Clinical research coordinator jobs in Reno, NV - 852 jobs

Clinical Research Associate - Oncology - Los Angeles, CA ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced monitoring oncology trials required. Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Los Angeles, CA near major HUB airports to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

IDR is seeking a Clinical Research Associate to join one of our top clients in Los Angeles, CA. This role offers a unique opportunity to work onsite, fostering close collaboration with our client's team and immersing yourself in a dynamic work environment. If you are eager to be part of a growing organization with a team-oriented culture, please apply today! Position Overview/Responsibilities for the Clinical Research Associate: • Collaborate with the team to submit research projects for human subjects approval, including protocols, consent forms, and IRB applications. • Manage internal documentation for contract execution and maintain communication with contracting officers and sponsors during budgeting and negotiations. • Develop and monitor research project budgets, ensuring alignment with protocol requirements and institutional costs. • Ensure compliance with IRB, FDA, OHRP, HIPAA, and other guidelines by maintaining high-quality regulatory files and submitting necessary paperwork. • Coordinate site feasibility and initiation visits, and provide facility tours for research sponsors and other personnel. Required Skills for Clinical Research Associate: • High School Diploma or GED is required; a Bachelor's degree is preferred. • At least one year of experience in clinical research, with a preference for experience in chemo, oncology, or pharmaceutical research. • Strong organizational skills and attention to detail in managing research documentation and regulatory compliance. • Ability to collaborate effectively with internal and external investigators and participating centers. What's in it for you? Competitive compensation package Full Benefits; Medical, Vision, Dental, and more! Opportunity to get in with an industry-leading organization Close-knit and team-oriented culture Why IDR? 25+ Years of Proven Industry Experience in 4 major markets Employee Stock Ownership Program Medical, Dental, Vision, and Life Insurance ClearlyRated's Best of Staffing Client and Talent Award winner 12 years in a row

As a Senior Clinical Research Coordinator, you will play a pivotal role in managing and coordinating clinical trials. You will be responsible for study coordination, including study start-up, patient recruitment, and providing backup support. You will ensure that all aspects of the trial are managed efficiently and effectively, adhering to timelines and regulatory requirements. Responsibilities Serve as the primary contact to ensure appropriate communications, trial management, and meeting of timelines. Coordinate the operational aspects of new and ongoing clinical trials at the site. Work under the supervision of the Principal Investigator(s), exercising excellent clinical judgment in patient monitoring and care. Maintain daily contact with the Principal Investigator(s) for recruitment activities, study start-up, and general daily communication. Execute the protocol and ensure that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained. Recruit and pre-screen patients. Maintain and submit IRB communications and regulatory documents. Communicate timely with internal teams, investigators, review boards, and study subjects. Prepare study materials as requested by the Principal Investigator, such as informed consent documents, case report forms, enrollment logs, and drug/device accountability logs. Perform other duties as assigned. Essential Skills Patient recruitment Clinical trial management Clinical research Good Clinical Practice (GCP) Oncology Phlebotomy Additional Skills & Qualifications At least a High School Diploma Prior Clinical Research Coordinator experience (3+ years) Oncology experience Work Environment The position requires on-site work five days a week in a patient-facing clinic environment. Job Type & Location This is a Contract position based out of Los Alamitos, CA. Pay and Benefits The pay range for this position is $30.00 - $42.00/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 Los Alamitos,CA. Application Deadline This position is anticipated to close on Jan 19, 2026. 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Kelly Science and Clinical FSP is currently seeking a Sr Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time. This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. DUTIES & RESPONSIBILITIES* Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate client, procedures and guidelines, this position: Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones. Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures; May serve as the primary contact for clinical trial sites (e.g. site management); Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….), ensure registration on ********************** from study initiation through posting of results and support publications as needed; Management/oversight of ordering, tracking, and accountability of investigational products and trial materials; Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel; Oversee the development and execution of Investigator agreements and trial payments; Responsible for clinical data review to prepare data for statistical analyses and publications; If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need; May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects; If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center; Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated; Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs); Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders; Support project/study budget activities as assigned; Develop a strong understanding of the pipeline, product portfolio and business needs; Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures; Perform other duties assigned as needed; Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations. EXPERIENCE AND EDUCATION* Education Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required. Experience BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred. Previous experience in clinical research or equivalent is required. Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…). Clinical/medical background a plus. Medical device experience highly preferred Class III Medical Device experience (implantable) preferred REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional and Technical Competencies: Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations; Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations; Good presentation and technical writing skills; Good written and oral communication skills; Leadership Competencies: Ability to lead small study teams to deliver critical milestones, as may be assigned. Leadership required in alignment with J&J Leadership Imperatives: Connect - Develop collaborative relationships with key internal and external stakeholders. Shape - Make recommendations for and actively participate in departmental process improvement activities. Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations. Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations. LOCATION & TRAVEL REQUIREMENTS Primary location for this position is Irvine. Ability to travel approximately 20% depending on the phase of the program. EXTERNAL INTERACTIONS Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated. May have regular interaction with third party vendors supporting clinical studies as applicable per program.

