Post job

Clinical research associate jobs in Vista, CA - 137 jobs

All
Clinical Research Associate
Clinical Research Assistant
Clinical Research Coordinator
Clinical Research Scientist
Clinical Trial Coordinator
Study Coordinator
Senior Clinical Research Coordinator
  • Clinical Research Associate (In House)

    Kumquat Biosciences Inc. 3.9company rating

    Clinical research associate job in San Diego, CA

    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 26d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Clinical Research Associate - Oncology - Los Angeles

    Icon Clinical Research

    Clinical research associate job in San Diego, CA

    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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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. Salary range: $91,336.00-$114,170.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $91.3k-114.2k yearly 7d ago
  • Clinical Research Associate (Start Up) Multi TA - Irvine, CA

    Ire

    Clinical research associate job in Irvine, CA

    Clinical Research Associate (SOAR) Multi TA - Texas 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 will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Irvine, California area, near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. 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. Salary Range $91,336.00-$114,170.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply
    $91.3k-114.2k yearly Auto-Apply 4d ago
  • Clinical Research Associate - Oncology - Los Angeles

    Icon Central Laboratories

    Clinical research associate job in San Diego, CA

    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 Are you a current ICON Employee? Please click here to apply: link
    $63k-99k yearly est. Auto-Apply 8d ago
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Clinical research associate job in Irvine, CA

    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 60d+ ago
  • Principal Clinical Research Scientist - Surgical Implants Vision

    8427-Janssen Cilag Manufacturing Legal Entity

    Clinical research associate job in Irvine, CA

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America, Milpitas, California, United States of America Job Description: About Vision Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Principal Clinical Research Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses. Purpose: The Principal Clinical Research Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient. You will be responsible for: Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.) Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies Performs other related duties as assigned by management Qualifications An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend. Other: Post-graduate degree or residency is preferred Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required Experience with intraocular lenses is preferred. Strong technical writing ability, such as clinical study protocols, reports and abstracts is required Understanding of biostatistics as applied to study data is required Proficient with computers and software programs is required Ability to travel 10% of the time is required. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-VY1 #LI-Hybrid Required Skills: Preferred Skills: Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management The anticipated base pay range for this position is : $117,000.00 - $201,250.00 For Bay Area: $134,000.00 - $231,150.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year
    $134k-231.2k yearly Auto-Apply 15d ago
  • Principal Clinical Research Scientist - Surgical Implants Vision

    6120-Janssen Scientific Affairs Legal Entity

    Clinical research associate job in Irvine, CA

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America, Milpitas, California, United States of America Job Description: About Vision Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Principal Clinical Research Scientist - Surgical Implants Vision platform. The role is based on either the Irvine, CA or Milpitas, CA campuses. Purpose: The Principal Clinical Research Scientist - Surgical Implants Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient. You will be responsible for: Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.) Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies Performs other related duties as assigned by management Qualifications An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend. Other: Post-graduate degree or residency is preferred Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required Experience with intraocular lenses is preferred. Strong technical writing ability, such as clinical study protocols, reports and abstracts is required Understanding of biostatistics as applied to study data is required Proficient with computers and software programs is required Ability to travel 10% of the time is required. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-VY1 #LI-Hybrid Required Skills: Preferred Skills: Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management The anticipated base pay range for this position is : $117,000.00 - $201,250.00 For Bay Area: $134,000.00 - $231,150.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year
    $134k-231.2k yearly Auto-Apply 15d ago
  • Senior Clinical Research Coordinator (48749)

