Clinical research associate jobs in Paramount, CA

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

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

Required upon hire: ACRP or SOCRA certification, or other Clinical Research Certification Education: Bachelor's Degree Required Master's Degree Preferred Experience: - 7 years of Clinical research experience REQUIRED - 5 years in management or supervision of clinical trials REQUIRED. - 5 years Experience in clinical research finance REQUIRED - Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways REQUIRED - Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research REQUIRED. - Experience with working with Pharmaceutical and FDA agency representatives REQUIRED. Summary Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff. Responsible for oversight of the day to day operations of the clinical research finance team. Responsibilities include compliance with regulations and assure good communication between the various ministries, stakeholders and leadership. Assists in developing, implementing and maintaining policies and procedures. Assists in providing on-going formal and informal training for research staff. Responsible for overseeing the development of research contracting and budgeting standards. Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law. Lead the development and implementation of study builds in the clinical trial management system (CTMS). Skills Needed: • Computer literate to include advanced level proficiency in Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail and Internet. • Thorough knowledge and understanding of HIPPA, GCP and ICH regulations, clinical trial monitoring, and regulatory compliance. • Extensive Knowledge of DHHS, FDA, NCI, NIH, OHRP and other relevant regulations concerning research and compliance. • Knowledgeable of principles of accounting and contract law affecting clinical trials. • Ability to successfully budget and negotiate industry contracts for sponsored clinical trials. • Highly organized and attentive to details, problem solving abilities and ability to work with minimal supervision. • Highly motivated and able to take initiative. • Ability to prioritize, organize, plan, and implement as well as handle multiple projects/problems simultaneously within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress, challenges and results effectively. • Knowledge of operations, including human resource, budget management and work flow planning. • Ability to plan, chair, document and follow-up on administrative and related meetings. • Ability to work independently and with minimal supervision. • Ability to be flexible, multi task and switch priorities as well as work comfortably in a deadline driven environment. • Communicates well with physicians, patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information. • Interacts favorably with people by phone and in person, and work effectively as part of a team. • Demonstrate communication, leadership, and team building skills; evidence of this should includes dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others. • Excellent written/verbal communication skills to effectively interact with all levels of management, departments, and users.

Patient Care & Recruitment: Screen, enroll, and educate patients about trial protocols, manage appointments, and collect follow-up data. Protocol Adherence: Ensure all study activities (drug administration, data collection) strictly follow the study protocol and Good Clinical Practice (GCP). Data Management: Collect, enter, and manage accurate study data; communicate with labs about results. Regulatory Compliance: Work with Institutional Review Boards (IRBs) and sponsors to maintain compliance with laws and regulations. Team Collaboration: Work with doctors, nurses, and other staff; train new personnel; and communicate with sponsors and regulatory bodies. Administrative Tasks: Manage study budgets, supplies, and development of recruitment materials.

Don Lee Farms creates premium burgers, bowls, and tacos for America's top markets. As a multigenerational family-run company, we specialize in delivering delicious and convenient food options. Our products can be found at leading retailers like Trader Joe's, Costco, Walmart, and Sam's Club. Whether under the Don Lee Farms brand or other store labels, we make mealtimes hassle-free with our quality foods. About the Role We are seeking a R&D & Sales Project Coordinator to support our Sales and R&D teams in moving projects forward, preparing for customer meetings, and ensuring smooth execution of product launches. This role is ideal for someone early in their career who thrives in a fast-paced environment, enjoys problem-solving, and wants a clear path to grow into sales or account management at Don Lee Farms. This is an in-person role. Key Responsibilities Work closely with the Sales and R&D teams to advance up to 100 projects at a time from concept to launch. Enter and maintain accurate product and project data in customer portals. Coordinate across departments (R&D, operations, quality) to ensure deadlines and deliverables are met. Join customer meetings and presentations, presenting product in support of the sales team, capturing action items, and ensuring timely follow-through (travel required). Support the sales team with materials, presentations, and follow-up for key customer meetings. Assist with order tracking, reporting, and general sales support as needed. Skills & Abilities Strong organizational skills and attention to detail. Excellent communication and interpersonal skills; comfortable engaging with customers and internal teams. Ability to manage multiple priorities with a proactive, solution-oriented mindset. Proficiency in Microsoft Office (Excel, PowerPoint, Outlook) and ability to learn new systems quickly. Commitment to developing a long-term career with Don Lee Farms in sales and commercialization. Qualifications Bachelor's degree preferred, or equivalent experience. 1+ year of professional experience (internships and part-time work welcome). The expected base salary for this position is between $65,000 and $125,000 annually, depending on relevant experience and qualifications. Equal Opportunity Statement Don Lee Farms is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by law. Employment is contingent upon completion of a background check and verification of eligibility to work in the United States.

