Post Job

Clinical Research Associate Jobs in Red Oak, TX

- 143 Jobs
All
Clinical Research Associate
Clinical Research Coordinator
Clinical Research Assistant
Clinical Coordinator
Clinical Associate
Study Coordinator
Research Coordinator
Clinical Research Specialist
Research Nurse
Clinical Researcher
Clinical Research Scientist
Senior Clinical Research Associate
Clinical Trials Specialist
  • Clinical Research Regulatory Coordinator

    Medix™ 4.5company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Responsibilities: Prepares and submits regulatory documents to IRBs and sponsors independently. Maintains regulatory binders electronically and in the CTMS in compliance with regulations governing clinical research GCP and site SOPs. Drafts and revises ICFs, site-specific regulatory forms, and other regulatory documents. Coordinates responses to IRB queries and sponsor requests for information. Serves as the primary regulatory point of contact for assigned studies. Participates in internal audits and regulatory reviews. Supports and mentors Regulatory Assistants in task completion and training. Monitors document version control and conduct routine regulatory QC checks. Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required. Performs other miscellaneous job-related duties as assigned by their manager. Requirements: Associate or bachelor's degree required, preferably in life sciences or health-related field. 3-5 years of clinical research regulatory affairs experience.
    $41k-58k yearly est. 8d ago
  • Clinical Research Associate, Sponsor Dedicated

    Iqvia 4.7company rating

    Clinical Research Associate Job 18 miles from Red Oak

    , you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree Degree in scientific discipline or health care preferred. Req - Requires at least 2 years of year of on-site monitoring experience. Req - Equivalent combination of education, training and experience may be accepted in lieu of degree. Req - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Written and verbal communication skills including good command of English language. - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
    $71.9k-189k yearly 45d ago
  • Weights and Research Coordinator

    R+L Carriers 4.3company rating

    Clinical Research Associate Job 25 miles from Red Oak

    Weights and Research Coordinator, $60,000.00 to $70,000.00 Full-Time Monday-Friday, 4pm-2am Earn 1 week of vacation after 90 days of employment Come and experience the difference with R+L Carriers R+L Carriers has immediate opportunities for a W&R Coordinator at our Irving, TX location. To Ensure R&L Carriers receives the appropriate revenue on shipments, the W&R Coordinator will review shipments as they pass across their respective docks to verify the accuracy of the actual class of the shipment compared to that of the bill of lading information. Requirements: * Any type of LTL experience preferred but not required * Ability to self-motivate and self-manage * Willingness to learn * Analytical skills * Computer proficiency * Able to work in a fast-paced environment Excellent Benefits R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC. Click here **************************** R+L Carriers has immediate opportunities for a W&R Coordinator at our Irving, TX location.
    $60k-70k yearly 12d ago
  • Senior Clinical Research Associate (level dependent on experience)

    CTI Clinical Trial Services 3.7company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
    $67k-104k yearly est. 60d+ ago
  • Research Scientist, Clinical and Translational Research

    Caris Life Sciences 4.4company rating

    Clinical Research Associate Job 25 miles from Red Oak

    **At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.** We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: _"What would I do if this patient were my mom?"_ That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. **Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.** **Position summary** Looking for highly-trained and passionate research scientists to lead research projects to leverage the world's largest cancer database of comprehensive and deep molecular data and clinical outcome to advance precision medicine in oncology. The Research Scientist, Clinical and Translational Research (CTR) will manage a team of scientist and/or analysts working closely with numerous leading biopharma partners and a network (Caris Precision Oncology Alliance) of leading cancer institutions and centers. Research results will be presented at major conferences and published in top clinical oncology journals, and leveraged to inform critical elements of drug development including biomarker strategy, cohort builds and assessment, and treatment patterns in patient populations of interest. The CTR will develop and manage strategic plans for functional areas or significant projects. Help to aligns policies, products, and development efforts with strategies. **Job responsibilities:** + Carry out assigned research projects, initiated either internally or externally as collaborative efforts; apply knowledge of cancer biology, molecular genetics, and clinical oncology to ensure the quality and novelty of the projects. + Work under the supervision of CTR leadership for study design, planning and data interpretation; work in close collaboration and synergy with data scientists on data extraction and perform the most appropriate statistical analysis. + Communicate effectively with external stakeholders including POA collaborators, biopharma partners and/or company leadership and to formulate and refine research ideas and proposals to ensure the scientific originality and maximum impact to advancing precision oncology. + Work closely with cross-functional teams internally or externally, including but not limited to data science team, POA Strategy team, Biopharma & business Development, Medical Affairs scientists, Bioinformatics, Molecular Science Liaison Team, Molecular Geneticists, pathologists, and statisticians. + Draft manuscripts, conference abstracts, posters, and/or presentation slides for various audiences + Work collaboratively with internal/external researchers on editing drafts until finalization and publication. + Be familiar with the CMI reports, including the tests and evidence review process, in order to align research projects with the overall goal of the company. + Stay abreast of the fast emerging scientific and clinical literature in the field of clinical oncology, share with the CTR team and medical affairs team knowledge and progress in the space. **Required Qualifications:** + Ph.D. in computational biology, statistics, bioinformatics, cancer biology, biochemistry, molecular and cellular biology or biostatistics or equivalent training and experience required. + Extensive knowledge in cancer biology of solid tumors, deep understanding of molecular genetics and familiarity with targeted and immune therapies in cancer treatment required. + Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use. **Preferred Qualifications:** + Extensive knowledge in cancer, deep understanding of molecular genetics and familiarity with targeted and immune therapies in cancer treatment required. + Previous research experience in the molecular diagnostic field of oncology is preferred. Strong background in biostatistics or data science is preferred. + Understanding of clinical development and/or how translational research can impact decision making to the oncology asset journey is preferred. + Excellent written and oral communication skills are required. + Proven ability to work independently as well as in a team + Strong attention to detail, well-organized; proven ability to prioritize multiple projects and to meet strict deadlines. + Proficient with statistics and familiarity with statistical software (Python and R preferred) **Physical Demands:** + None **Training** + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + Travel required: minimal. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.
    $56k-83k yearly est. 19d ago
  • Trial Experience Specialist - Sales - Spanish Billigual