    Platinum Dermatology Partners 3.8company rating

    Clinical research associate job in San Diego, CA

    Who We Are: Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. We offer general dermatology, cosmetic, medical, plastic surgery, and cancer screening treatments. We have over 120 clinics, over 350 providers, and more than 2100 employees in clinics across Texas, Arizona, California, Nevada, and Florida. We are a rapidly growing company that allows our doctors to focus on providing exceptional care without worrying about the operational side of the business. Our core values focus on collaboration, ownership, respect, excellence, authenticity, and integrity. Our purpose is to empower the practice of exceptional dermatology. Company Conformance Statements: In the performance of their respective tasks and duties, all employees are expected to conform to the following: Perform quality work within deadlines with or without direct supervision. Interact professionally with other employees, customers, and suppliers. Work effectively as a team contributor on all assignments. Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations. Position Purpose: Responsible for performing all administrative aspects of clinical trial research studies based upon the needs and goals of the Research Program. Tasks include, but are not limited to, recruitment, completion of database logs for pre-screens, scheduling, consents, and close-out of study per protocols. Provide support to PI/sub-I as requested. Responsibilities: Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study, including, but not limited to: Subject recruitment, screening, and enrollment Collection of laboratory specimens, informed consent, and other data from the subject. Maintenance of source documents, including CRF (case report form) completion and review for accuracy Participation in site monitoring visits and audits. Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos. Filing and maintenance of all study-related documents. Documents adverse events and notifies the principal investigator and appropriate agencies. Notifies Director, sponsor, and IRB of any serious adverse events. Assist the physician with all procedures, including excisions, injections, laser treatments, wound care, post-op care, and dressing changes. Set up the exam room for the specific procedure as indicated. Provide patient education and literature. Take pre- and post-treatment pictures. Clean pack and sterilize instruments. Assists in cleaning rooms. Monitor the physician's schedule to maintain a timely flow. Ensure studies are conducted according to protocol and in accordance with GCP, ICH, and FDA guidelines. Ensure IRB guideline and SOP compliance. Ensure all study timelines are met, and study folders are kept updated and accurate. Work closely with the physician(s) and medical provider(s) assigned to the study. Oversee, participate, and enter data on time, perform study monitoring in peer-to-peer inter- rated methodology. Enter all data within 2 days of the study visit by the Research Coordinators, and query resolution is performed within 2 days of the query. Random QC monitoring process to be established bythe Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology. Perform other tasks/duties as requested or assigned by PI/sub-I and Director. Must be able to travel to oversee studies in multiple sites as required. Coordinate study schedules with practice personnel. Train other team members on study protocols and visits. Qualifications THIS IS AN ONSITE ROLE LOCATED IN LA JOLLA, CA Education and Experience: Bachelor's Degree required. Health Sciences background preferred. 3 years of prior experience; knowledge of phlebotomy techniques Knowledge of the IRB regulatory submission process, GCPs, and CFRs related to research. Certified Clinical Research Coordinator (CCRC) designation is a plus. Essential Skills and Abilities: Committed to executing exceptional patient service and satisfaction. Ability to support the organization's preferences and priorities. Ability to generate respect and trust from colleagues and leadership. Excellent listening, oral, and written communication skills. Tactful, mature, and able to interact well with diverse personalities. Able to exemplify professional behavior in all aspects of the position. Computer-literate with good keyboarding skills Ability to operate basic office equipment such as a phone, fax, copier, printer, etc. Our competitive benefits package includes the following: Medical, Dental, and Vision insurance Short-term/Long-term disability Life and other voluntary plans 401(k) plan Employee Referral Program Paid Time-Off Company-Paid Holidays Equipment Operated: Standard office equipment, including computers, fax machines, copiers, printers, telephones, etc. Physical Requirements: Must possess manual dexterity to operate office machine,s including computer and calculator; stooping and bending to handle files and supplies; and mobility to complete errands or deliveries. Includes handling of sharps and chemicals. Equal Employment Opportunity: Platinum Dermatology Partners is committed to a policy of equal employment opportunities for applicants and Employees. Employment decisions will comply with all applicable laws prohibiting discrimination in employment, including Title VII of the Civil Rights Act of 1964, The Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Immigration and Nationality Act, the California Fair Employment and Housing Act, and all other applicable state and federal laws. Platinum Dermatology Partners does not permit discrimination of any type against an employee because of any of the following legally protected characteristics: gender, race, color, religion, country of origin, mental disability, physical disability, marital status, gender identity, gender expression, ancestry, genetic information, medical condition, age, sexual orientation, or pregnancy. Please note, that any offer of employment is contingent on the successful completion of pre-employment background checks. No phone calls or agencies, please.
    $61k-93k yearly est. 8d ago
  • Lead Clinical Research Associate