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

Clinical Research Associate I - (10028264) Description Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. Join us as a Clinical Research Associate, where you'll manage multiple research protocols to ensure efficiency and regulatory compliance while attending clinics as needed. You'll handle data compilation, registration, and submission, and maintain an effective system for data flow. Benefit from mentorship by experienced staff in a dynamic research environment. As a successful candidate, you will: · Manages and maintains protocol documentation and regulatory documents for IRB, DSMB, and PRMC/CPRMC. · Compiles, submits, and processes data and specimens per protocol requirements, ensuring accuracy and safety. · Establishes and maintains professional relationships with patients and hospital staff while ensuring confidentiality. · Assists in patient recruitment, protocol-related tests, and evaluations, and performs protocol-specific duties. · Conducts research activities under close supervision, including laboratory experiments in microbiology, molecular biology, genetics, biochemistry, and informatics. · Identifies and communicates protocol and data management issues to the supervisor, maintains professional development, and ensures an organized work environment. Qualifications Your qualifications should include: · Associate's Degree or equivalent experience; one year in a health care setting, preferably research, with medical terminology and writing skills. · Bachelor's Degree preferred. City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here. To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: United States-California-MonroviaJob: Laboratory ResearchWork Force Type: OnsiteShift: DaysJob Posting: Feb 10, 2025Minimum Hourly Rate ($): 32.000000Maximum Hourly Rate ($): 41.554100

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Assists with prescreening of potential research participants for various clinical trials. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Additional Qualifications/Responsibilities Qualifications Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: No experience required. One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats. Minimum Salary 21.29 Maximum Salary 33.00

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Job DescriptionTitle: Clinical Site Monitor Location: Los Angeles, CA Duration: 6 Months (Possibility of extension) Responsibilities • Perform/facilitate time-efficient pre-study initiation process. • Orient site personnel to study protocol/procedures. • Monitor compliance to FDA Regulations and Client SOP. • Manage study site activities through frequent on-site visits and telephone contracts • Position located in Los Angeles, CA area and will manage sites in this area and help region cover Northern and Southern California as needed. Requirements: • Direct multi-therapeutic site monitoring experience, including oncology experience • On-site monitoring experience required of multiple protocols in multiple therapeutic areas, including oncology. • Please ensure the Therapeutic Areas and the # of studies handled by the candidate is also listed on the resume. Qualifications• Direct multi-therapeutic site monitoring experience, including oncology experience • On-site monitoring experience required of multiple protocols in multiple therapeutic areas, including oncology. • Please ensure the Therapeutic Areas and the # of studies handled by the candidate is also listed on the resume. Additional Information This Job is with one of my pharmaceutical client.