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We can't sponsor H1B. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. Arcetyp LLC is looking for a Clinical Research Coordinator. This position is onsite and located in Okinawa, Japan. DUTIES AND RESPONSIBILITIES: Coordinates and participates in clinical research studies by performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Coordinates and implements procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Assists in the determination of guidelines for the collection of clinical data or administration of clinical studies. EDUCATION AND YEARS OF EXPERIENCE: Bachelor's Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years OR current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), OR Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) OR the Society of Clinical Research Associates (SoCRA). Minimum of 2 to 4 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. QUALIFICATIONS: Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge. Ability to communicate effectively, both orally and in writing. Possess effective organizational and analytical skills with ability to work independently and in a team environment. Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program. Candidate must possess active/current secret security clearance. Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date Min. Citizenship Status Required: U.S Citizenship. Physical Requirement(s): None Location: Okinawa, Japan COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.

Job Title: Clinical Trials Management Associate - III* Duration: 12+ Months Specific Job Responsibilities: Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required: • Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines • Assists in CRO or vendor selection • With guidance from supervisor coordinates CROs or vendors • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies • Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development) • Interfaces with individuals in other functional areas to address routine study issues • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives • Travel is required • Excellent verbal, written, interpersonal and presentation skills are required • Working knowledge and experience with Word, PowerPoint and Excel • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures • Ability to develop tools and processes that increase measured efficiencies of the project • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals • Must have a general understanding of functional issues and routine project goals from an organizational perspective. Specific Education & Experience Requirements: • 4+ years of experience and a BS or BA in a relevant scientific discipline • 4+ years of experience and an RN (2 or 3 year certificate) • CCRA or other certification desired

** Seeking a Clinical Research Coordinator in Las Vegas, Neveda** Reports To: Senior Clinical Research Site Manager Department: Clinical Research Operations Employment Type: Full-time, onsite, 40 hrs a week Position Overview The Clinical Research Coordinator (CRC) plays a key role in the successful execution of clinical research studies by supporting investigators and ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), and applicable regulatory guidelines. This position involves direct participant interaction, study coordination, and accurate documentation throughout all phases of clinical trials. Key Responsibilities -Collaborate closely with Principal Investigators to coordinate all aspects of assigned clinical studies, including participant recruitment, eligibility assessment, scheduling, treatment coordination, and study-related procedures. -Perform clinical and study-related procedures, including phlebotomy, vital signs collection, centrifuge operation, ECG administration, and other protocol-required tasks. -Utilize Microsoft Office and electronic research systems efficiently, including source documentation platforms, IXRS/IWRS, and Electronic Data Capture (EDC) systems such as Medidata, Veeva, and Inform. - Monitor participant health status throughout the study and promptly communicate relevant findings to the Principal Investigator. -Identify, document, and report Serious Adverse Events (SAEs) and other safety concerns to investigators and sponsors in accordance with protocol and regulatory requirements. -Coordinate the collection, processing, packaging, and shipment of biological specimens to designated central laboratories, ensuring accuracy and compliance with laboratory and shipping guidelines. -Maintain accurate, complete, and organized study documentation in compliance with GCP and regulatory standards. Qualifications -Minimum of 3 years of hands-on experience as a Clinical Research Coordinator, preferably in Phase II-IV pharmaceutical clinical trials. -Bachelor's degree in a scientific, healthcare, or related field. -Strong attention to detail with the ability to maintain accurate and well-organized research records. -Excellent written and verbal communication skills, with the ability to interact professionally with investigators, sponsors, participants, and study team members. -Working knowledge of ethical principles, regulatory requirements, and GCP guidelines governing clinical research. -Ability to recognize potential risks, protocol deviations, and adverse events and respond promptly and appropriately.

