Clinical Research Assistant jobs at Banner Health

- 389 jobs

Associate Clinical Research Coordinator Oncology
Banner Health 4.4
Clinical research assistant job at Banner Health
Primary City/State: Gilbert, Arizona Department Name: Research Work Shift: Day Job Category: Research Good health care is key to a good life. At Banner Health, we understand that, and that's why we work hard every day to make a difference in people's lives. Do you like the idea of making a positive change in people's lives - and your own? If so, this could be the perfect opportunity for you. Banner MD Anderson Cancer Center Clinical Trials Office is the oncology service line for Banner Research. The department operates in Banner MD Anderson Cancer Center and Banner Gateway Medical Center. The department conducts Phases I-III 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. As an Associate Clinical Research Coordinator in Oncology, you will play a vital role in supporting the conduct of clinical research studies by managing key operational tasks and ensuring accurate data collection and entry. Working under the guidance of a Clinical Research Coordinator or RN Specialist, you will coordinate study protocols, schedule appointments and procedures, and maintain ongoing communication with study participants. Your responsibilities will include screening and enrolling participants, verifying eligibility, obtaining informed consent, and reviewing medical histories. You will also maintain patient calendars, manage research databases, perform quality reviews, and prepare and submit reports, all while ensuring compliance with study protocols and regulatory requirements. This is a unique opportunity where you can apply your established research or oncology experience to groundbreaking oncology research that directly impacts patient care and advances medical knowledge, join a team where your work truly makes a difference. 2yrs of Clinical Research Required Schedule: Monday - Friday 8am-5pm Experience innovative technology and exceptional opportunities for growth and development at Banner Health's state-of-the-art hospital Banner Gateway Medical Center. With comprehensive electronic medical records, physician order entry, digital radiography and proprietary advanced patient monitoring, Banner Gateway provides you with the innovative resources you need to provide your patients with the best care possible. Our commitment to nursing excellence has enabled us to achieve Magnet recognition by the American Nurses Credentialing Center. Located near Phoenix in Gilbert, Ariz., Banner Gateway Medical Center offers 286 private rooms, 13 operating suites, a 46-bed emergency department and shares a campus with the Banner MD Anderson Cancer Center. Our WIS and NICU services support an average of 4,000 deliveries per year. Key specialties include oncology, obstetrics, bariatric surgery, emergency and other services that focus on meeting the changing needs of the dynamic and growing community we serve. Banner MD Anderson Cancer Center Located in Gilbert, Ariz. (the Phoenix Metro area) on the Banner Gateway Campus, the center provides world-class care for oncology patients - both inpatient and outpatient - and has also brought leading oncology programs to the Banner Gateway campus including designation as a Stem Cell Transplant Center of Excellence and comprehensive Head & Neck cancer care. Our capabilities include five linear accelerator vaults, a brachytherapy vault, an advanced diagnostic imaging suite with PET/CT scan, more than 70 infusion bays, a cryopreservation lab and much more. Our inpatient medical oncology unit also incorporates a program that utilizes the electronic surveillance partnership in caring for the patient, where remote nurses have the ability to interact with patients via two-way audio-video to assist the bedside nurse with patient care. POSITION SUMMARY This position is responsible for providing research clinical conduct and data collection and entry support for clinical research studies. Duties include handling key operational functions for research studies and abstracting relevant research related data from medical records and source documents, populating, and coordinating use of research data bases and data sources, participant consenting, screening, enrollment, quality review, training, report production, and submission of collected research data. CORE FUNCTIONS 1. Under the direction of the RN Specialist, Clinical Research Coordinator or principal investigator, coordinates research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants. 2. Maintains patient calendars, screening, and enrollment information utilizing departmental databases/tools to ensure compliance with protocol requirements. 3. Completes initial intake on participants for research studies. Determines participant eligibility based on study specific criteria. Verifies that patients have completed appropriate registration materials and maintains related records and information. Obtains and reviews relevant medical history with participants. 4. Accountable for completing entire informed consent process, which includes proper consent discussion & documentation according to Good Clinical Practice (GCP) guidelines and departmental SOPs while assuring compliance with all relevant IRB and applicable regulatory agency requirements. 5. Collects required data by utilizing Cerner and other electronic databases, records obtained from external physician's offices, patient interviews, and other sources. Accurately enters data into the clinical research forms through computerized databases. 