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

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

Company DescriptionJobs for Humanity is partnering with CEDARS-SINAI to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located. Company Name: CEDARS-SINAI Job Description Grow your career at Cedars-Sinai! The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer! Join our team and contribute to groundbreaking research! Job Summary: This position functions as a Sr. Clinical Research Finance Coordinator, responsible for coordinating and executing the financial billing of clinical trials, formation of the Medicare Coverage Analysis grid, and the development of clinical trial budgets. He/She is responsible for the calculation of statistical, fiscal, and metric data as it relates to clinical trial activities. The Sr. CRFC also assures the building of budgets/contract agreements within the Clinical Trial Management System (CTMS). This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully oversee the research billing aspects of the Medical Care Foundation. Primary Duties and Responsibilities • Develops and updates Medicare Coverage Analysis grids in order to assess which procedures/services within the protocol are covered under Medicare guidelines. Works in conjunction with Cedars-Sinai Industry Sponsored Research Office in order to produce a final document. • Routinely monitors and reconciles trial accounts to ensure timely deposit, correct allocation, and distribution of revenue. • Provides financial related data as needed, to internal team members and/or manager/director. • Work with Accounts Payable to process and monitor that timely payments are made to various internal groups, external partners, patients, and/or joint sites according to contractual/budgetary agreement. • Responsible for accurate and timely fiscal data collection, documentation, entry and reporting into CTMS, including timely response to sponsor communication. • Develop and maintain statistical and fiscal reports as they relate to clinical trial activity on a monthly and fiscal year basis. • Process timely invoices which follow protocol driven procedures according to patient accruals/visits in order to seek reimbursement from industry sponsors. • Oversees and monitors billing work queue within the Electronic Medical Records system (EPIC) and adjudicates patient bills according to final contract/budget. • Critically evaluates research protocols to assess resource needs; assessment includes all research procedures, clinical research staff time, investigator time, and costs from ancillary departments. • Develops clinical trial budgets and negotiates with industry sponsors. Renegotiates budgets as part of trial maintenance through amendments. • Creates and finalizes payment terms (contract language) in conjunction with industry sponsor. • Ensures compliance with all federal and local agencies including the FDA and IRB Maintains strict patient confidentiality according to HIPAA regulations and applicable law. • Perform other duties as assigned Educational Requirements: High School Diploma/GED (Minimum) Bachelor's Degree (Preferred) 2 years Clinical research budgeting/billing required CCRP - Certification In Clinical Research preferred Physical Demands: Perform continuous operation of a personal computer for four hours or more. Use hands and fingers to handle and manipulate objects and/or operate equipment. Working Title: Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute Department: Angeles Research Business Entity: Cedars-Sinai Medical Care Foundation Job Category: Academic/Research Job Specialty: Contract & Grant Budgeting/Funding Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day Base Pay:$28.52 - $44.21

Job Description We are seeking a highly organized and motivated Senior Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field or equivalent experience. At least 1-2 years of experience in clinical research preferred. Phlebotomy certification or MA certification preferred. Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials, especially in a hospital or academic setting. Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus. Job Type: Full-time Work Location: In person Schedule: 8 hour shift Monday to Friday Weekends as needed

***Please note: This position is onsite and not remote. Candidates must be based in the Orange, CA area, as relocation assistance is not provided. Only individuals authorized to work in the U.S. will be considered.*** Job description Job Title: Senior Clinical Research Coordinator (Liver Trials) Job Type: Full\-Time | On\-Site Job Location: Orange, CA Job Salary: $90,000\-$100,000 per year (based on experience) Industry: Clinical Research | Hepatology | Phase I-IV Trials About Us: We're a fast\-paced, compliance\-driven research clinic specializing in liver disease trials-from NASH and cirrhosis to hepatocellular carcinoma. Our team partners with leading sponsors and CROs to deliver high\-quality, audit\-ready data and compassionate patient care. Position Overview: This is an on\-site position in Orange, CA, and applicants must reside within a commutable distance of 50 miles or less or be able to independently relocate. THIS IS NOT A REMOTE POSITION. We're seeking a Senior Clinical Research Coordinator (CRC) with hands\-on experience in liver\-focused clinical trials. You'll lead study execution, regulatory coordination, and patient engagement across multiple protocols. MUST HAVE \- Experience in CRC in Liver\/GI\/Obesity studies MUST HAVE \- Regulatory experience MUST HAVE \- Fluency in Spanish Key Responsibilities • Coordinate Phase I-IV liver trials, including screening, enrollment, and follow\-up • Manage regulatory submissions (IRB, CPHS), source documentation, and AE reporting • Oversee biospecimen handling and lab coordination • Maintain CTMS and EDC systems (REDCap, Medidata, etc.) • Mentor junior CRCs and support cross\-functional study teams Requirements Qualifications • 3-5+ years of CRC experience in liver\/hepatology trials • Strong knowledge of FDA, ICH\-GCP, and HIPAA regulations • Proficiency in CTMS, EDC platforms, and protocol adherence • Excellent communication and documentation skills • Bilingual (Spanish\/English) preferred • Familiarity with California specific regulations Certifications • GCP Training (Required) • HIPAA & Human Subjects Protection (Required) • CPHS Compliance Training (Required) • CCRC (Certified Clinical Research Coordinator) (Preferred) • CCRP (Certified Clinical Research Professional) (Preferred) Benefits • Competitive salary + performance bonuses • Health, dental, and vision coverage • Paid training and certification support • Career growth in a high\-impact research setting "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"673084038","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Pharma\/Biotech\/Clinical Research"},{"field Label":"Work Experience","uitype":2,"value":"4\-5 years"},{"field Label":"Salary","uitype":1,"value":"$90,000\-$100,000 per year"},{"field Label":"City","uitype":1,"value":"Orange"},{"field Label":"State\/Province","uitype":1,"value":"California"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"92868"}],"header Name":"Senior Clinical Research Coordinator (CRC)","widget Id":"**********00072311","is JobBoard":"false","user Id":"**********00216003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":true,"job Id":"**********04298063","FontSize":"12","google IndexUrl":"https:\/\/smarterhrsolutions.zohorecruit.com\/recruit\/ViewJob.na?digest=kSkbnHeM0@ULfN8kre4OLNZp8mJ@hHaCOOVpCYGzQWg\-&embedsource=Google","location":"Orange","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"2oxsac7e1f4138a8a48e1b2b76fabf6b3a45c"}

