Clinical Research Associate jobs at AstraZeneca

- 148 jobs

Clinical Research Associate I
Johnson & Johnson 4.7
Cincinnati, OH jobs
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: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America Job Description: About Surgery 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 the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech 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 *******************/. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Clinical Research Associate I. OVERALL RESPONSIBILITIES: On behalf of Clinical Affairs, Robotics and Digital Solutions, within Johnson & Johnson MedTech Surgery, the Clinical Research Associate I (CRA I) serves as the primary contact point between the Sponsor and the Investigational Site. The CRA I responsibilities include supporting the clinical trial team in study operations activities. The CRA I may be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through site closure. Key Job Activities: Principal Clinical Study Site Management Tasks Support clinical trial operational activities such as device management and study budget tracking. May act as primary local company contact for assigned sites for specific trials. May participate in site feasibility and/or pre-trial site assessment visits. Attend/participate in investigator meetings as needed. Partners with the clinical trial team to execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. May ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Work in close collaboration with Clinical Research Manager for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. Develops monitoring skills to ensure site staff complete data entry and resolve queries within expected timelines, and accuracy, validity and completeness of data collected at trial sites. Develops monitoring skills to ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. If conducting monitoring visits, fully document trial-related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Collaborate with the Clinical Research Manager for documenting and communicating site/study progress and issues to trial central team. Attend regularly scheduled team meetings and trainings. Comply with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. May prepare trial sites for close out, conduct final close out visit. Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff. May contribute to process improvement and training. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. May collaborate with contractors/vendors, and company personnel as needed. Administrative Tasks: CRA I knows, understands, incorporates, and complies with all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. May be asked to provide additional support to Clinical Affairs, Robotics and Digital Solutions staff, as needed. Job Qualifications: Education A Bachelor's Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. Experience Bachelor's degree with at least 3 years of relevant experience; Master's or PhD/MD/PharmD with at least 1 year of relevant experience. Previous clinical research experience required. Previous medical device monitoring or equivalent experience required. Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products. Relevant industry certifications preferred (e.g., CCRA, RAC, CDE). Knowledge Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, PowerPoint and Outlook). Additional Requirements: Strong computer skills in appropriate software and related company clinical systems Proficient in speaking and writing the country language, English Presentation and influencing skills Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines). Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required. A valid Driver's License issued in one of the 50 United States and a good driving record is required. Additional Information: The expected base pay range for this position is $76,000 - $121,900/ annually . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: o Vacation -120 hours per calendar year o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year o Holiday pay, including Floating Holidays -13 days per calendar year o Work, Personal and Family Time - up to 40 hours per calendar year o Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child o Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member o Caregiver Leave - 10 days o Volunteer Leave - 4 days o Military Spouse Time-Off - 80 hours Additional information can be found through the link below. ********************************************* 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, external applicants please contact us via *******************/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management The anticipated base pay range for this position is : 76000-121,900 Additional Description for Pay Transparency:
$76k-121.9k yearly Auto-Apply 2d ago
Principal Clinical Research Scientist - Abiomed
Johnson & Johnson 4.7
Danvers, MA jobs
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: Danvers, Massachusetts, United States of America Job Description: Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Principal Clinical Research Scientist. Remote work options may be considered on a case-by-case basis and if approved by the Company 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 *******************/. We are looking for a strong leader to support the development and design of Abiomed's global clinical studies with the focus on sound clinical evidence generation to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products. Primary Duties and Responsibilities: * Execute on Abiomed's scientific objectives within Abiomed-sponsored clinical studies * Serve as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studies * Own protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators and communication with FDA * Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions related to protocol development and study execution * Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations * Own steering committee meetings and serve as scientific lead on investigator/research coordinator meetings * Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies * Responsible for scientific content for all trial-related documents * Own annual and final report content development, and coordination of content from various stakeholders * Develop, maintain, and review periodic study reports - review for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures * Develop and execute publication/presentation charters for clinical studies * Ensure data analysis integrity for clinical studies within scope of role * Drive strong publication/presentation cadence for Abiomed sponsored clinical studies * Execute on the regulatory pathway required for new investigational devices and for indication expansion globally * Conduct literature review and clinical data review to support regulatory submissions and CERs * Cross-collaboration with other Medical Office departments Job Qualifications: * Advanced degree in science or engineering; PhD or MD