Contract Mountain View, CA $31 - $36/hour Certified Clinical Research Coordinator - Join a Leading Research Team! Have a chance to drive meaningful research and be a part of a TOP research team conducting clinical trials. This is an incredible opportunity to make a lasting impact by engaging in studies that aim to improve treatments and uncover lasting cures! Responsibilities: Gather consent and determine eligibility for study participants Coordinate collection of specimens Ensure compliance with research protocols Assemble kits for study visits Prepare regulatory submissions Monitor expenditures and budgets Extract, analyze, and interpret research data to support study objectives Qualifications: Minimum 2 years of experience in clinical research Bachelor's degree Experience with EPIC is preferred Experience with treatment trials is required If this opportunity is of particular interest, apply now, and we'll be happy to share the details with you!

Highlights $70,000 - $79,000 annual salary based on experience Great benefits including 401k w/match and 15 days PTO Consistent schedule, no overnights or weekends Work with cutting edge research trials and a great team About Our Client Our client is a fast growing site network that currently has over 30 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: oncology, cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors. Responsibilities As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process! Conduct procedures such as vital signs, blood draws, EKGs, and scans. Patient recruitment, enrollment, scheduling, and consent Lab procedures and shipments Maintain GCP and follow protocols Data management in EDC systems Overall coordination of the study from start up to close out Qualifications: 2+ years of experience working as a CRC on sponsor backed clinical trials Phlebotomy and lab processing experience (ability to perform without supervision) Ability to work on site M-F on site (there is no remote or hybrid days)

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties and tasks may be assigned. GROWTH * Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments. * Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels. * Demonstrate effective use of supplies and staff labor hours. * Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing. * Perform duties as assigned to meet the patient care or operational needs of the clinic. OUTCOMES * Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare. * Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals. * Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality. * Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals. * Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management. OPERATIONAL READINESS * Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements. * Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations. * Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys. * May assume Charge Nurse's responsibilities as needed. * May fulfill responsibility of facility Alternate CEO as delegated by Governing Body. * Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director, and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated. * Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator. * Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. * Oversee the maintenance of equipment and supplies to meet current laws and regulations. * Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures. * Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center. * Know and understand the water treatment and mechanisms of the equipment of the facility. * Assist, when necessary, with disinfection of equipment and supplies including bicarbonate delivery systems and dialysis machines. PARTNERSHIPS * Maintain collaborative working relationship with Medical Director and physicians. * Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community. * Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization. * Respond effectively to inquiries or complaints. STAFF DEVELOPMENT/ RETENTION * Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations. * Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary. * Assists with recruitment, training, development, and supervision of all personnel. * Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees. * Uphold management goals of corporation by leading staff in team concepts and promoting a team effort. * Effectively communicate expectations; accept accountability and hold others accountable for performance.

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? * ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. * Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. * Work with a collaborative team with the ability to work across different areas of the company. * Ability to join a growing company with professional development opportunities. Position Summary Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies. Essential Functions Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals. Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems. Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues. Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival. Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents. Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission. Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval. Facilitate the collection and review of required study documents during site start-up Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) Route study documents to the appropriate personnel for validated digital signatures Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee. Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions. Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree with 0-2 years of clinical research experience required; or High school diploma with 5+ years of clinical research experience required Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Maintain corporate confidentiality at all times. Strong oral and written communication skills Detail oriented, with solid organization and time management skills Working knowledge of good documentation practices (GDP) Working Environment / Physical Environment This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $70,000 (entry-level qualifications) to $77,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $73,800 (entry-level qualifications) to $81,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