    Highlevel, Inc. 4.1company rating

    Clinical Research Associate Job 18 miles from Red Oak

    About Us HighLevel is a cloud-based, all-in-one white-label marketing and sales platform that empowers marketing agencies, entrepreneurs, and businesses to elevate their digital presence and drive growth. We are proud to support a global and growing community of over 2 million businesses, from marketing agencies to entrepreneurs to small businesses and beyond. Our platform empowers users across industries to streamline operations, drive growth, and crush their goals. HighLevel processes over 15 billion API hits and handles more than 2.5 billion message events every day. Our platform manages 470 terabytes of data distributed across five databases, operates with a network of over 250 microservices, and supports over 1 million domain names. Our People With over 1,500 team members across 15+ countries, we operate in a global, remote-first environment. We are building more than software; we are building a global community rooted in creativity, collaboration, and impact. We take pride in cultivating a culture where innovation thrives, ideas are celebrated, and people come first, no matter where they call home. Our Impact Every month, our platform powers over 1.5 billion messages, helps generate over 200 million leads, and facilitates over 20 million conversations for the more than 2 million businesses we serve. Behind those numbers are real people growing their companies, connecting with customers, and making their mark - and we get to help make that happen Learn more about us on our YouTube Channel or Blog Posts Who You Are: You are searching for your opportunity to impact the experience of SaaS customers at the very beginning of their customer journey. Providing them with world class engagement the moment they begin a trial with the HighLevel platform. Your strategic and creative thinking skills allow you to meet the demands of our prospective customers by intelligently speaking to the solutions HighLevel offers and how it will benefit their business. You'll flourish in our dynamic performance based atmosphere that gives you autonomy to work independently on some projects and collaborate with various departments on others. Tie it all together with an "all hands on deck" attitude, excellent communication and time management skills and this is the job for you! To be successful in this role, you will demonstrate best in class service and be a subject matter expert on how the HighLevel platform fits into their business strategy and success. You will have experience working in a high-performance, high-accountability environment. You are comfortable switching gears quickly, and passionate about helping people. Your excellent communication skills and working knowledge of the SaaS/Marketing landscape will serve you well. Roles, Responsibilities & Requirements * What You'll Be Doing: * Identify, engage and nurture new customer relationships * Align solutions to the customer's goals, needs and objectives * Develop strong rapport with a pipeline of new business customers through inbound customer engagement that drives maximum trial conversion * Learn, understand, and be able to articulate and showcase the Value Proposition (i.e. Capture, Nurture, Close) of the HighLevel platform to impact trial to paid metrics * Conduct consultative trial engagement efforts for HighLevel's sales process (via Zoom) * Engage through additional communication channels such as phone, SMS, email, ticketed & live Zoom support driving them to the best trial experience for their business with the end goal to get them to become a paying client * Collaborate with customers and cross-functional teams to identify compelling solutions * Exercise judgment in developing and implementing methods and techniques to obtain desired results while following industry best practices * Provide technical support to customers, if needed (during trial period, the more engagement opportunities, the more opportunities for conversions) * Other duties may be assigned and/or modified as business needs dictate What You'll Bring: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required Experience/Education/Certifications Required:Bachelor's Degree or equivalent SaaS experience is strongly preferred 0-2 Years of previous customer service experience or a relevant role - even better if you've been in a Sales Development or Technical Sales roleA strong technical aptitude to help our users succeed with the HighLevel software Experience with technical documentation and presentation skills preferred Working knowledge of topics such as CRM, Marketing Automation tools, Social Media Management, Social Media Advertising, Website/Funnel Building, and SEOExperience working with and or ability to learn the use of various CRM platforms and communication systems Working knowledge of the following applications strongly preferred: Google Suite, Zoom, Slack, Facebook, Instagram, LinkedIn and other social media Strong time management, organizational skills and interpersonal communication skills, both verbal and written Self-motivated to maintain regular contact with customers, management, and peers You can translate technical ideas for non-technical audiences Demonstrable critical thinking, communication, and creative problem-solving skills Ability to learn new complex software platforms quickly Self-starter, positive attitude, ability to continuously develop and adapt to a growing team Highly organized to manage and prioritize several different responsibilities at any given time Equal Employment Opportunity Information The company is an Equal Opportunity Employer. As an employer subject to affirmative action regulations, we invite you to voluntarily provide the following demographic information. This information is used solely for compliance with government recordkeeping, reporting, and other legal requirements. Providing this information is voluntary and refusal to do so will not affect your application status. This data will be kept separate from your application and will not be used in the hiring decision. #LI-Remote #LI-VP1
    $58k-93k yearly est. 60d+ ago
  • Study Coordinator

