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Clinical Research Associate jobs at AstraZeneca

- 328 jobs
  • Clinical Project Manager

    EPM Scientific 3.9company rating

    Trenton, NJ jobs

    Base Salary: $150K USD + Bonus | Full-Time | Remote Globally recognized, publicly traded full-service CRO that's redefining clinical research across continents. With a footprint in over 30 countries and a workforce of 10,000+, this organization partners with thousands of biopharma and medtech innovators to bring cutting-edge therapies to market. From oncology to rare diseases, their pipeline is as diverse as their team. Leveraging AI-powered platforms and real-world data, they're not just conducting trials-they're shaping the future of medicine. If you're a Clinical Project Manager looking to lead global studies in a collaborative, tech-forward environment, this is your chance to thrive. Key Responsibilities Lead and manage global Phase I-IV clinical trials across cardiovascular and oncology indications Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution. Develop and maintain project timelines, budgets, and risk mitigation strategies. Serve as the primary point of contact for sponsors, vendors, and internal stakeholders. Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency. Contribute to business operations including budgeting, forecasting, and resource planning. Mentor junior team members and foster a culture of excellence and innovation. Qualifications Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager. Must have direct experience managing both cardiovascular and oncology studies. Experience across multiple phases, preferably Phase II-III. Global trial management experience is essential. CRO experience strongly preferred. Strong understanding of drug development processes and clinical trial regulations. Valid and current GCP certification required. Solid knowledge of local regulatory requirements in the U.S. and/or EU. Proven experience in budgeting and business operations related to clinical project management. Excellent communication, leadership, and problem-solving skills. If you or someone you know fits this experience and shows interest, we'd love to speak with you!
    $150k yearly 4d ago
  • Experienced Clinical Research Associate, CRA (Home-Based, anywhere in Denmark)

    Medpace 4.5company rating

    Denmark, SC jobs

    Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 50+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $53k-85k yearly est. Auto-Apply 11d ago
  • Research Associate Clinical/Data Entry (Per Diem)

    Parexel International 4.5company rating

    Baltimore, MD jobs

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $20-22 hourly Auto-Apply 31d ago
  • Research Associate Clinical/Data Entry (Per Diem)

    Parexel 4.5company rating

    Baltimore, MD jobs

    **Job Title:** Entry level Research Associate (per diem) **Clinical/Data Entry** **Work Location:** onsite in Baltimore, MD (some of the data entry work can be done remotely after training) **Parexel Early Phase Clinical Unit** supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans. **At Parexel Baltimore, MD unit our** highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. **What you'll do after training is completed** (including but not limited): **_Clinical:_** + You will understand study protocols and be able to complete required medical procedures. + Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. + Enter study participants in the study participant tracking system + Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results + Prepare/monitor study supplies and stock levels in clinic/hospital. + Ensure basic study participant safety is provided. + Assist with Monitor visits (i.e., room set up, etc.). + Maintain and update knowledge of Clinical Operating Guidelines and their proper application. + Assume appropriate role with study participants and caregivers. + Assure quality and accuracy of source and CRF documentation. **_Data Entry:_** + Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. + Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. + Review Case Report Forms to confirm capture of data according to protocol and amendments. + Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. + Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. + Organize track and report status of data entry to ensure that study data timelines are met. + Check, review and ensure timely submission of data clarifications/queries. **Your Profile:** + Proven customer service experience in a fast-paced environment + Background working in a medical or clinical setting + Comfortable with prolonged periods of standing and walking + B.S.+ in related life science field OR HS diploma/GED with relevant experience + CPT/Phlebotomy is highly preferred **Hours/Shift** - _please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits)_ **Required Training:** First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) + **Minimum availability requirements:** 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month + The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) + **Shift Details:** Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) + Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete **Base Pay Range:** $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $20-22 hourly 29d ago
  • Clinical Research Scientist - Breast Cancer Franchise

    Eli Lilly and Company 4.6company rating

    Stamford, CT jobs

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $83k-111k yearly est. Auto-Apply 26d ago
  • Trial Master File (TMF) Specialist Oncology