    Usc 4.3company rating

    Clinical research associate job in San Diego, CA

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. Incumbent will lead and provide guidance to clinical monitors for sponsor and investigator initiated clinical research studies. Assists in administration of the consent process, and ensures maintained records are accurate, complete, timely, and compliant. Serves as communications liaison for clinical monitoring and study teams, identifying, resolving, and escalating any issues, as appropriate. Develops and administers clinical trial education and training. Duties will include but are not limited to: Develop and maintain study specific clinical monitoring documentation. Review and contribute to clinical monitoring sections of other study documents. Support development and maintenance of departmental and study SOPs and Work Instructions. Conduct study specific onboarding and training of team members new to the study. Conduct onsite training visits. Represent Clinical Monitoring Team at study specific meetings. Provide study updates on Clinical Monitoring team metrics, site escalations, and other monitoring efforts. Support study start up, maintenance, and close out activities. Participate in interdepartmental meetings to accomplish study milestones. Collaborate with colleagues to address study issues. Expert knowledge and awareness of study manuals to serve as main point of contact for issues identified by study CRAs. Review study status reports and prioritize monitoring activities with study CRAs to meet study milestones. Review Monitor Visit Reports (MVR) and provide feedback to team. Provide oversight of monitor visit compliance with study plans. Escalate problematic behavior and poor performance to CRA Managers as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Review study data in accordance with Clinical Monitoring Plan. Issue and resolves queries in a timely manner. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Conduct onsite and remote monitoring visits for assigned clinical sites. Review Investigator Site Files, study data, perform IP accountability, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Up to 50% travel may be required. Act as main point of contact for assigned clinical sites and respond to communication via study inbox ticketing system in a timely manner. Experience in AD research is preferred. Location: San Diego, CA The annual base salary range for this position is $128,039.82- $161,336.75. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 5 years Minimum Skills: Extensive experience with monitoring of clinical trials and thorough knowledge of medical terminology. Demonstrated experience with the drug development process. Experience with ICH guidelines and Good Clinical Practices (GCP). Proven ability to interpret and apply all relevant federal, state, and local laws, regulations, and policies regarding clinical trials and monitoring. Thorough knowledge of all applicable local and/or national regulations pertaining to clinical trials and monitoring. Preferred Education: Bachelor's degree Preferred Experience: 6 years Preferred Skills: Demonstrated leadership skills. Comprehensive understanding of all aspects of clinical trials. Experience maintaining currency with changing laws, regulations and policies. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $128k-161.3k yearly Auto-Apply 22d ago
  • Undergraduate Studies Coordinator