6. Maintains and updates department specific databases. Develops and implements efficient data collection tools and methods. Develops and manipulates spreadsheets. Performs internal data quality reviews for accuracy and quality of data collection. Prepares, updates, and organizes tracking logs and patient research files. Identifies and communicates important protocol and data management issues or problems to leadership. 7. Submits data to appropriate agencies and maintains established quarterly reporting rates. Uses electronic data capture. Complies with federal reporting requirements. Answers requests for requested data, extracts data from assigned facility data base and generates reports as needed. Submits forms and other reports in a timely manner and maintains all source documentation. Performs data outcomes analysis, creates data reports, and works on special data management projects as assigned. 8. Facilitates monitoring and audit related activities as directed and assists in training of new staff members as directed. 9. May serve as a backup, collecting and processing phlebotomy specimens for analysis using appropriate or specified equipment. Ensures proper labeling and obtains pertinent clinical and protocol information on request forms. Performs vital signs and EKG as appropriate. MINIMUM QUALIFICATIONS Must possess relevant knowledge as typically obtained by completion of an Associate's degree in healthcare, research, or related field and two years previous research experience. Two years of health care experience or equivalent knowledge/experience in a healthcare or research setting will also be considered. Knowledge of regulatory affairs and current issues concerning the conduct of clinical research or health care operations. Knowledge of medical terminology and the ability to interpret laboratory reports and understand disease processes and testing with an understanding of disease staging and status. Effective interpersonal skills with the ability to provide effective customer service. Must be proficient with common office software including web based and ability to conduct computer-based literature searches. PREFERRED QUALIFICATIONS Bachelor's Degree with previous pertinent experience working in a clinical research setting. Additional education or experienced preferred. EEO Statement: EEO/Disabled/Veterans Our organization supports a drug-free work environment. Privacy Policy: Privacy Policy
$44k-61k yearly est. Auto-Apply 13d ago
Clinical Research Informatician
Keck Medicine of USC 4.8
Los Angeles, CA jobs
The Clinical Research Informatician is a bridge between clinicians/researchers and data. They blend their knowledge of clinical workflow, terminology, and practices with an understanding of health information technology to advance clinical and translational research towards improved patient care. The Clinical Informatician will play an integral role focused on creating, testing, implementing, and maintaining applications and data for clinical areas. Responsibilities include acting as a liaison between clinicians/researchers and data stewards, interfacing with stakeholders on informatics software development, maintenance, and operations, and creating streamlined workflows for the exploitation of healthcare data. Minimum Education Bachelor's Degree In Health Information Management or Health Informatics OR B.S. in clinical field (nursing, etc.) and certification in Health Informatics OR B.S. in informatics, computer science, statistics, biomedical engineering artificial intelligence AND certification in Health Informatics required. Master's Degree preferred. Minimum Experience/Accountabilities Minimum 4 years' experience in clinical research Minimum 4 years' experience in clinical informatics Minimum 4 years' experience in information technology and/or in academic healthcare setting Experience with clinical operations, Health Information Management, or care management. Experience with clinical definitions, ontologies, dictionaries, and taxonomies required. Experience with clinical standards and coding. Experience with KPIs as they relate to clinical areas. Experience implementing new technologies in clinical areas. General clinical experience accepted, including experience as an MD, NP, PA, or RN. Experience serving as a liaison between clinicians/researchers and IT. Experience interpreting healthcare data using self-service tools or programming languages such as SQL and Python. Accountabilities: Collect, organize, curate, and document healthcare information within the data warehouse. Apply experience with clinical information and workflows to the development of informatics tools, applications, analyses, and procedures. Develop, modify, test, and implement applications and algorithms for the collection, organization, and analysis of healthcare data. Assist in the development of presentations, scientific publications, and grant proposals. Apply insights gained from research to improve patient care or healthcare operations. Ability to interact directly with and interpret healthcare data using self-service tools or coding languages, such as SQL and Python Ability to liaison between clinical stakeholders and Enterprise Data & AI technical team members Expertise in analyzing and optimizing clinical workflows, leveraging IT to enhance efficiency, accuracy, and patient outcomes through targeted interventions and system improvements. Collaborate with software vendors and IT service providers to ensure that their products and services are tailored to meet the unique operational needs of the healthcare facility, optimizing performance and compliance. Other duties as assigned.