required * At least 5 years relevant post-graduate research experience * At least 3 years clinical science/research experience in cardiology/cardiovascular space or medical devices required * Medical device and/or industry clinical research experience strongly preferred * Experience with scientific contribution to large multicenter clinical trials required * Excellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leaders * Strong understanding of biostatistics * Strong publication history in peer-reviewed journals * Knowledge of healthcare ethics, compliance regulations * Strong work ethic, self-motivated, team player with strong interpersonal skills * Ability to travel up to 15% (domestic and international) to attend site visits, investigator meetings, and scientific conferences 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. Required Skills: Preferred Skills: Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : $174,250 - $235,750 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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)). This position is eligible to participate in the Company's long-term incentive program. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
$174.3k-235.8k yearly Auto-Apply 9d ago
Clinical Research Associate - Surgery CSTAR - Based in Long Island and Manhattan
NYU Langone Medical Center 3.9
New York, NY jobs
NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram. Position Summary: We have an exciting opportunity to join our team as a Research Associate. In this role, the successful candidate is responsible for conducting independent basic science experimentation based on research conducted in the assigned laboratory under the mentorship of a senior scientist. Individual is expected to seek to build a portfolio of research accomplishments in preparation for acquiring a higher degree in biomedical research or medicine. Additional Position Specific Responsibilities: This role involves clinical research data collection, interaction with human subjects, and the maintenance of clinical research date data - this role does not include bench science research Performs in-person and over-the-phone participant recruitment. Performs data collection over the phone, by email or in dialysis centers, in-patient, and out-patient settings (or other clinical settings). Performs in-person and over-the-phone follow-up of participants who are enrolled in clinical trials and cohort studies. Conducts chart abstractions to ascertain clinical data Administers behavioral, exercise and other interventions in clinical settings. Reports enrollment, follow-up, and retention rates for clinical trials and cohort studies. Prepares and maintains Standard Operating Procedures(SOPs) for clinical trials and cohort studies. Performs specimen processing and storage. Maintains study databases by entering, cleaning, and verifying data for accuracy and completeness. Coordinates communication between study sites, clinical staff, and research team members to ensure protocol adherence and timely data collection. Participates in study team meetings and contributes to protocol development, recruitment strategies, regulatory submissions, and process improvement discussions. Assists in the development and pilot testing of study instruments, surveys, and data collection tools. Prepares study materials such as recruitment flyers, participant packets, and consent forms. Schedules and documents study visits, maintaining detailed logs for tracking participant flow and study progress. Assists in the preparation of reports, abstracts, posters, and manuscripts for presentations and publications. Ensures compliance with Good Clinical Practice (GCP) and institutional policies related to participant safety, confidentiality, and data management. Monitors study supplies and coordinates with laboratory and clinical teams to ensure proper inventory and equipment maintenance. Assists with quality assurance activities, including source document verification and internal audits. Supports grant and budget tracking, including study reimbursements and invoicing for multicenter projects. After a period of time working with the research team, the candidate will be expected to train newly hired Research Associates, graduate students, and postdoctoral fellows in the study design, data collection, blood processing technique, and other aspects of the research. Job Responsibilities: * After a period of time working in the laboratory, the candidate will be expected to train graduate students and post-doctoral fellows in experimental design, technique and performance. * Generates hypotheses and designs and performs experiments to test them. * Executes multiple experiments simultaneously over time independently. * Records all experimental findings in a laboratory notebook, analyze and interpret experimental findings. * Based on results, independently suggests and tests modifications to protocols. * Prepares figures and diagrams for presentations and publications. * Communicates results and collaborates with other professionals in the lab. * Demonstrates a significant level of intellectual input into the design of the project. * Presents findings at lab meeting, responds to challenges, and participates in exchanges of ideas to advance the science. * Reads and understands relevant scientific literature. * Contributes to the preparation of articles on research outcomes and progress and to the submission of same for publication. * Participates in the editing and proofing of grant proposals, annual grant reports, and manuscripts for publication and recommends modifications to the Principal Investigator. Additional Position Specific Responsibilities: This role involves clinical research data collection, interaction with human subjects, and the maintenance of clinical research date data - this role does not include bench science research Performs in-person and over-the-phone participant recruitment. Performs data collection over the phone, by email or in dialysis centers, in-patient, and out-patient settings (or other clinical settings). Performs in-person and over-the-phone follow-up of participants who are enrolled in clinical trials and cohort studies. Conducts chart abstractions to ascertain clinical data Administers behavioral, exercise and other interventions in clinical settings. Reports enrollment, follow-up, and retention rates for clinical trials and cohort studies. Prepares and maintains Standard Operating Procedures(SOPs) for clinical trials and cohort studies. Performs specimen processing and storage. Maintains study databases by entering, cleaning, and verifying data for accuracy and completeness. Coordinates communication between study sites, clinical staff, and research team members to ensure protocol adherence and timely data collection. Participates in study team meetings and contributes to protocol development, recruitment strategies, regulatory submissions, and process improvement discussions. Assists in the development and pilot testing of study instruments, surveys, and data collection tools. Prepares study materials