services, and system integrations (research and testing).
p>Key Responsibilities: • Developing and implementing feasibility strategies to evaluate site capabilities • Analyzing trial designs and recommending appropriate sites • Identifying recruiting and onboarding participating hospitals and health systems • Providing targeted education and training to sites and stakeholders • Overseeing protocol start-up, regulatory monitoring, and sponsor-level implementation activities • Collaborating with internal teams and external partners to meet project deliverables on time • Communicating progress and challenges to leadership • Working closely with the Clinical Trial Liaison and Study Operations teams to strengthen study center engagement, improve patient enrollment, and ensure regulatory compliance.
• Bachelors degree or equivalent health sciences field preferred or registered nursing certification • 3-5 years of experience in clinical research, healthcare, or public health-related programs • Strong project management skills • Superior organizational and time management skills • Ability to manage multiple concurrent tasks and prioritize accordingly • Strong medical or clinical research background.
p>Licensed or experienced Optician (ABO certification preferred) Strong understanding of optical dispensing, lens types, and frame adjustments Familiar with refraction principles and visual acuity measurement (Snellen, ETDRS) Excellent communication and organizational skills Comfortable working with patients in a clinical setting Prior experience in ophthalmology or research is a plus but not required. DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease.
Scottsdale, AZ30+ days ago
Minimum Education and/or Experience Required: (Education Requirements and Experience): HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Position Overview: (Major Functions and Non-Essential Functions): Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.