    Details

    Clinical research associate job in San Diego, CA

    Title & Department: Undergraduate Studies Coordinator; College of Arts and Sciences Posting # 5231 Department Description: As the liberal arts heart of the University of San Diego, the College of Arts and Sciences is filled with students who are versatile and multi-talented. No matter their major, graduates from the college are equipped with transferable skills that benefit them wherever their professional and personal ambitions lead. Founded in 1949, the college has a rich history of providing the core curriculum for every undergraduate USD student, a tradition that continues today. By offering 32 majors, 38 minors, one certificate and three graduate programs, the college is where undergraduate students begin and graduate students refine their paths towards academic excellence and personal achievement. University Description: The University of San Diego, an engaged and contemporary Catholic institution, was founded by the Diocese of San Diego and the Society of the Sacred Heart in 1949. Governed by an independent board of trustees since 1972, USD remains committed to a liberal arts education grounded in the Catholic intellectual tradition and the pursuit of truth, goodness and beauty. Inspired by this centuries old tradition of Catholic higher education, the University welcomes people of all faith traditions and any, or no, religious background. The future success of USD relies on the contributions of those who seek to foster the development of engaged global citizens and an earnest confrontation of humanity's urgent challenges. Detailed Description: Performs detailed, complex coordination, and administrative tasks for the College of Arts and Sciences Dean's Office. Assists the Associate Dean and Assistant Deans of Undergraduate Studies in all aspects. Is responsible for coordination, communication, and marketing activities and events for Learning Communities and Undergraduate Studies. Liaises with other offices on campus to program. Collaborates with the Undergraduate Studies Learning Communities teams to support faculty, students, and staff in the Living Learning (LLC) and Transfer Learning Communities (TLC) programs. Duties and Responsibilities: Undergraduate Studies Coordination: Coordinates, with the Associate Dean, academic onboarding for incoming students in fall and spring. Coordinates and attends meetings with campus partners for first-year and transfer processes throughout the entire year. To support first year experiences for students, coordinates LLC course and housing placements, with Residential Life. Maintains and updates new student advising questionnaires for academic onboarding. Communicates with faculty advisors and professional advisors in the undergraduate units throughout the first-year scheduling process. Creates and maintains manuals for faculty for summer scheduling and LLC advising. Implements plans faculty development training and other events co-sponsored by Undergraduate Studies and Learning Communities offices. Supports Associate Dean with faculty applications and tracking compensation for LC courses and Faculty Integration Coordinators. Supports Associate Dean administratively with curricular and enrollment management, including Census tracking and LC courses. Oversees the input of data from Learning Community Surveys into Qualtrics. Undergraduate Student Support: Maintains the official university database for AP/IB/CLEP scores, including updating tables and websites. Coordinates and administers official notifications to students in mail merges, including highly confidential letters such as disqualification, academic notice / probation, reinstatement, readmittance, and academic integrity letters. Coordinates hearings for grade grievances and academic integrity in collaboration with the Special Assistant to the Associate Dean. Maintains the College's online database (i.e., Maxient) for Academic Integrity. Surveys faculty for the last date of class student attendance for tuition refunds, Faculty Alert Outreach (FAO), wellness-checks, and general academic support. Events and Communication: Plans, implements, and attends Undergraduate Studies, College of Arts and Sciences, and College Academic District events connected to the mission in collaboration with the Associate Dean and Assistant Deans. Schedules meeting for the Associate Dean and Assistant Deans, as needed. Supports the Associate Dean and the Creative Manager who organize the annual New Student Convocation. Administrative Support: Manages communication with other campus and community partners on campus with collaborative efforts in Undergraduate Studies from Advisors, Assistant, and Associate Deans. Review and manage incoming emails from students and forwards to appropriate partner. Coordinates communication efforts for the College Dean's Office. Supports the College of Arts and Sciences Dean's Office, the College Academic District, and the Learning Communities Office as needed. In collaboration with the Dean's office executive assistant, supports the reception process and front desk staffing, as needed. Supervises the training of work study students so that they are familiar with Department, University and the College Dean's Office policies and procedures. Performs other duties as assigned. Special Conditions of Employment: Background check: Successful completion of a pre-employment background check. Degree Verification Requirement: Persons offered employment in this position will be required to provide official education transcripts for degree verification purposes. Job Requirements: Minimum Qualifications: Bachelor's Degree and two years of office work experience OR High School Diploma and four years of office work experience required Above experience must include one year of experience in general office coordination and/or event planning. Preferred Qualifications: Advanced computer skills in Microsoft Office (all applications), website maintenance, and Salesforce preferred. Performance Expectations - Knowledge, Skills and Abilities: Take responsibility for dealing appropriately with problems, exercising independent judgment, and making decisions while engaging with diverse personalities and demographics. Implement skills for organizing and managing concurrent projects, prioritizing workload, and meeting tight deadlines. Excellent professional written, verbal, proofreading, and communication skills. Develop and use empathetic listening skills, communicate with clarity and maintain an attitude that conveys respect, assistance, honesty and resourcefulness. Cooperate as a team to support the mission of Undergraduate Studies and the College of Arts and Sciences Dean's Office. Demonstrate flexibility and versatility to respond to evolving work situations. Establish and maintain strong working relationships with colleagues, staff, administrators, students, and the general public. Knowledge of and ability to learn multiple software platforms--SalesForce, Cascade, Banner, Excel, project management software, MySanDiego portal, Qualtrics, Maxient. Thorough knowledge of general office practices and procedures. Posting Salary: $26.00 - $33.00 per hour; Excellent Benefits The University of San Diego offers a very competitive benefits package including; medical, dental, vision, a retirement contribution given to you by the University, and access to on-campus Fitness Centers. Please visit the benefits section of our website to view all of the perks and benefits that USD has to offer. USD: Human Resources: Benefits The salary range provided in this posting reflects what we reasonably expect to pay for this position. Actual compensation offered or earned is dependent on experience, education and other factors including departmental budget. Special Application Instructions: Resume Required, Cover Letter Preferred Click the 'Apply Now' button to complete our online application and, for full consideration, please upload a resume to your application profile for the hiring managers' review. You are also strongly recommended to upload a cover letter to your application profile for the hiring managers' review. If you have any questions or difficulties please contact the Employment Services Team at *****************. Additional Details: Hours: 37.5 hours per week Closing date: Open until filled Note: External job postings will be up for at least three days. After that time, applications will be reviewed by the hiring manager/committee throughout the posting period. A candidate may be selected at any time which could then close this posting on a date earlier than listed. The University of San Diego is a smoking and tobacco-free campus. For more information, visit ***************************
    $26-33 hourly Easy Apply 60d+ ago
  • Clinical Research Coordinator II (Huntington Beach, CA)