such as recruitment flyers, participant packets, and consent forms. Schedules and documents study visits, maintaining detailed logs for tracking participant flow and study progress. Assists in the preparation of reports, abstracts, posters, and manuscripts for presentations and publications. Ensures compliance with Good Clinical Practice (GCP) and institutional policies related to participant safety, confidentiality, and data management. Monitors study supplies and coordinates with laboratory and clinical teams to ensure proper inventory and equipment maintenance. Assists with quality assurance activities, including source document verification and internal audits. Supports grant and budget tracking, including study reimbursements and invoicing for multicenter projects. After a period of time working with the research team, the candidate will be expected to train newly hired Research Associates, graduate students, and postdoctoral fellows in the study design, data collection, blood processing technique, and other aspects of the research. Minimum Qualifications: To qualify you must have a College graduate with a B.S. or B.A. in Biomedical or Physical Sciences. A minimum commitment of two years is required and placement in position may not exceed three years. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online. View Know Your Rights: Workplace discrimination is illegal. NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $47,033.89 - $63,600.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. To view the Pay Transparency Notice, please click here
$47k-63.6k yearly 5d ago
Clinical Research Associate 3
Grifols Sa 4.2
Raleigh, NC jobs
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Primary responsibilities include: * Tracking study specific tasks and progress of the trial. * Performing regulatory document review and approval for IP release. * Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). * Conducting monitor training. * Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. * Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. * Collaborating with data management to resolve queries. * Facilitating investigator site payments, as applicable. * Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. * Assisting in evaluation of vendor performance during conduct of the study. * Acquiring a basic knowledge of the therapeutic area and product. * Obtaining a complete understanding of all trial-related documents and operational procedures. * Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. * Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable * Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). * Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. * Preparing accurate and complete meeting minutes for various meetings. * Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. * Assists with effective and timely audit/inspection responses. For studies monitored in house by Grifols, additional responsibilities may include: * Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. * Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. * Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. * Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. * Reconciles clinical supplies and drug accountability records at study sites. * Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. * Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. * Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Additional responsibilities: Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. Knowledge, Skills, and Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. Requirements: * Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. * Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]
$55k-90k yearly est. 38d ago
Principal Clinical Research Scientist - Abiomed
J&J Family of Companies 4.7
Danvers, MA jobs
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:** Danvers, Massachusetts, United States of America **Job Description:** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Principal Clinical Research Scientist. _Remote work options may be considered on a case-by-case basis and if approved by the Company_ 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 *******************/. We are looking for a strong leader to support the development and design of Abiomed's global clinical studies with the focus on sound clinical evidence generation to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products. **Primary Duties and Responsibilities:** + Execute on Abiomed's scientific objectives within Abiomed-sponsored clinical studies + Serve as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studies + Own protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators and communication with FDA + Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions related to protocol development and study execution + Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations + Own steering committee meetings and serve as scientific lead on investigator/research coordinator meetings + Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies + Responsible for scientific content for all trial-related documents + Own annual and final report content development, and coordination of content from various stakeholders + Develop, maintain, and review periodic study reports - review for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures + Develop and execute publication/presentation charters for clinical studies + Ensure data analysis integrity for clinical studies within scope of role + Drive strong publication/presentation cadence for Abiomed sponsored clinical studies + Execute on the regulatory pathway required for new investigational devices and for indication expansion globally + Conduct literature review and clinical data review to support regulatory submissions and CERs + Cross-collaboration with other Medical Office departments **Job Qualifications:** + Advanced degree in science or engineering; PhD or MD required + At least 5 years relevant post-graduate research experience + At least 3 years clinical science/research experience in cardiology/cardiovascular space or medical devices required + Medical device and/or industry clinical research experience strongly preferred + Experience with scientific contribution to large multicenter clinical trials required + Excellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leaders + Strong understanding of biostatistics + Strong publication history in peer-reviewed journals + Knowledge of healthcare ethics, compliance regulations + Strong work ethic, self-motivated, team player with strong interpersonal skills + Ability to travel up to 15% (domestic and international) to attend site visits, investigator meetings, and scientific conferences 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. **Required Skills:** **Preferred Skills:** Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility **The anticipated base pay range for this position is :** $174,250 - $235,750 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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)). This position is eligible to participate in the Company's long-term incentive program. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