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. 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 The Role We are seeking an experienced Clinical Research Coordinator/Clinical Research Coordinator III for our Artemis Institute of Research clinical trial site located in Riverside, California. Under the supervision of the Site Director, the Senior Clinical Research Coordinator is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Senior Clinical Research Coordinator manages study conduct from planning through study closeout. Position Type: Full Time Pay Range: $76,000-$90,000/yr Location: Riverside, CA Work Schedule: Monday through Friday, 9:30am-6:00pm Responsibilities: In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending investigator meetings Experience managing multiple studies as the primary coordinator and someone ready to take the next step in managing people Providing the highest level of care for study patients and delivering excellent customer service to the pharmaceutical clients Qualifications: Nursing license, medical assistant certificate or registration preferred Minimum of two years of experience as a designated Clinical Research Coordinator on clinical trials required; sponsor-initiated and pharma clinical trials preferred Previous clinical experience in a hands-on patient-facing role required Commitment and ability to deliver excellent customer service Excellent communication, punctual and responsible Extremely well organized Excellent verbal and written communication skills Trustworthy, reliable; attentive to details Mature and pleasant demeanor Willingness to learn new tasks and grow with the company California Pay Range$76,000-$90,000 USD

Job Description Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. Position Summary We are seeking a dedicated and experienced Senior Clinical Research Coordinator (CRC) to join our team. The ideal candidate will play a key role in managing clinical trials across multiple sites, ensuring compliance with regulatory requirements and study protocols while maintaining the highest standards of participant safety and data integrity. The position requires regular travel to study sites, making it essential for the candidate to be adaptable and organized. This role is non-exempt (hourly) and full-time, working 40 hours per week, Monday through Friday in our Torrance office. Key Responsibilities Site Management: Oversee the day-to-day operations of clinical trials at various sites, ensuring adherence to study protocols, regulatory compliance, and good clinical practice (GCP). Training & Mentorship: Provide training and support to junior CRCs and site staff, fostering a collaborative environment and ensuring proficiency in study procedures. Participant Interaction: Engage with study participants, including recruitment, informed consent, and addressing any questions or concerns regarding the study process. Data Collection & Documentation: Ensure accurate and timely collection, documentation, and reporting of study data in accordance with regulatory guidelines and sponsor requirements. Regulatory Oversight: Maintain all necessary regulatory documentation, including IRB submissions, regulatory binders, and serious adverse event (SAE) reporting. Sponsor & Stakeholder Communication: Act as the primary point of contact between the sponsor, study sites, and internal teams, facilitating effective communication and resolution of any issues that arise. Quality Assurance & Compliance: Participate in site visits and audits, ensuring compliance with all study protocols and regulations. Additional duties as assigned. Minimal travel required between sites across Southern California (LA & SD) and Arizona Qualifications & Requirements Education: Bachelor's degree in a related field (e.g., life sciences, nursing, or similar). Experience: Minimum of 5 years of experience in clinical research, with at least 2 years as a Clinical Research Coordinator. Experience in a variety of therapeutic areas is a plus. Licensure & Certifications: Preferred Certification in clinical research (e.g., ACRP or SOCRA certification). Skills & Abilities: Strong knowledge of GCP, FDA regulations, and clinical trial processes. Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously. Strong communication and interpersonal skills, capable of working collaboratively with diverse teams. Proven ability to work independently and handle challenging situations effectively. Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) tools. Compensation The hourly range for this position is $36.00-40.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience. Physical Requirements Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable. What We Offer Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network) An opportunity to play an active role in medical advancement If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success! California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