    Sunovion 4.9company rating

    Marlborough, MA jobs

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. Key Responsibilities * Responsible for overall quality, maintenance, and completeness of Trial Master Files. * Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. * Develop project specific TMF plan and structure and update the plan as needed. * Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. * Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. * Act as a liaison between the Site IRBs and study team to resolve queries and concerns. * Provide study team reports or updates regarding status of TMF on a regular basis. * Participate in audits and provide documents as requested. * Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. * Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. * Champion best practices for building and maintaining TMF health. Professional Experience / Qualifications * BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings * Knowledge of and direct experience with Trial Master Files. * Prior eTMF (e.g. Veeva) administration required. * Strong Microsoft Office skills required. * Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). * Fundamental knowledge of the conduct of clinical trials is preferred. * Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
    $72.5k-90.6k yearly Auto-Apply 40d ago
  • Clinical Research Scientist

    Mitsubishi Tanabe Pharma America 4.1company rating

    Jersey City, NJ jobs

    Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
    $75k-125k yearly est. 13h ago
  • Consumer Study Coordinator (30 hrs/wk) - Richmond, Virginia

    Celerion 4.2company rating

    Richmond, VA jobs

    Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is currently seeking a Consumer Study Coordinator at our Richmond, VA location. Our Richmond location focuses on consumer opinion studies related to nicotine and tobacco products. This position will work 30 hours per week and is eligible for benefits. We are looking for someone who has the flexibility to work between the hours of 8:00am-8:00pm Monday-Friday, with the possibility of the occasional Saturday. As a Consumer Study Coordinator, you will be responsible for the preparation and maintenance of all stages of participant activities, including screening, training, and evaluations. Primarily, this is a customer service-based role, developing positive participant communications and relationships. Other duties include entering and updating study information into computer systems, and collecting and organizing panelists' paperwork and documentation. Requirements:We are seeking candidates with at least two years of customer service experience, administrative skills and the ability to work a flexible schedule. Consumer/market research experience is preferred. Ability to work in the required work environment, including but not limited to exposure to secondhand smoke from combustible cigarettes and vapors from electronic cigarettes on a daily basis. According to the Code of Virginia 18.2-371.2B, employees must be 21 years of age to work around tobacco products.Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
    $34k-46k yearly est. Auto-Apply 35d ago
  • Consumer Study Coordinator (30 hrs/wk) - Richmond, Virginia

    Celerion 4.2company rating

    Richmond, VA jobs

    Job DescriptionCelerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is currently seeking a Consumer Study Coordinator at our Richmond, VA location. Our Richmond location focuses on consumer opinion studies related to nicotine and tobacco products. This position will work 30 hours per week and is eligible for benefits. We are looking for someone who has the flexibility to work between the hours of 8:00am-8:00pm Monday-Friday, with the possibility of the occasional Saturday. As a Consumer Study Coordinator, you will be responsible for the preparation and maintenance of all stages of participant activities, including screening, training, and evaluations. Primarily, this is a customer service-based role, developing positive participant communications and relationships. Other duties include entering and updating study information into computer systems, and collecting and organizing panelists' paperwork and documentation. Requirements:We are seeking candidates with at least two years of customer service experience, administrative skills and the ability to work a flexible schedule. Consumer/market research experience is preferred. Ability to work in the required work environment, including but not limited to exposure to secondhand smoke from combustible cigarettes and vapors from electronic cigarettes on a daily basis. According to the Code of Virginia 18.2-371.2B, employees must be 21 years of age to work around tobacco products.Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $34k-46k yearly est. 5d ago
  • Consumer Study Coordinator (30 hrs/wk) - Richmond, Virginia

    Celerion 4.2company rating

    Richmond, VA jobs

    Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is currently seeking a Consumer Study Coordinator at our Richmond, VA location. Our Richmond location focuses on consumer opinion studies related to nicotine and tobacco products. This position will work 30 hours per week and is eligible for benefits. We are looking for someone who has the flexibility to work between the hours of 8:00am-8:00pm Monday-Friday, with the possibility of the occasional Saturday. As a Consumer Study Coordinator, you will be responsible for the preparation and maintenance of all stages of participant activities, including screening, training, and evaluations. Primarily, this is a customer service-based role, developing positive participant communications and relationships. Other duties include entering and updating study information into computer systems, and collecting and organizing panelists' paperwork and documentation. Requirements: We are seeking candidates with at least two years of customer service experience, administrative skills and the ability to work a flexible schedule. Consumer/market research experience is preferred. Ability to work in the required work environment, including but not limited to exposure to secondhand smoke from combustible cigarettes and vapors from electronic cigarettes on a daily basis. According to the Code of Virginia 18.2-371.2B, employees must be 21 years of age to work around tobacco products. $19 - $19 an hour Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $19-19 hourly 9d ago
  • Clinical Research Coordinator