$174.3k-235.8k yearly 8d ago
Clinical Research Associate 3
Grifols Shared Services North America, Inc. 4.2
Rex, NC jobs
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. **Primary responsibilities include:** + Tracking study specific tasks and progress of the trial. + Performing regulatory document review and approval for IP release. + Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). + Conducting monitor training. + Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. + Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. + Collaborating with data management to resolve queries. + Facilitating investigator site payments, as applicable. + Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. + Assisting in evaluation of vendor performance during conduct of the study. + Acquiring a basic knowledge of the therapeutic area and product. + Obtaining a complete understanding of all trial-related documents and operational procedures. + Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. + Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable + Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). + Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. + Preparing accurate and complete meeting minutes for various meetings. + Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. + Assists with effective and timely audit/inspection responses. **For studies monitored in house by Grifols, additional responsibilities may include:** + Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. + Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. + Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. + Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. + Reconciles clinical supplies and drug accountability records at study sites. + Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. + Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. + Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. **Additional responsibilities:** Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. **Knowledge, Skills, and Abilities:** Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. **Requirements:** + Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. + Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands:** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 536724 **Type:** Regular Full-Time **Job Category:** R & D
$55k-89k yearly est. 37d ago
Research Associate Clinical/Data Entry (Per Diem)
Parexel International 4.5
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 4.5
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
Trial Master File (TMF) Specialist Oncology
Sunovion 4.9
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 Coordinator
Spine Network LLC 3.6
Shreveport, LA jobs
Description: Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future. The Clinical Research Coordinator (CRC) is primarily responsible for clinical research activities ensuring compliance with Code of Federal Regulation (CFR) Title 21, The Spine Network (TSN) Quality Program, and Good Clinical Practice (GCPs). The CRC is responsible for the day-to-day management of clinical trials, ensuring research studies run smoothly by consenting eligible participants, collecting accurate data, monitoring participant safety, and upholding compliance with regulatory guidelines, all while working closely with Sponsor and study sites to adhere to the study protocol and ethical standards throughout the research process. Supervisory Responsibilities: None. Duties/Responsibilities: Study Compliance and Coordination Ensure all study procedures adhere to protocols, organizational policies, and regulatory guidelines Stay updated on and apply GCP standards and Institutional Review Board (IRB) requirements Participant Management Identify and screen potential study participants through medical record reviews and interviews Obtain and document informed consent, clearly explaining study procedures and potential risks Coordinate and conduct study visits, including collecting and processing samples, administering questionnaires Record accurate data from study visits, including patient demographics, medical history, and study-specific measurements Regulatory and Documentation Prepare and manage study-related documents, including protocol worksheets, IRB submissions, adverse event reports, and progress updates Maintain and review the Trial Management File (TMF) and other regulatory documentation as necessary Data and Quality Oversight Monitor and record study data accurately, ensuring compliance with study protocols and reporting guidelines Prepare for and participate in quality assurance audits conducted by sponsors, federal agencies, or internal review groups Collaboration and Communication Coordinate with investigators, healthcare professionals, and study team members to ensure seamless study execution Build and maintain relationships with investigators, site staff, vendors, and contractors Review and address protocol issues, proposing resolutions or updates when required Additional Responsibilities Participate in continuing education and to maintain professional competency Perform other duties as assigned to support study success Requirements: Required Skills/Abilities: Familiarity with Electronic Medical Record (EMR) and radiology systems (PACS) Strong organizational and time management skills ACRP-CP or CCRC certified or willingness to obtain certification Attention to detail and accuracy in data collection and documentation Proficient in Microsoft Office applications (e.g., WORD, Excel, PowerPoint, Outlook, etc.) and electronic data capture (EDC) platforms Excellent communication, written and organizational skills (i.e., ability to prioritize a number of tasks of varying complexity), along with problem solving, and conflict resolution Ability to motivate and collaborate with other functional teams and/or departments as necessary Ability to work independently, take initiative, and meet TSN goals for study projects within timelines and budget requirements Able to function in an environment where multiple competing tasks occur Education and Experience: Bachelor's degree or equivalent combination of education and/or experience in science or health-related field 2 years of experience in clinical research in the medical device and/or pharmaceutical industry with IDE and/or IND experience preferred Clinical research experience outside the U.S. is helpful but not required Working knowledge of Food and Drug Administration (FDA) regulations and GCP guidelines Work Environment: Prolonged periods of sitting at a desk and working on a computer Required to use hands/fingers to type and handle materials Must be able to lift up to 15 pounds at times Work Authorization: Applicants must be legally authorized to work in the United States. We are unable to provide visa sponsorship now or in the future. EEO Statement: The Spine Network is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.?