$55k-75k yearly est. 2d ago
Senior Clinical Coordinator
University Health 4.6
Pleasanton, CA jobs
Senior Clinical Research Coordinator Full-Time - Day Shift Advance the Future of Clinical Research Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research. What You'll Do As a Senior Clinical Research Coordinator , you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will: Evaluate and provide expert clinical and risk assessment on research protocols and procedures Assist the Director with implementing a robust Human Subjects Protection Program Serve as a departmental representative to internal and external research committees, including IRB and OHRP Coordinate, monitor, and educate staff on best practices in research compliance and study execution Support grant applications, budgeting, and program planning across diverse research initiatives What We're Looking For Education & Experience: Required: Bachelor's of Science in Nursing (BSN) from an accredited institution Minimum 3 years of clinical research experience Working knowledge of research methods and federal regulations for human subject research Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire Core Competencies: Strong leadership and judgment in confidential, regulatory, and ethical matters Ability to navigate complex research protocols with a sharp eye for detail Confident representing the department in multi-institutional settings Excellent communication, planning, and coordination skills Why Join Us? At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer: A dynamic, collaborative, and mission-driven environment Opportunities to lead and influence policy at the institutional and national levels A commitment to professional development and clinical research excellence The chance to make a real impact on groundbreaking studies and healthcare transformation Ready to Elevate Clinical Research? Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.
$56k-77k yearly est. 1d ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Remote
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
$54.4k-80.1k yearly Auto-Apply 24d ago
Clinical Research Coordinator, Sr - Floater
U.S. Renal Care, Inc. 4.7
Remote
The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.
$47k-76k yearly est. 8h ago
Clinical Research Scientist
Genentech 4.5
South San Francisco, CA jobs
The Opportunity The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 1b-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. The Clinical Scientist supports the molecule/study/project team for effective and efficient Clinical Development Plan (CDP) execution. This includes contributing to clinical documentation, supporting training of study site personnel, acting as a point-of-contact for questions and enquiries to clinical studies, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting. Clinical Scientists perform their responsibilities with considerable guidance and direction from more experienced Clinical Scientists and Medical Directors. This position is located on-site in San Francisco, CA. Key Responsibilities You will provide support in developing and/or preparing clinical science information for inclusion into the CDP. You will contribute (with guidance from the Lead Clinical Scientist) to protocol/ICF (writing or amendment), construct appropriate CRFs and coordinate these items cross-functionally as needed; you will contribute (with guidance) to internal/external clinical presentations and communications (e.g. investigator meetings, study site interactions, patient information, study newsletters); You will present at appropriate internal meetings, e.g. Study Leadership Team and may contribute to abstracts, posters, content for scientific meetings. You will work with Lead Clinical Scientists/Medical Directors/Clinical Directors and cross-functional groups to execute the Medical Data Review Plan, data interpretation and contribute to study reporting. You will contribute (with guidance) to Clinical Trial Application (CTA)/Ethics Committee (EC) written interactions, briefing packs, written responses to Health Authority (HA) questions, clinical science data/preparations for HA interactions and clinical data input to regulatory submissions. You will have the opportunity to contribute to exploratory safety analyses and be involved in cross franchise initiatives You will work in a collaborative environment with internal and external stakeholders; you have the ability to work cross functionally with early development stakeholders (specifically in gRED and/or pRED) especially in preclinical sciences, discovery sciences and/or developmental sciences, You have provide the necessary support with governing laws, regulations, guidelines and Roche SOPs on global clinical trial execution is required and some knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation. Who You Are Required You hold a bachelor's Degree focused in Biology, Biomedical Sciences and/or other relevant Life Science areas; Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc). You have 1-2 years of clinical development, industry experience, with demonstrated expertise in both early and late stage R&D drug development, including discovery sciences. You have a good understanding of the multidisciplinary functions involved in drug development; including ICF, CST and Safety Data Review activities. Preferred You have the ability to independently carry out the majority of the study conduct responsibilities; you have worked across various therapeutic areas in drug development You have demonstrated experience with protocol review and assessment. You have proven ability to work effectively and efficiently within cross-functional teams, e.g. Study Leadership Team/CSL with therapeutic area-relevant clinical trial experience or clear ability to adapt with transferable skills You have strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location San Francisco, CA is $124,800.00 - $205,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
$124.8k-205k yearly Auto-Apply 2d ago
Clinical Research Associate
Kumquat Biosciences Inc. 3.9
San Diego, CA jobs
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Kumquat Biosciences. As a CRA, you will play a key role in the coordination and execution of global oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: * Support the study lead(s) in day-to-day operational management of one or more clinical trials. * Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements. * May manage one or more key study vendors including central lab, IRT/RTSM, or CRO. * Monitor and track study progress, patient recruitment, and data collection at investigational sites. * Review and verify the accuracy, completeness, and quality of clinical trial data. * Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files. * Collaborate with investigators, study coordinators, and other site staff to provide guidance and support. * Identify and escalate any issues or deviations from the study plan to the appropriate parties. * Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions. * Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Requirements * Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. * 2+ years of clinical operations experience or related drug development. * Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. * Excellent organizational and time-management skills. * Strong communication and interpersonal skills. * Ability to work independently and as part of a cross-functional team. * Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. * Willingness to travel to investigational sites as required. * Familiarity with early phase clinical trial protocols and procedures a plus. * Prior vendor management experience a plus. Salary Description: $93k - $124k Yearly Salary Description $93k - $124k