    McKesson Corporation 4.6company rating

    Clinical Research Associate Job 18 miles from Red Oak

    It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling, and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsors and study team. * You will lead the execution of trials for the research team * You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out * You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians * You will verify study procedures are performed within the protocol specified window * You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff * You will present in weekly protocol meeting to investigators, research staff, and management * You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria * You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments * You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) * You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes * You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions * You will ensure pharmacy has Investigative Product and supplies * You will interface with laboratory technician for lab kits and processing * You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations * You will participate in monitor visits for each assigned trial at each monitoring visit * You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items * You will review source documentation and queries for missing documentation * You will collect, complete, and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe * You will maintain case report forms tracking management database * You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance * You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events * You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning * You will review and responds to audit findings and escalates issues * You will maintain and archive study documentation and correspondence per company policy * You will report patient visit and data entry information in financial tracking system. * You will provide required metrics to leadership * You will initiate improvements to enhance the efficiency, and the quality of the work performed on assigned projects * You will adhere to professional standards and SOP's established for clinical research * You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: * An understanding of clinical trial data. * Knowledge of FDA guidelines and GCP is required. * The ability to work independently in a fast-paced environment. * Interpersonal skills, detailed-oriented and meticulous. * Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel * Bachelor's degree is preferred * At least one year of experience in healthcare, research, or other science related field * At least one year of experience planning and managing clinical trial process About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $41k-55k yearly est. 20d ago
  • Clinical Research Regulatory Specialist

    General Accounts

    Clinical Research Associate Job 22 miles from Red Oak

    Benefits: Competitive salary Health insurance Paid time off Tuition assistance Vision insurance SMS Clinical Research is currently seeking candidates for a Clinical Research Regulatory Specialist for their office in Mesquite TX JOB SUMMARY The Regulatory Specialist is responsible for ensuring clinical research studies comply with all applicable regulatory guidelines, including those set by the FDA and ethics committees, by managing regulatory submissions, coordinating with study teams, and maintaining accurate documentation throughout the clinical trial process, acting as a key liaison between researchers, sponsors, and regulatory agencies; their primary focus is to facilitate study start-up, conduct, and closure while adhering to all regulatory standards. ESSENTIAL JOB DUTIES: Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for research project goals. Manages and maintains electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations. Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed. Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems. Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, ALCOA guidelines, patient confidentiality (HIPAA) and any other applicable laws. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial startup and progress. Performs other related duties as assigned. OTHER SKILLS/ABILITIES: Regulatory experience required; paper and electronic. Willingness to work in a fast-paced environment where processes change and improve continually. Able to function independently without constant supervision and adapt to change. Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach. Ability to effectively devote keen and acute attention to detail. Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet Browsers Professional and highly motivated “self-starter” with the ability to exercise initiative. Excellent task management and prioritization skills. Strong verbal and interpersonal skills. Excellent follow up skill. EDUCATION AND EXPERIENCE: · Minimum education is a Bachelor's degree, or an equivalent combination of experience, education and training. · Knowledge of clinical research practices. If you meet the above qualifications, please submit your resume for immediate consideration.
    $40k-61k yearly est. 4d ago
  • Clinical Research Regulatory Specialist