JOB TITLE: Independent Studies Coordinator REPORTS TO: School Director CLASSIFICATION: Exempt / Full-Time The Independent Studies Coordinator is responsible for designing, managing, and implementing the independent study program at Academy of Creative Technologies - Antelope Valley. This role ensures academic integrity, compliance with California Ed Code, and personalized learning for students enrolled in independent study. The Coordinator will work in collaboration with instructional staff, support teams, and families to develop and monitor individualized learning plans that align with student goals, state standards, and school expectations. Key Responsibilities Coordinate all aspects of the independent study program, including intake, orientation, curriculum planning, and weekly check-ins with students and families. Create and maintain individualized learning contracts and master agreements in compliance with California Education Code requirements. Monitor student progress, attendance, work product submissions, and engagement to ensure satisfactory academic achievement. Work directly with students to provide guidance, instruction, and academic support in completing assigned independent study coursework. Collaborate with facilitators, education specialists, and the Care Team to support differentiation, interventions, and accommodations for students in independent study. Ensure timely submission of student work samples and documentation for state reporting, audits, and internal recordkeeping. Use educational technology platforms to track assignments, communication, and student performance (e.g., Google Workspace, School Pathways, Edmentum). Analyze student performance data to recommend interventions or transitions between independent study and general education settings as appropriate. Meet regularly with the School Director and instructional leadership to align independent study with broader school goals and instructional initiatives. Coordinate and oversee independent study meetings, including monthly reviews, student progress conferences, and mid-year reassessments. Maintain accurate and up-to-date records, including academic transcripts, credits earned, graduation progress, and assessment participation. Provide training and support to staff and families regarding independent study policies, procedures, and expectations. Serve as a liaison with external partners, home educators, and postsecondary institutions when applicable. Qualifications Bachelor's Degree in Education, Curriculum & Instruction, or related field required; teaching credential or administrative credential preferred. Minimum 3 years of experience in a K-12 educational setting, with prior experience in independent study, personalized learning, or online instruction strongly preferred. Strong working knowledge of California independent study laws, instructional design, and alternative education models. Familiarity with Individualized Education Programs (IEPs), 504 Plans, and Response to Intervention (RTI) processes. Proficient in student data systems, academic monitoring platforms, and digital learning tools. Demonstrated ability to work with diverse student populations and develop inclusive learning plans. Excellent organizational, interpersonal, and communication skills. Ability to work independently and collaboratively in a fast-paced, evolving school environment. Commitment to the mission, vision, and educational philosophy of Academy of Creative Technologies - Antelope Valley. Compensation Compensation is commensurate with experience and placement on the appropriate pay rate chart. Application Requirements Please include a cover letter, resume, and any relevant credentials or documentation of prior work in independent study, alternative education, or student case management. Academy of Creative Technologies - Antelope Valley is an equal opportunity employer committed to fostering a diverse and inclusive educational community. We encourage candidates from all backgrounds to apply.

Job Description 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 into 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 Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact Study Preparation: Ability to understand and follow institutional SOPs Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff Assist with planning and creation of appropriate recruitment and marketing materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives Assist in the creation or review of protocol specific source documents Determine facility, equipment and outsource vendor requirements and availability Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks Study Management: Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion 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 Strong and clear communication skills, both verbally and in writing Accept accountability for actions and function independently Patient Coordination: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial Administer delegated study questionnaires, where appropriate. Collect and evaluate medical records with the support of medically qualified members of the study team. Complete visit procedures and ensure proper specimen collection, processing and shipment 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 Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. Monitor patient progress on study medication Documentation: Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart Accurately transcribe data to CRF or EDC. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor. Complete Note(s)-to-File for patient chart and regulatory filing if necessary Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Perform other duties as assigned. The Expertise Required Excellent working knowledge of clinical trials, medicine and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ 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. Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. 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: BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred RN or LPN preferred Research Professional Certification- CRCC or exam eligibility preferred A minimum of 3 to 4 years Clinical Research experience A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide. Travel: Duties may require travel in the following models: Two weeks on / One week off deployments Temporary Event Support (3-7-day deployment durations) Weekly deployments (one week on, 2-5 days off). Frequency and length of travel may depend on the length and location of study, site, and event. Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Benefits & Perks (US Full Time Employees Only) 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: ********************************