$93k-124k yearly 16d ago
Clinical Research Associate
Kumquat Biosciences Inc. 3.9
San Diego, CA jobs
Job DescriptionDescription: We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Kumquat Biosciences. As a CRA, you will play a key role in the coordination and execution of global oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: · Support the study lead(s) in day-to-day operational management of one or more clinical trials. · Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements. · May manage one or more key study vendors including central lab, IRT/RTSM, or CRO. · Monitor and track study progress, patient recruitment, and data collection at investigational sites. · Review and verify the accuracy, completeness, and quality of clinical trial data. · Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files. · Collaborate with investigators, study coordinators, and other site staff to provide guidance and support. · Identify and escalate any issues or deviations from the study plan to the appropriate parties. · Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions. · Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Requirements: · Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. · 2+ years of clinical operations experience or related drug development. · Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. · Excellent organizational and time-management skills. · Strong communication and interpersonal skills. · Ability to work independently and as part of a cross-functional team. · Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. · Willingness to travel to investigational sites as required. · Familiarity with early phase clinical trial protocols and procedures a plus. · Prior vendor management experience a plus. Salary Description: $93k - $124k Yearly
$93k-124k yearly 15d ago
Clinical Research Associate
Kumquat Biosciences 3.9
San Diego, CA jobs
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Kumquat Biosciences. As a CRA, you will play a key role in the coordination and execution of global oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: · Support the study lead(s) in day-to-day operational management of one or more clinical trials. · Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements. · May manage one or more key study vendors including central lab, IRT/RTSM, or CRO. · Monitor and track study progress, patient recruitment, and data collection at investigational sites. · Review and verify the accuracy, completeness, and quality of clinical trial data. · Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files. · Collaborate with investigators, study coordinators, and other site staff to provide guidance and support. · Identify and escalate any issues or deviations from the study plan to the appropriate parties. · Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions. · Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Requirements · Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. · 2+ years of clinical operations experience or related drug development. · Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. · Excellent organizational and time-management skills. · Strong communication and interpersonal skills. · Ability to work independently and as part of a cross-functional team. · Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. · Willingness to travel to investigational sites as required. · Familiarity with early phase clinical trial protocols and procedures a plus. · Prior vendor management experience a plus. Salary Description: $93k - $124k Yearly Salary Description $93k - $124k
$93k-124k yearly 16d ago
Clinical Research Associate - Palo Alto, CA (HQ)
Sciton 4.5
Palo Alto, CA jobs
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Clinical Research Associate (CRA) The Clinical Research Associate (CRA) will be responsible for managing multiple aspects of clinical trials. This includes assisting with study start-up, ongoing monitoring, data management, and analysis, as well as ensuring compliance with study protocols and ethical standards. This role reports to the Senior Clinical Research Leader. Key Responsibilities: Prepare essential clinical study documents, including informed consent forms and source documents. Assist with the initiation and set-up of clinical trial sites. Develop and maintain comprehensive documentation required throughout the clinical study lifecycle. Conduct regular site monitoring visits to oversee data collection and ensure strict adherence to study protocols. Review and validate collected data for accuracy, completeness, and alignment with source documentation. Maintain up-to-date study files, including all regulatory and study-specific documentation. Ensure compliance with regulatory standards, including GCP, ICH guidelines, and IRB requirements. Qualifications: Bachelor's degree in a relevant clinical research or life sciences field. Minimum 3-5 years' experience in clinical research, with a strong background in site monitoring. Demonstrated experience in clinical trial design and data analysis. Skills & Competencies: Proven ability to work independently with a high level of initiative. Collaborative team player with flexibility to adapt in dynamic or uncertain environments; willingness to travel as needed. Excellent written and verbal communication skills. Strong ability to critically review scientific literature and interpret clinical evidence. Advanced analytical and problem-solving abilities. Compensation and Benefits The salary range for this position is $80-$100k. In addition to a competitive market-based salary, Sciton provides an opportunity to participate in equity/stock incentive programs, a profit-sharing bonus, and a comprehensive benefits package, including 401(K) with matching. FULL-TIME/PART-TIME Full-Time POSITION Clinical Research Associate LOCATION Palo Alto, CA (HQ) ABOUT THE ORGANIZATION SCITON is an industry leader and manufacturer of medical aesthetic lasers and light source technologies. With a vision to improve people's lives, our top-tier devices are built to order with integrity by pioneering, customer-focused, and results-driven individuals. At the heart of it, innovation is a fundamental cornerstone of our culture. We strongly believe that new ideas can come from anyone, anywhere, at any time and embrace an open-door culture that welcomes and fosters individuals who are creative, driven, passionate, and willing to take the lead with us. Join us for an opportunity to grow and make an impact. Life at Sciton: At Sciton, people matter. We are more than a company; we are a family, which is why we give all our employees: The support, recognition, and room to grow their careers within Sciton. Empowerment to develop their creative genius and encouragement to be lifelong learners. Incentives for creativity and innovation across the organization.