    Care Access 4.3company rating

    Clinical research associate job in Irvine, CA

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Duties include but not limited to: Ability to understand and follow institutional SOPs. Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Assist with planning and creation of appropriate recruitment materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Attend Investigator meetings as required. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Assist in the creation and review of source documents. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Patient Coordination Prescreen study candidates Obtain informed consent per Care Access Research SOP Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Bilingual in Spanish-preferred How We Work Together Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Huntington Beach, CA clinic. Travel: Regularly planned travel within the region will be required as part of the role. Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly Auto-Apply 5d ago
  • Clinical Research Assistant

    Flourish Research

    Clinical research associate job in Murrieta, CA

    Job Description Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Clinical Research Assistants at our Murrieta site location. This is one of our three oncology research sites in the Greater Los Angeles area. These locations are formerly Valkyrie Clinical Trials - we are proud to welcome Valkyrie Clinical Trials to the Flourish Research network! The Clinical Research Assistant supports clinical research studies under the supervision of the Site Director or Clinical Research Coordinator. This role assists with clinic operations and study procedures across all phases of research, ensuring accurate data collection and compliance with GCP, IRB, and sponsor protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Location: 25405 Hancock Ave, Suite 110, Murrieta, CA 92562 Compensation: $20 - $32/hr depending on experience Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES Support CRCs and site staff with protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc. Document assessments and study data per regs/GCP Obtain and document informed consent following federal regulations and IRB guidelines Support patient recruitment efforts and scheduling to meet enrollment goals Maintain accurate source documentation and complete case report forms (CRFs) Report adverse events to supervisors or investigators as needed Help manage study supplies, lab kits, and other trial materials Maintain confidentiality and follow all applicable compliance and ethical standards Communicate effectively with research team members and document relevant study communications Represent Flourish Research professionally in all interactions Perform additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred, but not required Oncology clinical research experience preferred Minimum of two years of clinical research experience Clinical skills preferred: vital signs, EKG/ECG, phlebotomy, and injections Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Powered by JazzHR ei SnJaVCB8
    $20-32 hourly 13d ago
  • Clinical Research Assistant / Medical Assistant

    Headlands Research

    Clinical research associate job in San Diego, CA

    At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees: A range of PPO and HMO medical plans PPO and HMO dental plans Vision coverage, long term disability plan, and life/AD&D coverage 401k plan Paid holidays and paid time off A welcoming work environment We're looking for a bright, talented new team member to be a part of our story. Check out this current opening and if you think you may be a fit for the role, please apply. The Role Artemis is looking for a Research Assistant to assist coordinators in clinical research protocols. This individual will work directly with the coordinators, investigators, and other research staff to ensure protocol visits are being completed in accordance with protocol guidelines. Position Type: Full Time Pay Range : $23 - $27/hr Location: San Diego-no remote work Travel: 0% Work Schedule: Monday & Thursday - 8:30am-5pm / Tuesday, Wednesday, and Friday 7:00am-3:30 pm Responsibilities: Provide services including administration of medications, as directed by the Physicians Ensure safety and welfare of each research participant Assist Site Manager to adequately supply routine medical supplies; reorder supplies through established purchasing procedures Maintain an accurate inventory of medical supplies to ensure services are not compromised due to unforeseen shortages Admit and discharge patients on unit Check vital signs and record daily information in the participant's chart Collect and prepare laboratory specimens Perform basic laboratory tests to include urine pregnancy test and urine drug tests Perform lab draws Perform ECGs Maintain detailed and accurate documentation related to research participants Prepare daily meals and perform light housekeeping duties Provide status updates and communicate with Physicians and Clinical Research Coordinators related to research participants Requirements: Certified Medical Assistant in California Current, valid California Phlebotomy License preferred Minimum of one year of experience managing a lab, ordering, and inventory Minimum 1 year experience in medical field or clinical research Intermediate to advanced computer and phone skills Bilingual in English/Spanish is a plus California Pay Range$23-$27 USD
    $23-27 hourly Auto-Apply 8d ago
  • Clinical Research Coordinator I