    Wake Research 3.7company rating

    Newport Beach, CA jobs

    M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Newport Beach, CA. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience and current certification/license to perform phlebotomy in the state of California is preferred Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *This position offers a competitive salary of $25/hr - $35/hr. *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1
    $25-35 hourly 60d+ ago
  • Clinical Research Assistant - David Turbay MD PLLC

    Elligo Health Research Inc. 3.7company rating

    El Paso, TX jobs

    Job DescriptionDescription: The Clinical Research Assistant plays a key role in assisting with the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary function of the Clinical Research Assistant is to support the Clinical Research Coordinators (CRCs) and the broader study team in the successful execution of clinical trials to achieve study objectives and corporate goals. This role is responsible for a variety of tasks, including administrative duties, data management/entry, patient interaction and technical procedures such as phlebotomy, performing ECGs and vital signs. Additional focus is on specimen collection, specimen handling and transport, specimen processing, lab manual creation, reviewing lab results and inventory monitoring. ESSENTIAL DUTIES: Maintain a safe, clean working environment, including infection control requirements Perform specimen collections, includes venipuncture to pediatric and adult participants Process specimens received in the laboratory. This task includes specimen transport, handling, sorting, requisition entry, inventory accountability, and reviewing lab results for PI review. Performing CLIA waived testing such as urine pregnancy testing, urine dip analysis, urine drug screen testing, alcohol testing, Rapid Antigen Testing Ensure specimen collection/processing/shipping are performed according to protocol Complete study training and available for additional duties to support study conduct as needed, which may include: Assist with the screening, recruiting and enrollment of research subjects. Assist in the informed consent process of research subjects Collect patient/research participant history Data entry and Management per Good Documentation Practice Coordinate follow-up care and laboratory procedures Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.) Performing vitals, ECG, spirometry Coordinate protocol related research procedures, study visits, and follow- up care Develop strong working relationships and maintain effective communication with study team members Develop strong working relationships with the investigators and staff to build a foundation of trust and respect Adhere to an IRB approved protocol Support the safety of research subjects Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines Perform other duties as required and/or assigned. QUALIFICATIONS: Experience with Athena EMR preferred Clear and concise written and oral communication skills to interact effectively with coworkers and study staff (including sponsor/CRO). Strong organizational skills including the ability to accomplish multiple tasks within established timeframes through effective prioritization of duties and functions in a fast-paced environment. Ability to recognize and synthesize information Ability to act and operate independently with minimal daily direction from manager to accomplish objectives Strong attention to detail and accuracy Excellent interpersonal and customer relationship skills Aptitude to work effectively and positively with a team and diverse group of individuals Basic skill level with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint) Basic knowledge of medical terminology preferred EDUCATION AND EXPERIENCE: Bilingual (English/Spanish) required Minimum 1 year of experience in clinical research or a patient facing, clinical setting Associates degree a plus Certification in phlebotomy, ECGs or similar clinical skills preferred Requirements: Bilingual (English/Spanish) required Minimum 1 year of experience in clinical research or a patient facing, clinical setting Associates degree a plus Certification in phlebotomy, ECGs or similar clinical skills preferred
    $36k-49k yearly est. 23d ago
  • Clinical Research Coordinator

    Wake Research 3.7company rating

    Raleigh, NC jobs

    M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience is highly preferred Previous experience as a medical assistant, LPN, or RN Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1
    $44k-65k yearly est. 60d+ ago
  • Clinical Research Coordinator - PRN/ Contractor

    Wake Research 3.7company rating

    Sandy Springs, GA jobs

    M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1
    $45k-66k yearly est. 5d ago
  • Clinical Research Assistant