$80k-100k yearly 60d+ ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Irvine, CA jobs
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
$54.4k-80.1k yearly Auto-Apply 24d ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Irvine, CA jobs
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
$54.4k-80.1k yearly Auto-Apply 22d ago
Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab
Cedars Sinai 4.8
Los Angeles, CA jobs
The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Join our team and use your experience with an organization known nationally for excellence in research! The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Primary Duties and Responsibilities * Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. * Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. * Completes Case Report Forms (CRFs) * Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. * Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines * Assists with clinical trial budgets and patient research billing * Responsible for sample preparation and shipping and maintenance of study supplies and kits. * Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law * May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Qualifications Educational Requirements: * High school diploma/GED required * Bachelor's degree in Science, Sociology or related degree preferred Licenses: * CPT- Phlebotomy Certification license required Experience: 1 year clinical research experience preferred Physical Demands: * Able to perform moderate lifting. * Able to sit, stand and walk for prolonged periods of time. * Able to read papers and online documents. * Able to operate standard office equipment. * Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Req ID : 9809 Working Title : Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $19.50 - $32.86
$19.5-32.9 hourly 44d ago
Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab
Cedars-Sinai 4.8
Los Angeles, CA jobs
The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. **Join our team and use your experience with an organization known nationally for excellence in research!** The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. **Primary Duties and Responsibilities** + Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. + Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. + Completes Case Report Forms (CRFs) + Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. + Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines + Assists with clinical trial budgets and patient research billing + Responsible for sample preparation and shipping and maintenance of study supplies and kits. + Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law + May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. **Qualifications** **Educational Requirements:** - High school diploma/GED required - Bachelor's degree in Science, Sociology or related degree preferred **Licenses:** - CPT- Phlebotomy Certification license required **Experience:** 1 year clinical research experience preferred **Physical Demands:** - Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. **Req ID** : 9809 **Working Title** : Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab **Department** : Heart Institute **Business Entity** : Cedars-Sinai Medical Center **Job Category** : Academic / Research **Job Specialty** : Research Studies/ Clin Trial **Overtime Status** : NONEXEMPT **Primary Shift** : Day **Shift Duration** : 8 hour **Base Pay** : $19.50 - $32.86 Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.
$19.5-32.9 hourly 60d+ ago
Research Assistant - Clinical Research Cancer -Hoag Newport Beach
Hoag 4.8
Newport Beach, CA jobs
Key Qualifications: Research experience is a plus Oncology experience is a plus Medical terminology experience is required. Data entry experience required. Primary Duties and Responsibilities The Research Assistant will serve as the first point of contact, both in person and for incoming calls to the department. This person will provide administrative support, playing an important role in the overall success of the department. Responsibilities include answering telephone calls and assisting callers, coordinating appointments. Monitor and/or order office supplies as needed as well as keeping supplies organized. Scheduling equipment repair and service. HIRE & CLINICAL RESEARCH: Assists Regulatory and Financial specialists with review of confidential disclosure agreements. Track IRB Renewals, send reminders, and assist with IRB reviews. Obtain signatures for budgets, MCA's and professional service agreements. Education and Experience High School Graduate or equivalent Working knowledge of Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint, plus healthcare database systems Bachelor's degree in healthcare-related field preferred Minimum 2- 4 years' experience required. Three (3) years' administrative support experience in a corporate environment preferred May distribute mail and process incoming/outgoing mail. Schedules various room reservations for meetings and maintains room calendars as requested. Assists in the development of policies and procedures and departmental forms. Maintains up to date unit specific data, logs, and runs reports for management. May support ongoing Programs or special Projects. Acts as Hoag Ambassador to patients, visitors, staff, physicians, vendors and the community. Performs other duties as assigned.