At Stantec, we help deliver the critical minerals needed to power our world, from the cars we drive to the infrastructure powering our communities. And we don't just design the largest, deepest, and most technically challenging mines in the world-we do it sustainably. We're helping clients reduce energy usage, adopt clean energy sources, and implement digital solutions and automation. Join our team of mining professionals and you'll be at the forefront of this evolving industry while building the mine of the future. You'll also build your own future, with exciting opportunities for development and advancement. Your Opportunity We are currently seeking a Study Manager to join our Mining team in the Southwest USA, based out of one of our offices in Chandler, AZ or Tucson, AZ. The Study Manager is the principal liaison between Stantec and the client during the planning and execution of mining studies. The successful candidate will drive the identification, evaluation, selection, and/or optimization for a variety of mining projects as a key service offering for our diverse client base. You will have the opportunity to successfully steer complex studies through our various clients' stage gate processes, developing and applying robust study management techniques, while leading a multi-disciplinary team across multiple offices. Your Key Responsibilities - Understand the client's objectives and study definition guidelines. - Drive the scope definition and execution planning for each study, working with a multi-disciplinary team to translate the client's objectives and study definition guidelines into an actionable, controllable scope of work and plan of execution. - Implement study management processes and procedures, including risk and value management, option identification/evaluation/selection, and assurance activities as required. - Deliver integrated studies on time and within budget, while ensuring alignment between engineering, estimating, scheduling and risk from Order-of-Magnitude / Preliminary Economic Assessments through to Definitive Feasibility Studies. - Serve as a technical peer reviewer or Qualified Person in the execution of the technical components of the work. Answer questions and give daily guidance and communications to the project team, thus developing the team's technical competence. - Assist the client with crafting the story of their studies, including engagement with other client stakeholders to present the progress and/or outcomes. - Understand and implement various stage gate study standard processes. - Proven Mining Study or Project leadership experience with high emotional intelligence. - Influential leader, capable of weighing contradicting priorities and securing buy-in on compromise. - Risk management, commercial awareness, business analysis & reporting, and operational/business knowledge. - Excellent communication and collaboration skills. - An ability to effectively liaise with external and internal stakeholders from multiple cultures. - Comfort in managing a complex environment with a virtual team based around the world. - High degree of leadership, planning, teamwork, decision-making, judgment, and problem-solving skills. - An aptitude for steering multi-disciplinary teams towards a common objective. - Proven history of managing ambiguity and maintaining team progress during periods of significant change. - Assessor of value and risk. Education and Experience - Bachelor's degree in Engineering, or a related field from an accredited university is preferred. - Professional Engineering license (or the ability to obtain a license) is preferred. - Minimum of 10 years of relevant study/project and/or program management experience. - Direct study experience in the mining and or heavy industry sectors is advantageous. - A Master of Business Administration degree, while not necessary, is viewed as an asset. This description is not a comprehensive listing of activities, duties or responsibilities that may be required of the employee and other duties, responsibilities and activities may be assigned or may be changed at any time with or without notice. Stantec is a place where the best and brightest come to build on each other's talents, do exciting work, and make an impact on the world around us. Join us and redefine your personal best. #FeelingEnergized **Pay Transparency:** In compliance with pay transparency laws, pay ranges are provided for positions in locations where required. Please note, the final agreed upon compensation is based on individual education, qualifications, experience, and work location. At Stantec certain roles are bonus eligible. Actual compensation for part-time roles will be pro-rated based on the agreed number of working hours per week. **Benefits Summary:** Regular full-time and part-time employees (working at least 20 hours per week) have access to medical, dental, and vision plans, a wellness program, health saving accounts, flexible spending accounts, 401(k) plan, employee stock purchase program, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage and paid family leave. Regular full-time and part-time employees will receive ten paid holidays in each calendar year. In addition, employees will be eligible to accrue vacation between 10 and 20 days per year and eligible for paid sick leave (and if more generous, in accordance with state and local law). Temporary/casual employees have access to 401(k) plans, employee stock purchase program, and paid leave, in accordance with state and local law. The benefits information listed above may not apply to union positions because benefits for such positions are governed by applicable collective bargaining agreements **Primary Location:** United States | NV | Reno **Organization:** BC-1829 Mining-US **Employee Status:** Regular **Travel:** Yes **Schedule:** Full time **Job Posting:** 01/11/2025 12:11:51 **Req ID:** 1002869 Stantec provides equal employment opportunities to all qualified employees and applicants for future and current employment and prohibit discrimination on the grounds of race, colour, religion, sex, national origin, age, marital status, genetic information, disability, sexual orientation, gender identity or gender expression. We prohibit discrimination in decisions concerning recruitment, hiring, referral, promotion, compensation, fringe benefits, job training, terminations or any other condition of employment. Stantec is in compliance with laws and regulations and ensures equitable opportunities in all aspects of employment. At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable adjustments to be made during the recruitment process then please inform a member of our Talent Acquisition team.