    Retina Consultants of Houston 4.0company rating

    The Woodlands, TX jobs

    Retina Consultants of Texas (RCTX) is seeking a Research Assistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Woodlands Clinic. Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules. Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients. We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience. In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period: Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire. Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually. Starting Pay Rate is $19.00 per hour and eligible for overtime. RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Inform subjects and obtain written consent in regard to ICF's Assist Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol Scribe ocular exams for doctors and confirm appropriate treatment per protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Collection, processing, and shipment of laboratory biological samples for analysis Perform intraocular pressure checks post-injections Review and resolve data management queries as needed Trial frame refraction and ETDRS visual acuity testing Other duties as assigned Qualifications Skills/Competencies: Biliginual preferred Ability to multitask Computer efficient Commnucates well both verbally and electronically; email, MS Teams, etc. Detail oriented Education Requirements Bachelors degree or 4 years of ophthalmic experience in lieu of degree Experience Requirements: No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
    $19 hourly Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Retina Consultants of Houston 4.0company rating

    The Woodlands, TX jobs

    Retina Consultants of Texas (RCTX) is seeking a Research Assistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Woodlands Clinic. Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules. Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients. We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience. In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period: Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire. Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually. Starting Pay Rate is $19.00 per hour and eligible for overtime. RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Inform subjects and obtain written consent in regard to ICF's Assist Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol Scribe ocular exams for doctors and confirm appropriate treatment per protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Collection, processing, and shipment of laboratory biological samples for analysis Perform intraocular pressure checks post-injections Review and resolve data management queries as needed Trial frame refraction and ETDRS visual acuity testing Other duties as assigned Qualifications Skills/Competencies: Biliginual preferred Ability to multitask Computer efficient Commnucates well both verbally and electronically; email, MS Teams, etc. Detail oriented Education Requirements Bachelors degree or 4 years of ophthalmic experience in lieu of degree Experience Requirements: No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
    $19 hourly Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Eurofins Scientific 4.4company rating

    Forest, VA jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description This role reports to the Clinical Manager and is part of a new team with the Eurofins network, supporting Phase I-III IND clinical trials with Hair, Skin and Nail evaluation endpoints. We will train the right candidate but experience in any discipline of Clinical research (especially from a regulatory aspect) is a plus. You will work closely with a small team inclusive of 2 Principal Investigators in Dermatology. Clinical Research Assistant responsibilities include, but are not limited to, the following: * Project support inclusive of project planning, Preparation of paperwork and documentation, and maintaining study participant records. * Data collection * Audits (both virtual and in person) * General preparation and closing of studies * Working with IRB submissions * Assisting with Study participant recruitment inclusive of phone and in person screening and subject scheduling * Executing Study participant visits inclusive of subject vitals (possibly Phlebotomy but will train) , electronic data entry, visual evaluations and PI assistance. * Clinical Trial data entry * Other tasks as dictated by business needs and the Clinical Manager Qualifications Basic Minimum Qualifications: * Certified CRA credential ideal * Minimum 1+ years expereince in clinical research * Experience in regulatory aspects of Phase I-III clinical IND trials and experience with FDA audits. * Experience with Microsoft platforms, EMR and EHR (electronic health record) systems and CTMS strongly preferred. * Experience with phlebotomy preferred. * Authorization to work in the United States indefinitely without restriction or sponsorship. Additional Information Position is full-time working Monday - Friday 9:00 am - 5:00pm. Candidates must be within a commutable distance to Forest, VA. * Excellent full-time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $33k-44k yearly est. 6d ago
  • Clinical Research Assistant

    Retina Consultants of Houston 4.0company rating

    Bellaire, TX jobs

    Retina Consultants of Texas (RCTX) is seeking a Research Assistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Bellaire Clinic. Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules. Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients. We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience. In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period: Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire. Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually. Starting Pay Rate is $19.00 per hour and eligible for overtime. RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Inform subjects and obtain written consent in regard to ICF's Assist Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol Scribe ocular exams for doctors and confirm appropriate treatment per protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Collection, processing, and shipment of laboratory biological samples for analysis Perform intraocular pressure checks post-injections Review and resolve data management queries as needed Trial frame refraction and ETDRS visual acuity testing Other duties as assigned Qualifications Skills/Competencies: Biliginual preferred Ability to multitask Computer efficient Commnucates well both verbally and electronically; email, MS Teams, etc. Detail oriented Education Requirements Bachelors degree or 4 years of ophthalmic experience in lieu of degree Experience Requirements: No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
    $19 hourly Auto-Apply 5d ago
  • Clinical Research Assistant