    Irvine Clinical Research

    Clinical research associate job in Irvine, CA

    Irvine Clinical Research, a research site specializing in clinical trials of Alzheimer's Disease, is seeking applicants for a Clinical Research Coordinator I. The CRC will work under close supervision of our doctors and a research manager as a coordinator on Phase II/III clinical trials in Neurology and Psychiatry.Job Duties Coordinate the day-to-day clinical operations of a clinical research study Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Recruit, prescreen, and screen potential study participants Conduct diagnostic, efficacy, and safety assessments as needed Job Requirements Interest in working with persons with neurological or psychiatric indications such as Mild Cognitive Impairment, Early Alzheimer's Disease, or Depression Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with computerized systems A command of professional spoken and written English Bachelor's degree or higher Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine. The starting salary for this position is $25 per hour (approximately $52k per year). Higher salary is negotiable with candidates who possess relevant degrees in addition to their bachelor's degree. The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.
    $52k yearly Auto-Apply 60d+ ago
  • Contract Clinical Research Assistant (3 to 6 months)

    Reva Medical

    Clinical research associate job in San Diego, CA

    (3-6 Months)***** Summary of Essential Duties and Responsibilities The primary function in this position will be to provide departmental administrative support in the area of Clinical Affairs, including: Perform quality checks, uploads and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies. Generate reports of missing documents and upcoming expiration dates. Communicate with sites and/or study team to obtain required documents. Ensure the TMF is audit-ready in support of regulatory filings. Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner. Assist in providing feedback to sites as needed. Obtain safety-related source documents from clinical sites in preparation for Clinical Event Committee and Data Safety Monitoring Board meeting packages. Work with translation vendors as needed. Track device inventory and prepare shipments to sites, ensuring device integrity is maintained (i.e., temperature control and expiration dates). Process returned/expired devices. Assist with the distribution and tracking of clinical study supplies to Contract Research Organizations (CROs) and clinical centers (e.g. study binders, case report form worksheets, study devices and misc. materials) Interface with CROs to obtain study-related documentation and follow up on action items Assist with site invoicing and payment tracking Assist with organization and filing of study related materials Assist in the organization and execution of Investigator meetings Assist in processing and tracking of study related costs Provide general administrative support as needed Education and/or Experience Undergraduate degree 2-3 years of relevant clinical trial experience Required Knowledge/Skills Minimum of 1-2 years of clinical study electronic Trial Master File experience Proficient with basic computer programs such as Microsoft Word, Excel PowerPoint and Adobe Acrobat Detail oriented in document review and error checking Effective communication skills Desired Knowledge/Skills Minimum of 1-2 years of Sponsor or CRO experience Working knowledge of CDISC TMF Reference Model Physical Demands/Working Environment 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 frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.
    $38k-54k yearly est. 9d ago
  • Clinical Research Associate - Oncology - Los Angeles

    Ire

    Clinical research associate job in San Diego, CA

    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 Are you a current ICON Employee? Please click here to apply: link
    $63k-99k yearly est. Auto-Apply 8d ago
  • Clinical Trial Neuropathology & Data Sharing Coordinator

    Usc 4.3company rating

    Clinical research associate job in San Diego, CA

    The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials. The Clinical Trial Neuropathology and Data Sharing Coordinator will work under the ACTC Program Administrator to support clinical sites in their efforts to establish post-mortem brain donation procedures for multi-site clinical trials for Alzheimer's Disease. This position will also lead implementation working groups for the data and sample sharing initiatives. The incumbent will be responsible for a wide range of work assignments and must be well organized, able to manage several projects at the same time; functioning well in both a project lead role as well as part of a team in a fast-paced environment. Ideal candidate must be a self-starter, have high attention to detail, able to think critically, and effectively problem solve. Must be able to work efficiently independently and be an effective collaborator in a team environment. The ideal candidate will have experience with clinical trials, brain donation procedures, data sharing, development and implementation of research protocols. Prior comparable experience that relates to the following position goals is also desirable. • Assist clinical research sites in establishing sustainable practices for participant education and follow up, as well as establishing logistical arrangements to facilitate postmortem brain donation. • Working with the scientific Leads of ACTC Neuropathology Unit, facilitate development of Master and study-specific protocols and procedures for tissue collection, analysis, banking and sharing. • Lead implementation working groups for the data and sample sharing initiatives for ACTC clinical trials. The hourly rate range for this position is $30.14 - $38.71.When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Skills: Directly related project or administrative experience. Preferred Education: Master's degree Preferred Experience: 3 years USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at **************, or by email at *************. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: *************************************************************
    $30.1-38.7 hourly Auto-Apply 41d ago
  • Clinical Research Coordinator (48718)