    Salma Mazhar Md Pa

    Clinical Research Associate Job 22 miles from Red Oak

    Job DescriptionBenefits: Competitive salary Health insurance Paid time off Tuition assistance Vision insurance SMS Clinical Research is currently seeking candidates for a Clinical Research Regulatory Specialist for their office in Mesquite TX JOB SUMMARY The Regulatory Specialist is responsible for ensuring clinical research studies comply with all applicable regulatory guidelines, including those set by the FDA and ethics committees, by managing regulatory submissions, coordinating with study teams, and maintaining accurate documentation throughout the clinical trial process, acting as a key liaison between researchers, sponsors, and regulatory agencies; their primary focus is to facilitate study start-up, conduct, and closure while adhering to all regulatory standards. ESSENTIAL JOB DUTIES: Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for research project goals. Manages and maintains electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations. Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed. Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems. Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, ALCOA guidelines, patient confidentiality (HIPAA) and any other applicable laws. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial startup and progress. Performs other related duties as assigned. OTHER SKILLS/ABILITIES: Regulatory experience required; paper and electronic. Willingness to work in a fast-paced environment where processes change and improve continually. Able to function independently without constant supervision and adapt to change. Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach. Ability to effectively devote keen and acute attention to detail. Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet Browsers Professional and highly motivated self-starter with the ability to exercise initiative. Excellent task management and prioritization skills. Strong verbal and interpersonal skills. Excellent follow up skill. EDUCATION AND EXPERIENCE: Minimum education is a Bachelor's degree, or an equivalent combination of experience, education and training. Knowledge of clinical research practices. If you meet the above qualifications, please submit your resume for immediate consideration.
    $40k-61k yearly est. 26d ago
  • Clinical Research Coord 2 Cardiology

    Baylor Scott & White Health 4.5company rating

    Clinical Research Associate Job 35 miles from Red Oak

    The Clinical Research Coordinator 2 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines. **ESSENTIAL FUNCTIONS OF THE ROLE** + Reviews new protocols and other materials provided by Study Sponsors, and provides input to the PIs and clinical managers, as applicable, regarding clinical and research issues in order to establish financial and clinical feasibility. + Coordinates the implementation of various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors, providing in-service education for healthcare professionals, and working with Pharmacy to ensure a smooth project flow. + Reports to the Institutional Review Board (IRB), completing IRB review reports and assisting with drug accountability. + Develops research study budgets for new clinical trials and assists in the completion of all applicable research billing compliance procedures. + Coordinates study-monitoring visits. Completes and submits monthly invoices for applicable patient care charges covered by funded research studies. + Participates in data testing, writing and submitting manuscripts and abstracts for publication, as appropriate. + Develops, implements and administers Clinical Research policies and procedures. + Unites with quality audits. **KEY SUCCESS FACTORS** + Research certification and other certifications per specialty area preferred. + Proven written and oral communication skills. + Proven computer skills, including Microsoft Office. + Ability to manage time reactive projects in order to meet deadlines. + Exceptional ability to establish and maintain effective working relationships. + Ability to autonomously operationalize and coordinate large or complex studies from start to finish. + Ability to autonomously work across functional departments within BSWRI. + Proven critical thinking and problem-solving skills; ability to troubleshoot study challenges. + Ability to work within a team, including training of junior staff. **BENEFITS** Our competitive benefits package includes the following. Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include: + Immediate eligibility for health and welfare benefits + 401(k) savings plan with dollar-for-dollar match up to 5% + Tuition Reimbursement + PTO accrual beginning Day 1 Note: Benefits may vary based upon position type and/or level **QUALIFICATIONS** + **EDUCATION** - Bachelor's or 4 years of work experience above the minimum qualification + **EXPERIENCE** - 2 Years of Experience + **CERTIFICATION/LICENSE/REGISTRATION** - Cert Clinical Research Assoc (CCRA), Cert Clinical Research Coord (CCRC), CCRP-Cert Clnl Research Prof (CCRP-RES): Research Certification and/or certification that pertains to particular work area must be obtained within one year. As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
    $48k-70k yearly est. 28d ago
  • Research Study Coordinator, School of Public Health

    University of Texas Southwestern Medical Center 4.8company rating

    Clinical Research Associate Job 18 miles from Red Oak

    WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY Works under general supervision to coordinate research projects. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: * PPO medical plan, available day one at no cost for full-time employee-only coverage * 100% coverage for preventive healthcare-no copay * Paid Time Off, available day one * Retirement Programs through the Teacher Retirement System of Texas (TRS) * Paid Parental Leave Benefit * Wellness programs * Tuition Reimbursement * Public Service Loan Forgiveness (PSLF) Qualified Employer * Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION Required * Education Master's Degree In related field or Bachelor's Degree In related field * Experience 1 year Research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research with Master's Degree or 3 years Research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research with Bachelor's Degree. JOB DUTIES * Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies. * Coordinates all regulatory aspects, such as preparing safety reports, adverse events, FDA compliance, drug company monitoring, and laboratory standards; maintains databases related to these regulatory aspects. * Coordinates aggregation and maintenance of local and national research data required to ascertain and identify research study outcomes; oversees and may perform entry of research data, coding, retrievals, adjustments, additions, and computer backups. * May develop and monitor budgets; negotiates participant rates; approves expenditures; pays invoices; reconciles accounts associated with studies. * Develops and prepares statistical research reports, charts, and graphs as required during research studies. * Assists in design of research survey forms to capture required subject information; interviews research study subjects and/or family members to gather research study information. * Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper informed consent; tracks subjects' information from multiple projects. Prepares informed consent forms for subjects' families. * Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects. * Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies. Informs Institutional Review Board of amendments to research studies; prepares protocols and detailed summaries in lay terms of any new research study. * May provide full supervision to personnel of lower grade. * Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. * Performs other duties as assigned. SECURITY AND EEO STATEMENT Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 113.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position. EEO Statement UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Benefits UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: * PPO medical plan, available day one at no cost for full-time employee-only coverage * 100% coverage for preventive healthcare - no copay * Paid Time Off, available day one * Retirement Programs through the Teacher Retirement System of Texas (TRS) * Paid Parental Leave Benefit * Wellness programs * Tuition Reimbursement * Public Service Loan Forgiveness (PSLF) Qualified Employer * Learn more about these and other UTSW employee benefits!
    $45k-59k yearly est. 12d ago
  • Research Coordinator--TRAUMA