    Retina Consultants of Houston 4.0company rating

    Katy, TX jobs

    Retina Consultants of Texas (RCTX) is seeking a Research Assistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Katy Clinic. Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules. Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients. We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience. In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period: Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire. Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually. Starting Pay Rate is $19.00 per hour and eligible for overtime. RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Inform subjects and obtain written consent in regard to ICF's Assist Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol Scribe ocular exams for doctors and confirm appropriate treatment per protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Collection, processing, and shipment of laboratory biological samples for analysis Perform intraocular pressure checks post-injections Review and resolve data management queries as needed Trial frame refraction and ETDRS visual acuity testing Other duties as assigned Qualifications Skills/Competencies: Biliginual preferred Ability to multitask Computer efficient Commnucates well both verbally and electronically; email, MS Teams, etc. Detail oriented Education Requirements Bachelors degree or 4 years of ophthalmic experience in lieu of degree Experience Requirements: No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
    $19 hourly Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Retina Consultants of Houston 4.0company rating

    Katy, TX jobs

    Retina Consultants of Texas (RCTX) is seeking a Research Assistant to join our innovative team with the mission of Fighting Blindness For The World To See. This position will be responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. This position will be based at the Katy Clinic. Candidates must be able to meet the needs of the patients and providers, and support the Research Department hours of 6:30am-5pm Monday through Friday. Schedules are provided weekly and are based on the provider's clinic, patient and surgery schedules. Retina Consultants of Texas is the largest and most respected retina-only ophthalmology practice in the United States. Our group consists of 26 world renowned physicians leading the world in retinal care. While serving two major metropolitan markets (and their extensions) our combined culture allows us to best serve our patients, referral sources and our own team of physicians. RCTX also invests heavily in diagnostic equipment, providing state-of-the-art retina imaging, laser and diagnostic capabilities to each patient. This, combined with the clinical expertise of our physicians, an outstanding and devoted staff, and 25 convenient locations to serve our patients. We worked hard to create our culture as Retina Warriors. We strongly emphasize our core values of Hard Work, Authentic Care and Innovation in everything we do. It is our belief that by investing in our people, our people will be empowered of their own accord to provide the highest quality patient experience. In addition to being highly challenged professionally, in joining our practice, the following competitive benefits for full-time eligible employees after a 60-day introductory period: Employee Paid Benefits such as Medical, Dental, and Vision, short-term disability, voluntary life insurance, accident, critical illness, hospital indemnity, pet insurance, HSA pre-taxed contributions, 401 (k) retirement savings contributions both Roth and Traditional options starting date of hire. Employer Paid Benefits such as long-term disability, $25,000 basic life insurance policy, 3% 401(k) safe harbor contribution, HSA employer contributions, annual performance merit increases, certification opportunities, rewards & recognition platform, WellHub Starter Plan Gym Membership, paid time off and (8) paid holidays + (1) floating holiday annually. Starting Pay Rate is $19.00 per hour and eligible for overtime. RCTX is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, age, national origin, disability, military service, veteran status, genetic information, or any other protected class under applicable law. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Inform subjects and obtain written consent in regard to ICF's Assist Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms on subject who require ECG per study protocol Scribe ocular exams for doctors and confirm appropriate treatment per protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Collection, processing, and shipment of laboratory biological samples for analysis Perform intraocular pressure checks post-injections Review and resolve data management queries as needed Trial frame refraction and ETDRS visual acuity testing Other duties as assigned Qualifications Skills/Competencies: Biliginual preferred Ability to multitask Computer efficient Commnucates well both verbally and electronically; email, MS Teams, etc. Detail oriented Education Requirements Bachelors degree or 4 years of ophthalmic experience in lieu of degree Experience Requirements: No experience required with a Bachelors degree otherwise at least 4 years of ophthalmic experience
    $19 hourly Auto-Apply 60d+ ago

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