    Platinum Dermatology Partners 3.8company rating

    Clinical research associate job in San Diego, CA

    Who We Are: Platinum Dermatology Partners is a network of high-quality dermatology clinics that focus on collaborative and innovative ideas to drive growth. We offer general dermatology, cosmetic, medical, plastic surgery, and cancer screening treatments. We have over 145 clinics, over 350 providers, and more than 2300 employees in clinics across Texas, Arizona, California, Nevada, and Florida. We are a rapidly growing company that allows our doctors to focus on providing exceptional care without worrying about the operational side of the business. Our core values focus on collaboration, ownership, respect, excellence, authenticity, and integrity. Our purpose is to empower the practice of exceptional dermatology. Company Conformance Statements: In the performance of their respective tasks and duties, all employees are expected to conform to the following: Perform quality work within deadlines with or without direct supervision. Interact professionally with other employees, customers, and suppliers. Work effectively as a team contributor on all assignments. Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations. Job Summary: This role is responsible for perfoming all administrative aspects of clinical trial research studies based upon needs and goals of the Research Program. Tasks include, but are not limited to, recruitment completion of database logs for pre-screens, scheduling, consents, and close out of study per protocols. Provide support to PI/sub-I as requested at multiple clinics Responsibilites: Perform all research coordinator duties required to adhere to FDA guidelines and study protocols, and facilitate the daily clinical trial activities required to conduct the study including, but not limited to: Subject recruitment, screening and enrollment Collection of laboratory specimens, informed consent and other data from subject. Maintenance of source documents including CRF (case report form) completion and review for accuracy Participation in site monitoring visits and audits. Documentation of laboratory and histological procedures. Ensure accurate labeling of slide photos. Filing and maintenance of all study related documents. Documents adverse events and notifies principal investigator and appropriate agencies. Notifies Director, sponsor and IRB of any serious adverse events. Assist physician with all procedures to include excisions, injections, laser treatments, wound care, post-op care and dressing changes. Set up exam room for specific procedure as indicated. Provide patient education and literature. Take pre- and post-treatment pictures. Clean pack and sterilize instruments. Assists in cleaning rooms. Monitor physician's schedule to maintain timely flow. Ensure studies are conducted according to protocol and in accordance with GCP, ICH and FDA guidelines. Ensure IRB guideline and SOP compliance. Ensure all study timelines are met and study folders are kept updated and accurate. Work closely with the physician(s) and medical provider(s) assigned to the study. Oversee, participate and enter in timely manner data entry, perform study monitoring in peer-to-peer inter- rated methodology. Enter all data within 2 days of study visit by Research Coordinators and query resolution performed within 2 days of query. Random QC monitoring process to be established by Director and conducted by Research Coordinators in peer-to-peer inter-rated methodology. Perform other tasks/duties as requested or assigned by PI/sub-I and Director. Must be able to travel to oversee studies in multiple sites as required. Coordinate study schedules with practice personnel. Train other team members on study protocols and visits. Qualifications THIS IS AN ONSITE/IN CLINIC ROLE LOCATED IN LA JOLLA, CA Education: Bachelor's Degree required. Health Sciences background preferred. 3 years prior experience; knowledge of phlebotomy techniques Knowledge of IRB regulatory submission process, GCPs, and CFR related to research. Certified Clinical Research Coordinator (CCRC) designation a plus. Essential Skills and Abilities: Committed to executing exceptional patient service and satisfaction. Ability to support the organization's preferences and priorities. Ability to generate respect and trust from colleagues and leadership. Excellent listening, oral and written communication skills. Tactful, mature and able to interact well with diverse personalities. Able to exemplify professional behavior in all aspects of position. Computer literate with good keyboarding skills Ability to operate basic office equipment such as a phone, fax, copier, printer etc. Must have a valid driver's license. Our competitive benefits package includes the following: Medical, Dental, and Vision insurance Short-term/Long-term disability Life and other voluntary plans 401(k) plan Employee Referral Program Paid Time-Off Company-Paid Holidays Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc. Physical Requirements: Must possess manual dexterity to operate office machines including computer and calculator; stooping and bending to handle files and supplies; and mobility to complete errands or deliveries. Includes handling of sharps and chemicals. Equal Employment Opportunity: Platinum Dermatology Partners is committed to a policy of equal employment opportunities for applicants and Employees. Employment decisions will comply with all applicable laws prohibiting discrimination in employment, including Title VII of the Civil Rights Act of 1964, The Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Immigration and Nationality Act, the California Fair Employment and Housing Act, and all other applicable state and federal laws. Platinum Dermatology Partners does not permit discrimination of any type against an employee because of any of the following legally protected characteristics: gender, race, color, religion, country of origin, mental disability, physical disability, marital status, gender identity, gender expression, ancestry, genetic information, medical condition, age, sexual orientation, or pregnancy. Please note, that any offer of employment is contingent on the successful completion of pre-employment background checks. No phone calls or agencies, please.
    $49k-70k yearly est. 8d ago
  • Clinical Research Assistant