    Methodist Health System 4.7company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Your Job: This job will support of all phases of the research process in support of Trauma and General Surgery research protocols. The responsibilities will include support of protocol and manuscript development process, coordination of data collection, patient follow-up and tracking, and data entry. This position supports the mission, vision, values, and strategic goals of Methodist Health System. Your Job Requirements: - Bachelor's degree (B.A., B.S.) or higher in appropriate discipline is required - Desire to contribute to improved evidence based practices for the care of the traumatically injured patient - Experience with medical terminology and a working knowledge of human anatomy - Firm knowledge of Microsoft Office Suite (Word, Excel, and PowerPoint) - Experience with statistical methods preferred - Bilingual (Spanish & English) at professional or better preferred Your Job Responsibilities: - Work closely with the research scientist to support the Trauma Medical Director and Surgical Residency Program Director as they work together to meet the requirements of being a Level I Trauma Center. - Collect data on prospective studies and conduct chart review or data extraction for retrospective studies with the assistance of our EMR/, development of registry queries, or database refinement - Screen patients for eligibility, consent them for participation and provide necessary follow-up including phone calls for follow-ups for various studies. - Assist the research scientist in preparing the data for analysis, formatting and completing study submission for publication to appropriate organizations - Compile IRB applications for PI initiated studies including literature review, data assimilation, and attaining relevant signatures. - Ensure regulatory compliance with completion of all relevant documents including continuing review applications, reporting of adverse events (or severe adverse events) etc. - Setup Methodist Dallas Medical Center or other sites within the system for study initiation, data collection and execution. This may include travel to other sites for collaboration with other coordinators at other sites. - Assumes technical responsibilities for specimen collections including blood samples, centrifugation, shipping of samples etc. - Completes all applicable research billing in compliance with procedures - Ensures all study documents are complete and the records are retained per federal, state and institutional standards Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by _Modern Healthcare_ , Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned: + TIME magazine Best Companies for Future Leaders, 2025 + Great Place to Work Certified, 2025 + Glassdoor Best Places to Work, 2025 + PressGaney HX Pinnacle of Excellence Award, 2024 + PressGaney HX Guardian of Excellence Award, 2024 + PressGaney HX Health System of the Year, 2024 Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by _Modern Healthcare_ , Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned: + Magnet designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers + 150 Top Places to Work in Healthcare by _Becker's Hospital Review_ , 2023 + Top 10 Military Friendly Employer, Gold Designation, 2023 + Top 10 Military Spouse Friendly Employer, 2023 Equal Opportunity Employer It is the policy of Methodist Health System (MHS) to select, develop, and promote employees based on individual ability and job performance. It has been, and will continue to be, the policy of MHS to provide equal employment opportunity to all people in all aspects of employer-employee relations without discrimination because of race, color, religion, national origin, age, sex, sexual orientation, gender expression, disability, marital status, genetic information or ancestry. This policy affects decisions including, but not limited to, an employee's compensation, benefits, terms and conditions of employment, opportunities for promotion, training, development, transfer all other privileges of employment. MHS is committed to maintain a working environment free of intimidation, workplace discrimination and harassment. Retaliation or attempted retaliatory behavior that occurs as a result of an employee's exercise of their rights under this policy or any other statutorily protected right is strictly prohibited and will be grounds for disciplinary action.
    $47k-65k yearly est. 56d ago
  • Research Study Coordinator, School of Public Health

    Utsw

    Clinical Research Associate Job 18 miles from Red Oak

    Research Study Coordinator, School of Public Health - (868164) Description WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY Works under general supervision to coordinate research projects. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: PPO medical plan, available day one at no cost for full-time employee-only coverage 100% coverage for preventive healthcare-no copay Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave Benefit Wellness programs Tuition Reimbursement Public Service Loan Forgiveness (PSLF) Qualified Employer Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION RequiredEducationMaster's Degree In related field or Bachelor's Degree In related field Experience1 year Research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research with Master's Degree or 3 years Research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research with Bachelor's Degree. JOB DUTIES Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies. Coordinates all regulatory aspects, such as preparing safety reports, adverse events, FDA compliance, drug company monitoring, and laboratory standards; maintains databases related to these regulatory aspects. Coordinates aggregation and maintenance of local and national research data required to ascertain and identify research study outcomes; oversees and may perform entry of research data, coding, retrievals, adjustments, additions, and computer backups. May develop and monitor budgets; negotiates participant rates; approves expenditures; pays invoices; reconciles accounts associated with studies. Develops and prepares statistical research reports, charts, and graphs as required during research studies. Assists in design of research survey forms to capture required subject information; interviews research study subjects and/or family members to gather research study information. Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper informed consent; tracks subjects' information from multiple projects. Prepares informed consent forms for subjects' families. Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects. Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies. Informs Institutional Review Board of amendments to research studies; prepares protocols and detailed summaries in lay terms of any new research study. May provide full supervision to personnel of lower grade. Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. SECURITY AND EEO STATEMENTSecurity This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 113.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position. EEO Statement UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Research & LaboratoryOrganization: 260010 - SPH-EpidemiologySchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jun 3, 2025, 6:03:57 PM
    $38k-56k yearly est. 1d ago
  • Study Coordinator