$40k-58k yearly est. 12d ago
Senior Clinical Trial Associate
Verastem 3.7
Boston, MA jobs
Company Profile: At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more at ***************** Summary: Responsible for assisting and providing support to the members of the clinical operations project team to facilitate the operational execution of the clinical trial processes in accordance with regulatory guidelines and ICH/GCP standards. Responsibilities: · Manages trial-related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users. · Uploads and reviews TMF documents for completeness, accuracy and compliance with protocol and applicable regulations, standard operating procedures and best practices. · Performs quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required documents within the TMF. · Audits TMFs and resolves descrepancies with minimal supervision. · Creates and maintains internal folders on company share drive(s). Manages study investigator CDAs, contract approval and purchase order creation. · Coordinates cross function project team meetings with Clinical Project Manager and assists in preparation of agendas, minutes and tracking of action items. · Assists in the creation of study materials, including but not limited to documents, presentations and reports. · Supports CPM to established and maintain the tracking tools for project metrics such as site activation, patient enrollment and site contacts. · Reviews and assists in the collection of essential documents for completeness and compliance with SOPs, the protocol and appropriate regulations. · Creates and reviews IMP release packet prior to initiation; review background information of potential new sites (e.g. debarment check, Inspection history, etc). · Assists study team and sites with preparation for audits/inspections. · Participates in inter-departmental workgroups to create or enhance processes. · May participate in the training of CRO teams, investigators and study team members. · May serve as the point of contact for vendors and oversee selected vendor activities. · May be responsible for updating Clintrials.gov. · Performs administrative tasks to support team members with clinical trial execution, as needed. Qualifications: · Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required. · Minimum of 4 years' experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor). · Relevant experience in clinical research or related field. · Adequate Good Clinical Practice training. · General knowledge of guidelines governing clinical research. · Comfortable with technology and ability to learn new systems quickly. · Experienced with Veeva TMF. · Strong knowledge of MS Word, Excel, PowerPoint and Outlook. · Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines. · Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization. · Must be able to work in a fast-paced environment with demonstrated ability to work on multiple competing tasks and demands. · Ability to work successfully within a cross-functional team.
$110k-147k yearly est. 60d+ ago
Clinical Research Coordinator 1 - San Antonio, TX - Office Based
Worldwide Clinical Trials 4.4
San Antonio, TX jobs
Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Clinical Research Coordinator 1 does at Worldwide The Clinical Research Coordinator 1, under the guidance of the Clinical Research Coordinator Supervisor, and each clinical trial's Principal Investigator, is responsible for assisting with assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines and ICH guidelines as applicable. What you will do Reviews study protocol. Performs quality checks on source documents specific to the study. Ensure that prepose procedures required for study prior to each dose are completed and remains present for subject monitoring post-dose. Provide subjects instructions at check-in and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events. Ensure randomization procedures are completed per study requirement. Obtain and document adverse event data on appropriate forms. Assure quality and completeness of source documents and Case Report Forms (CRFs) collected during the course of the study. What you will bring to the role Excellent written and oral communication skills. Basic computer knowledge and applications required for generation of business correspondence and preparation of regulatory and other study documents. Strong interpersonal skills. Excellent attention to detail. Exceptional organizational skills. Ability to set and meet deadlines with high quality work. Your experience Required: Bachelor's Degree (preferably in the field of Life Sciences or Health) or 1-2 years of clinical research experience. Preferred: 2 to 5 years of clinical research experience. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
$42k-61k yearly est. Auto-Apply 60d+ ago
Clinical Research Assistant - David Turbay MD PLLC
Elligo Health Research Inc. 3.7
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. 22d ago
Clinical Research Coordinator
Wake Research 3.7
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. 30d ago
Clinical Research Coordinator
Wake Research 3.7
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 Assistant
Retina Consultants of Houston 4.0
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 4.0
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 4.0
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 4d ago
Clinical Research Assistant
Retina Consultants of Houston 4.0
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 4.0
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