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

As a Senior Clinical Research Coordinator, you will play a pivotal role in managing and coordinating clinical trials. You will be responsible for study coordination, including study start-up, patient recruitment, and providing backup support. You will ensure that all aspects of the trial are managed efficiently and effectively, adhering to timelines and regulatory requirements. Responsibilities + Serve as the primary contact to ensure appropriate communications, trial management, and meeting of timelines. + Coordinate the operational aspects of new and ongoing clinical trials at the site. + Work under the supervision of the Principal Investigator(s), exercising excellent clinical judgment in patient monitoring and care. + Maintain daily contact with the Principal Investigator(s) for recruitment activities, study start-up, and general daily communication. + Execute the protocol and ensure that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained. + Recruit and pre-screen patients. + Maintain and submit IRB communications and regulatory documents. + Communicate timely with internal teams, investigators, review boards, and study subjects. + Prepare study materials as requested by the Principal Investigator, such as informed consent documents, case report forms, enrollment logs, and drug/device accountability logs. + Perform other duties as assigned. Essential Skills + Patient recruitment + Clinical trial management + Clinical research + Good Clinical Practice (GCP) + Oncology + Phlebotomy Additional Skills & Qualifications + At least a High School Diploma + Prior Clinical Research Coordinator experience (3+ years) + Oncology experience Work Environment The position requires on-site work five days a week in a patient-facing clinic environment. Job Type & Location This is a Contract position based out of Los Alamitos, CA. Pay and Benefits The pay range for this position is $30.00 - $42.00/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 Los Alamitos,CA. Application Deadline This position is anticipated to close on Jan 19, 2026. 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

WHAT YOU WILL DO As a Clinical Coordinator (RN) you will be responsible for the delivery of safe, quality care of dialysis treatments by assisting the Center Manager (CM) with oversight of the center's operations and by providing direct patient care. The Clinical Coordinator (RN) acts as a team leader who educates and mentors center staff as appropriate. In the absence of the CM, this position is also responsible for the daily management of the center. WHAT WE EXPECT OF YOU You will play a vital role to ensure that we deliver on our Mission to make life better for those with kidney disease and our Vision to be unsurpassed in our individualized experience, our quality, and our compassion. You approach your work with an indisputable sense of greater purpose. Lastly, you are high energy, seek out opportunities to improve the environment for patients and staff, are goal-oriented, and gain deep satisfaction from building relationships. WHAT YOU WILL GAIN Relationships: You will work directly with a multi-disciplinary team that is as passionate as you in making a difference in others' lives. You will become a servant leader, bringing up your team to provide care that is unsurpassed by others in our industry. Impact: You will set the tone that enables our patients to live a better life and address their needs holistically. You will make a difference for our patients so that they do dialysis to live instead of living for dialysis. Growth: You will have formal and informal opportunities for professional growth in a supportive environment. You will become a subject-matter expert and have a wide range of opportunities for career advancement. MINIMUM QUALIFICATIONS Experience One (1) year of nursing experience required; 1 year of hemodialysis nursing required. Supervisor/Charge Nurse experience preferred Education Graduation from an accredited school of nursing or equivalent; BSN preferred License/Certification Current State license as a Registered Nurse Current CPR/BLS for Healthcare certification (or within 3 months of hire) CNN or CDN certification preferred #SHLLC