    JSC SCRI Holdings

    Clinical Research Associate Job 18 miles from Red Oak

    It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling, and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsors and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete, and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will report patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency, and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast-paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor's degree is preferred At least one year of experience in healthcare, research, or other science related field At least one year of experience planning and managing clinical trial process About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $38k-56k yearly est. 17d ago
  • Clinical Research Coordinator

    Dean's Professional Services 4.1company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Job Description Dean's Professional Services is now hiring a Clinical Research Coordinator Pay Rate: $34/hr Schedule: Monday - Friday | 7:00 AM - 4:00 PM Dean's Professional Services is seeking an experienced Clinical Research Coordinator to support clinical trials at a respected healthcare facility in Dallas. This role involves coordinating multiple research protocols, ensuring regulatory compliance, and acting as a liaison between investigators, sponsors, and site teams. Key Responsibilities: Manage daily operations of multiple clinical research studies Coordinate with investigators, sponsors, and internal departments Screen and enroll study participants, ensuring proper informed consent Maintain accurate and timely data collection and entry Track study supplies, shipments, and drug/device accountability Monitor for protocol compliance and report adverse events as needed Attend sponsor meetings, audits, and required study trainings Qualifications: Bachelor's degree required Minimum of 2 years of relevant clinical research experience Certified Clinical Research Coordinator (preferred) Skills & Abilities: Strong organizational and time-management skills Excellent written and verbal communication Attention to detail and ability to manage multiple priorities Experience with electronic data capture systems Comfortable with clinical procedures such as phlebotomy and ECG (training provided if needed) Professional, self-motivated, and team-oriented Dean's Professional Services is a national, award-winning staffing solutions firm. Since 1993, DPS has placed over 45,000 professionals across the nation. We work with our clients to provide placement opportunities that match your skill, experience, and personality. For more information please visit
    $34 hourly 5d ago
  • Assistant Clinical Research