    Flourish Research

    Clinical research associate job in Murrieta, CA

    Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Clinical Research Assistants at our Murrieta site location. This is one of our three oncology research sites in the Greater Los Angeles area. These locations are formerly Valkyrie Clinical Trials - we are proud to welcome Valkyrie Clinical Trials to the Flourish Research network! The Clinical Research Assistant supports clinical research studies under the supervision of the Site Director or Clinical Research Coordinator. This role assists with clinic operations and study procedures across all phases of research, ensuring accurate data collection and compliance with GCP, IRB, and sponsor protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Location: 25405 Hancock Ave, Suite 110, Murrieta, CA 92562 Compensation: $20 - $32/hr depending on experience Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES Support CRCs and site staff with protocol-specified patient visits and procedures, which may include, but not limited to, phlebotomy, IVs, injections, vital signs, ECG/EKG, etc. Document assessments and study data per regs/GCP Obtain and document informed consent following federal regulations and IRB guidelines Support patient recruitment efforts and scheduling to meet enrollment goals Maintain accurate source documentation and complete case report forms (CRFs) Report adverse events to supervisors or investigators as needed Help manage study supplies, lab kits, and other trial materials Maintain confidentiality and follow all applicable compliance and ethical standards Communicate effectively with research team members and document relevant study communications Represent Flourish Research professionally in all interactions Perform additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred, but not required Oncology clinical research experience preferred Minimum of two years of clinical research experience Clinical skills preferred: vital signs, EKG/ECG, phlebotomy, and injections Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
    $20-32 hourly Auto-Apply 13d ago
  • Contract Clinical Research Assistant (3 to 6 months)

    Reva Medical LLC

    Clinical research associate job in San Diego, CA

    Job Description (3-6 Months)***** Summary of Essential Duties and Responsibilities The primary function in this position will be to provide departmental administrative support in the area of Clinical Affairs, including: Perform quality checks, uploads and tracking of required regulatory documents to populate the electronic Trial Master File (TMF) for designated studies. Generate reports of missing documents and upcoming expiration dates. Communicate with sites and/or study team to obtain required documents. Ensure the TMF is audit-ready in support of regulatory filings. Track and ensure study-related images are obtained from sites and provided to Core Labs for analysis in a timely manner. Assist in providing feedback to sites as needed. Obtain safety-related source documents from clinical sites in preparation for Clinical Event Committee and Data Safety Monitoring Board meeting packages. Work with translation vendors as needed. Track device inventory and prepare shipments to sites, ensuring device integrity is maintained (i.e., temperature control and expiration dates). Process returned/expired devices. Assist with the distribution and tracking of clinical study supplies to Contract Research Organizations (CROs) and clinical centers (e.g. study binders, case report form worksheets, study devices and misc. materials) Interface with CROs to obtain study-related documentation and follow up on action items Assist with site invoicing and payment tracking Assist with organization and filing of study related materials Assist in the organization and execution of Investigator meetings Assist in processing and tracking of study related costs Provide general administrative support as needed Education and/or Experience Undergraduate degree 2-3 years of relevant clinical trial experience Required Knowledge/Skills Minimum of 1-2 years of clinical study electronic Trial Master File experience Proficient with basic computer programs such as Microsoft Word, Excel PowerPoint and Adobe Acrobat Detail oriented in document review and error checking Effective communication skills Desired Knowledge/Skills Minimum of 1-2 years of Sponsor or CRO experience Working knowledge of CDISC TMF Reference Model Physical Demands/Working Environment 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 frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.
    $38k-54k yearly est. 13d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Vista, CA?

The average clinical research associate in Vista, CA earns between $52,000 and $123,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Vista, CA

$80,000

What are the biggest employers of Clinical Research Associates in Vista, CA?

The biggest employers of Clinical Research Associates in Vista, CA are:
  1. QuintilesIMS
Job type you want
Full Time
Part Time
Internship
Temporary