$44k-61k yearly est. Auto-Apply 23d ago
Clinical Research Associate II - Smidt Heart Institute (Dr. Makkar)
Cedars-Sinai Medical Center 4.8
Los Angeles, CA jobs
Grow your career at Cedars-Sinai! The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Join our team and use your skills with an organization known nationally for excellence in research! Job Responsibilities The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties and Responsibilities • Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study. • Evaluates and abstracts clinical research data from source documents. • Completes Case Report Forms (CRFs). • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. • Provides supervised contact with research participants or contact for long term follow-up research participants only. • Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines • Assists with clinical trial budgets. • Schedules research participants for research visits and research procedures. • Responsible for sample preparation and shipping and maintenance of study supplies and kits. • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. • Participates in required training and education programs. May be involved in training and education of other Clinical Research Associates. • Serves as the point of contact for external sponsors for select trials. • Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives. • Participates in centralized activities such as auditing, Standard Operating Procedure development, etc. • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications Qualifications Educational Requirements: - Highschool diploma required - Bachelor's degree preferred Licenses:- SOCRA or ACRP certification preferred Experience: - 1 year clinical research related experience required Physical Demands: - Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
$41k-54k yearly est. Auto-Apply 60d+ ago
Study Coordinator
Sarah Cannon Research Institute 3.6
Denver, CO jobs
It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process Pay range $29.33/hr - $35.00/hr About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
$29.3-35 hourly Auto-Apply 60d+ ago
Assistant Clinical Research Coordinator
Om Research 4.4
Camarillo, CA jobs
The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.
$48k-66k yearly est. 60d+ ago
Assistant Clinical Research Coordinator
Om Research LLC 4.4
Camarillo, CA jobs
Job Description The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.
$48k-66k yearly est. 24d ago
Clinical Research Assistant
Intermountain Health 3.9
Denver, CO jobs
The purpose of this position is to assist in duties and activities associated with supporting clinical research and research studies at Intermountain Healthcare. A key responsibility of this position is to provide support to clinical research coordinators, clinical investigators, physicians, nurses, department managers and other staff. **Essential Functions** The following will be done under direct supervision: + **Sample Management:** Assist in the collection, preparation, shipment, and evaluation of laboratory samples, and when applicable safely operate laboratory equipment in compliance with trainings and regulations. + **Data Entry & Documentation:** Provide data entry and appropriate documentation into Intermountain departmental and study-related external programs. Maintains research records in accordance with policies and regulations. Archives research study records at study closure. + **Scheduling & Inventory Management** : Schedule monitoring and vendor visits and manage study kit inventory. + **Prescreening Activities:** Assist with prescreening activities by reviewing medical records of potential participants. + **Data Management:** Collect, input, and maintain data in Intermountain and external databases. + **Procedure Preparation** : Prepare for and organize upcoming research procedures according to designated study protocols. May support regulatory team of designated area as requested. + **Consent Assistance:** Assist with obtaining research consent for patients on registry, observational, biospecimen, or other low-risk types of studies. Complies with training on techniques and processes, FDA Good Clinical Practice, and departmental SOPs to ensure compliance with Intermountain policy and procedure, research sponsors and federal rules and regulations. + **Collaboration & Other Duties:** Interact closely with coworkers, medical staff, and patients, and perform other duties as assigned. **Skills** + Teamwork + Organization + Prioritization + Adaptability + Continuous learner + Critical thinking + Self-motivation + Written and Verbal Communication + Time Management + Research **Minimum Qualifications** + Experience using basic computer programs including Microsoft word processing, database, spreadsheet applications and e-mail. **Preferred Qualifications** + Prior experience in a research, academic or healthcare setting. + Prior experience working with laboratory protocol, systems and documentation techniques. **Physical Requirements:** **Location:** Intermountain Health Lutheran Hospital, Saint Joseph Hospital **Work City:** Denver **Work State:** Colorado **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $19.31 - $26.22 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.
$30k-39k yearly est. 2d ago