    Metrocare Services 4.2company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Job Details ACER - 1345 River Bend Drive, Suite 200 - Dallas, TX Part Time Bachelors Travel within DFW Metroplex ClinicalDescription Are you looking for a purpose-driven career? At Metrocare, we serve our neighbors with developmental or mental health challenges by helping them find lives that are meaningful and satisfying. Metrocare is the largest provider of mental health, developmental disability and permanent supported housing services in Dallas County serving over 50,000 children, teens and adults annually. For over 55 years, Metrocare has provided a broad array of services from mental health care, primary care, services for veterans and their loved ones, accessible pharmacies, homeless outreach, and supportive social services. Metrocare provides specialty mental health services to over 10,000 children and teens and has numerous programs for babies, children and adults with disabilities, including Early Childhood Intervention, Flourishing Families, Nurturing Parenting, Supported Employment and two specialty autism clinics in Dallas and DeSoto. In conjunction with clinical care, Metrocare's Altshuler Center for Education & Research is transforming the community mental health landscape of North Texas through workforce development focused on innovative partnerships and exceptional trauma-informed training. The Clinical Research Assistant is responsible for supporting our clinical education and research operations under the guidance of licensed clinicians and doctoral-level researchers. This position will assist with all research projects conducted within ACER. The prospective candidates must demonstrate knowledge and skills in data analysis, complex statistical analyses, and communicating visual research results. Research duties reflect substantial variety and complexity. *DFW APPLICANTS ONLY* HOURS OF RESPONSIBILITY: 20 hours a week; Monday - Friday 8 am - 5 pm, schedule is negotiable during the noted hours of operation. ESSENTIAL DUTIES AND RESPONSIBILITIES: The essential functions listed here are representative of those that must be met to successfully perform the job. Assist in the coordination and execution of clinical research protocols. Coordinate day-to-day operations of clinical research studies. Recruit, screen, and enroll eligible research participants. Obtain informed consent and ensure participants understand study procedures. Maintain accurate and confidential participant records and research documentation. Enter, review, and update data in electronic data capture systems. Prepare study materials and assist with regulatory submissions and compliance. Support communication between investigators, clinical staff, and research teams. Schedule and manage participant visits, including follow-ups and reminders. Assist with audit readiness and protocol adherence. Perform preliminary and exploratory statistical analyses using SPSS, SAS, or R. Clean, manage, and transform datasets to support analytical readiness. Create data visualizations, summaries, and tables for research publications and presentations. Collaborate with research scientists to interpret data and test hypotheses. Draft non-technical summaries of research findings for newsletters, social media, and Metrocare's website. Monitor ACER Research Inbox and respond to general inquiries. Create infographics (e.g., flowcharts) and standard operating procedures (SOPs) that articulate research protocol. Assist in developing components of clinical education presentations to be used at staff continuing education seminars (e.g., annotated bibliographies, summary reports, handouts, surveys). Assist in manuscript preparation, conference submissions, and technical reports. Support computational modeling and digital tools used in research protocols. Performs other duties as assigned. COMPETENCIES: The competencies listed here are representative of those that must be met to successfully perform the essential functions of this job. Conducts job responsibilities in accordance with the ethical standards of conduct, state contract, appropriate professional standards and applicable state/federal laws. Analytical skills, professional acumen, business ethics, thorough understanding of continuous improvement processes, problem solving, respect for confidentiality, and excellent communication skills. Effective verbal and written communication skills. Excellent organizational skills with the ability to prioritize workflow and meet deadlines. Ability to handle multiple tasks and special projects simultaneously. Able to work autonomously with minimal or no supervision. Able to maintain a high level of professionalism and confidentiality. Ability to complete data analysis, complex statistical analyses, and communicate visual research results with minimal assistance. Ability to Prepare datasets for analysis by addressing missing values, outliers, and normalization. Experience conducting complex statistical analyses using tools like SPSS, SAS, or R. Proficiency using Excel, Tableau, or Power BI Proficiency with machine learning models using a programming language (e.g., Python). QUALIFICATIONS EDUCATION AND EXPERIENCE: Required: Bachelor's degree Actively pursuing a master's degree in Data Analytics, Computer Science, Mathematics, or a related field from an accredited college/university or recently graduated (within the last 2 years) Completed at least 2 graduate-level computational courses. Cumulative GPA of 3.0 or higher. DRIVING REQUIRED: Yes MATHEMATICAL SKILLS: Basic math skills required. Ability to work with reports and numbers. Ability to calculate moderately complex figures and amounts to accurately report activities and budgets. REASONING ABILITY: Ability to apply common sense understanding to carry out simple one or two-step instructions. Ability to deal with standardized situations with only occasional or no variables. COMPUTER SKILLS: Use computer, printer, and software programs necessary to the position (i.e., Word, Excel, Outlook, and PowerPoint). Ability to utilize Internet for resources. CERTIFICATIONS, LICENSES, REGISTRATIONS: Current State of Texas Driver License or if you live in another state, must be currently licensed in that state. If licensed in another state, must obtain a Texas Driver License within three (3) months of employment. Liability insurance is required if an employee will operate a personal vehicle on Center property or for Center business. Must be insurable by Center's liability carrier if employee operates a Center vehicle or drives personal car on Center business. Must have an acceptable driving record. Metrocare couldn't have a great employee-first culture without great benefits. That's why we offer a competitive salary, exceptional training and an outstanding benefits package: Medical/Dental/Vision Paid Leave Paid Holidays Employee Assistance Program Free Mental Healthcare Retirement Plan, including employer matching Health Savings Account, including employer matching Professional Development Allowance up to $2000 per year Bilingual Stipend - up to 6% of the base salary Many other benefits Equal Employment Opportunity Em
    $33k-44k yearly est. 24d ago
  • Clinic Experience Associate

    Kleiman Evangelista Eye Center 3.0company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Are you someone who cares about patients? Who loves solving problems? With great communication skills and attention to detail. If so, we would love to have you as part of our family. Kleiman Evangelista is looking for a full time Front Desk Receptionist for our Clinic, and we are wiling to train! Who we are… Kleiman Evangelista Eye Centers of Texas is a full-service, medical ophthalmology provider offering comprehensive eye care, LASIK, vision correction, and cataract procedures in the Dallas Fort Worth Metroplex and beyond. With nearly 40 years of experience, Kleiman Evangelista's team of board-certified doctors is committed to delivering the highest-quality eye care in Texas. What we do… Our mission is to improve people's lives through better vision and outstanding patient experiences. What you will do… * Greet patients as they arrive at the office in a friendly and professional manner. * Answer, assist, and direct all incoming telephone calls to appropriate parties in a professional, courteous and timely manner. * Answer general patient questions about their procedures and understand where to refer questions that are beyond their scope of knowledge. * Quote and discuss surgical fees, service fees, co-pays, payment policies and financing options with patients. * Check patients in and out and schedule any needed appointments. * Bill out visits through insurance, collect payments, and enter correct CPT/ ICD-10 codes to ledger * Assist with end of day counts and prepare accurate daily deposits What we require… * Two years of patient/customer care experience (or equivalent customer related ability) * Proficient in Microsoft Office, specifically Excel, Word, and PowerPoint * Excellent oral and written communication skills * Exceptional customer relationship skills What we offer… * Medical * Dental * Vision Discounts * Educational reimbursements for COA OR COT certifications * 401(k) with generous company match and 100% vesting upon contribution * Life Insurance * Short Term & Long-Term Disability options * Employee Assistance Program * Generous time off plans and company paid holidays * Uniform allowance Icon Eyecare provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Qualifications
    $88k-145k yearly est. 31d ago
  • Clinical Research Coordinator