At Stantec, we help deliver the critical minerals needed to power our world, from the cars we drive to the infrastructure powering our communities. And we don't just design the largest, deepest, and most technically challenging mines in the world-we do it sustainably. We're helping clients reduce energy usage, adopt clean energy sources, and implement digital solutions and automation. Join our team of mining professionals and you'll be at the forefront of this evolving industry while building the mine of the future. You'll also build your own future, with exciting opportunities for development and advancement. Your Opportunity We are currently seeking a Study Manager to join our Mining team in the Southwest USA, based out of one of our offices in Chandler, AZ or Tucson, AZ. The Study Manager is the principal liaison between Stantec and the client during the planning and execution of mining studies. The successful candidate will drive the identification, evaluation, selection, and/or optimization for a variety of mining projects as a key service offering for our diverse client base. You will have the opportunity to successfully steer complex studies through our various clients' stage gate processes, developing and applying robust study management techniques, while leading a multi-disciplinary team across multiple offices. Your Key Responsibilities * Understand the client's objectives and study definition guidelines. * Drive the scope definition and execution planning for each study, working with a multi-disciplinary team to translate the client's objectives and study definition guidelines into an actionable, controllable scope of work and plan of execution. * Implement study management processes and procedures, including risk and value management, option identification/evaluation/selection, and assurance activities as required. * Deliver integrated studies on time and within budget, while ensuring alignment between engineering, estimating, scheduling and risk from Order-of-Magnitude / Preliminary Economic Assessments through to Definitive Feasibility Studies. * Serve as a technical peer reviewer or Qualified Person in the execution of the technical components of the work. Answer questions and give daily guidance and communications to the project team, thus developing the team's technical competence. * Assist the client with crafting the story of their studies, including engagement with other client stakeholders to present the progress and/or outcomes. * Understand and implement various stage gate study standard processes. * Proven Mining Study or Project leadership experience with high emotional intelligence. * Influential leader, capable of weighing contradicting priorities and securing buy-in on compromise. * Risk management, commercial awareness, business analysis & reporting, and operational/business knowledge. * Excellent communication and collaboration skills. * An ability to effectively liaise with external and internal stakeholders from multiple cultures. * Comfort in managing a complex environment with a virtual team based around the world. * High degree of leadership, planning, teamwork, decision-making, judgment, and problem-solving skills. * An aptitude for steering multi-disciplinary teams towards a common objective. * Proven history of managing ambiguity and maintaining team progress during periods of significant change. * Assessor of value and risk. Education and Experience * Bachelor's degree in Engineering, or a related field from an accredited university is preferred. * Professional Engineering license (or the ability to obtain a license) is preferred. * Minimum of 10 years of relevant study/project and/or program management experience. * Direct study experience in the mining and or heavy industry sectors is advantageous. * A Master of Business Administration degree, while not necessary, is viewed as an asset. This description is not a comprehensive listing of activities, duties or responsibilities that may be required of the employee and other duties, responsibilities and activities may be assigned or may be changed at any time with or without notice. Stantec is a place where the best and brightest come to build on each other's talents, do exciting work, and make an impact on the world around us. Join us and redefine your personal best. #FeelingEnergized Pay Transparency: In compliance with pay transparency laws, pay ranges are provided for positions in locations where required. Please note, the final agreed upon compensation is based on individual education, qualifications, experience, and work location. At Stantec certain roles are bonus eligible. Actual compensation for part-time roles will be pro-rated based on the agreed number of working hours per week. Benefits Summary: Regular full-time and part-time employees (working at least 20 hours per week) have access to medical, dental, and vision plans, a wellness program, health saving accounts, flexible spending accounts, 401(k) plan, employee stock purchase program, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage and paid family leave. Regular full-time and part-time employees will receive ten paid holidays in each calendar year. In addition, employees will be eligible to accrue vacation between 10 and 20 days per year and eligible for paid sick leave (and if more generous, in accordance with state and local law). Temporary/casual employees have access to 401(k) plans, employee stock purchase program, and paid leave, in accordance with state and local law. The benefits information listed above may not apply to union positions because benefits for such positions are governed by applicable collective bargaining agreements Primary Location: United States | NV | Reno Organization: BC-1829 Mining-US Employee Status: Regular Business Justification: Replacement Travel: Yes Schedule: Full time Job Posting: 01/11/2025 12:11:51 Req ID: 1002869 Stantec provides equal employment opportunities to all qualified employees and applicants for future and current employment and prohibit discrimination on the grounds of race, colour, religion, sex, national origin, age, marital status, genetic information, disability, sexual orientation, gender identity or gender expression. We prohibit discrimination in decisions concerning recruitment, hiring, referral, promotion, compensation, fringe benefits, job training, terminations or any other condition of employment. Stantec is in compliance with laws and regulations and ensures equitable opportunities in all aspects of employment. At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable adjustments to be made during the recruitment process then please inform a member of our Talent Acquisition team.

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.