    System One 4.6company rating

    Clinical Research Associate Job 18 miles from Red Oak

    Title: Clinical Research Coordinator Type/Duration: Contract, 6 months Schedule: Monday-Friday, core daytime business hours based on clinic hours, could have some earlier morning starts Duties and Responsibilities: Duties include but are not limited to: - Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements - Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance - Collects, completes, and enters data into study specific case report forms or electronic data capture systems - Ensures timely and accurate data completion - Collects blood samples and tracks shipments and requests supplies as needed - Implements study-specific communications - Ensures timely adherence to protocol requirements - Responsible for completion of all required documentation - Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications - Communicates all study-related issues to appropriate study colleagues or manager - Apprises principal investigator and management of all study specific medical issues for guidance - Attends study specific meetings as required or asked to do so - Reviews and responds to any monitoring findings and escalates issues Requirements: + Bachelor's degree preferred, 2yr/AS degree is ok with at least 2 years of relevant clinical research experience + Must have at least one solid year as a Clinical Research Coordinator (CRC) working on sponsor-initiated interventional drug and/or device studies + Organizational and prioritizing capabilities + Computer skills with demonstrated abilities using web-based applications, electronic data capture, and MS Word or Excel + Professional communication + Communicate and work effectively with a diverse team of professional + Interpersonal skills, detail-oriented and meticulous + Work independently in a fast pace environment with minimal supervision at off-site facilities Ref: #568-Clinical #LI-KB1 System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
    $40k-57k yearly est. 17d ago
  • Clinical Research Coordinator

    Pinnacle Clinical Research

    Clinical Research Associate Job 18 miles from Red Oak

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager. Duties and Responsibilities: Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment Create and complete study related documents and new study preparation Function as a liaison with pharmaceutical sponsors and external vendors Prepare for study monitor visits (onsite or remote), audit inspections, etc. Respond to internal and external requests for information in a timely manner Perform subject screening and recruitment Contribute to data management for research projects Identify opportunities to improve patient care and satisfaction Conduct patient-facing encounters with compassion, empathy, and thoroughness Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose Obtains and documents adverse event data on appropriate forms Ensure source documents are transcribed to EDC platform per protocol on a timely manner Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate Administration: Ensure that electronic case report forms are completed Create memos, emails, and letters related to study activities Create and maintain reports and/or spreadsheets as requested Ensure that all patient data is entered into the clinical trial management system in a timely manner Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections Responsible for reporting safety information to all regulatory agencies Understand the aspects of Regulatory and IRB requirements for studies Performs quality checks on source documents specific to the study Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Education / Experience: Highschool diploma or general education degree (GED) required Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS Must have strong knowledge of ICH/GCP guidelines Must complete CITI training before interacting with participants and must re-certify every 3 years Must be trained and certified in administration of Fibroscan, training provided during onboarding Must have basic life support (BLS) training, provided during onboarding Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time Strong written and oral communication skills Knowledge of basic medical terminology Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission Comply with the company policies, code of ethics, and guiding values always Proficient in Spanish and English preferred Certificates and Licenses: Valid driver's license and insurance Knowledge, Skills, and Other Abilities: Must be able to effectively communicate with all levels of internal and external contacts Ability to work independently and multi-task in a fast-paced team environment Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients Must be able to work independently and collaborate with a team Ability to interpret clinical research protocols Strong problem-solving and decision-making skills, particularly when under pressure Proactive at identifying, addressing, and solving issues in real time Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids and/or bloodborne pathogens. Personal protective equipment required such as protective eyewear, garments, and gloves. Occasional travel may be required domestic and/or international. Ability to work in an upright and/or stationary position for 6-10 hours per day. Frequent mobility required. Occasionally squatting, kneeling, or bending. Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs. Benefits of working at Pinnacle Clinical Research:
    $38k-56k yearly est. 10d ago
  • Clinical Research Coordinator - Endocrinology experience

    Revival Research Institute

    Clinical Research Associate Job 18 miles from Red Oak

    Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 2-3 year of clinical experience, Ideally would also have Endocrinology experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our position, with room to grow. Our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
    $38k-56k yearly est. 60d+ ago

Learn More About Clinical Research Associate Jobs

How much does a Clinical Research Associate earn in Red Oak, TX?

The average clinical research associate in Red Oak, TX earns between $39,000 and $94,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average Clinical Research Associate Salary In Red Oak, TX

$61,000
Job type you want
Full Time
Part Time
Internship
Temporary