Clinical research associate jobs in Edmond, OK - 33 jobs

Job Title: Unblinded Clinical Research Coordinator Pay Range: Up to $25 per hour Schedule: Monday - Friday, 8:00 AM - 5:00 PM Duration: 90-day contract with potential for extension or conversion to a permanent position based on performance and trial needs. Position Summary: This full-time role supports the day-to-day operations of clinical trials, with a strong focus on Investigational Product (IP) management while maintaining study integrity between blinded and unblinded staff. The Unblinded CRC serves as the subject-matter expert for IP handling and works closely with the Site Manager, study team, sponsors, and participants to ensure compliance with protocols and SOPs. Key Responsibilities: Managing all aspects of Investigational Product (receipt, storage, dispensing, administration, accountability, and return/destruction) Maintaining the study blind and communicating appropriately with blinded and unblinded team members Conducting patient-facing visits, including vitals, ECGs, lab collection, and protocol-required procedures Completing accurate source documentation and EDC entry within required timelines Monitoring study activities for regulatory and protocol compliance Recording and reporting adverse events and resolving sponsor queries Participating in site audits, monitor visits, investigator meetings, and site initiation visits Maintaining temperature logs, pharmacy binders, and master study logs This position reports directly to the Site Manager/Director and plays a critical role in ensuring studies run smoothly and compliantly. Required Qualifications: Recent, heavy hands-on injection or vaccine administration experience, including independent injection administration in accordance with medication protocols Patient-facing clinical experience (Medical Assistant, Clinical Research Assistant, Research Assistant, LPN, etc.) Ability to work directly with study participants in a clinical setting Strong attention to detail and accurate documentation skills Ability to complete source documentation during patient visits and enter data into EDC within required timelines Ability to follow study protocols, SOPs, and regulatory requirements Basic understanding of GCP and FDA regulations (training acceptable) Strong communication and organizational skills Ability to work Monday-Friday, 8:00 AM-5:00 PM Ability to start ASAP Preferred Qualifications: Previous experience as a Clinical Research Coordinator (CRC) Unblinded CRC or Investigational Product (IP) management experience Experience with drug accountability, temperature logs, and pharmacy binders Experience with Investigational Product preparation and administration Experience participating in monitor visits, audits, SIVs, and investigator meetings Experience using EDC systems and resolving sponsor queries Work Environment: On-site clinical research site supporting active clinical trials and patient-facing activities.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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

PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Senior Oncology Clinical Research Coordinator plans, directs, or coordinates clinical oncology research projects, directs the activities of workers engaged in clinical oncology research projects to ensure compliance with protocols and overall clinical objectives, evaluates and analyzes clinical data. Learn more about the Stephenson Cancer Center's Clinical Trials Office here. Duties: * Identifies, recruits, and schedules patients who may be eligible to participate in the oncology clinical research program. * Performs the initial assessment of potential patient participants, including but not limited to taking detailed clinical history, performing physical exam, and completing patient data forms. * Conducts research tests and supervises exercise training sessions. * Provides potential patient participants with study information. Obtains informed consent forms. * Acts as the initial clinical resource and liaison between physicians, nurses, and laboratory personnel. * Responsible for data management and data analysis. Ensures data entry is accurate and completed in a timely manner. Responsible for the initiation, organization, and handling of patient follow‐up. Assesses and analyzes patient monitor data at all follow‐up visits. May oversee the conduct of home‐based patient training programs. * May attend various meetings pertaining to the oncology clinical research program. May present information at the meeting. * Assumes lead role to ensure adherence to protocol. Directs and evaluates the work of research personnel. Trains and schedules workloads of employees. * Performs various duties as needed to successfully fulfill the function of the position. Required Education and Experience: Bachelor's Degree in Health Profession, Physical Science, Biological Science, Registered Nurse, Physician Assistant, AND: * 48 months of clinical practice, nursing, or research program coordination experience. Equivalency/Substitution: Experience or a combination of education & experience can be considered in lieu of a degree. A one-to-one ratio is used to determine the number of years of experience required in place of a degree. Certifications/Licenses: None Skills: * Advanced knowledge of protocol guidelines, principles, and practices. * Must have a high level of organizational skills. * Ability to exercise discretion. * Ability to ask the right questions to determine proper course of action while following established standards. * Ability to learn and function under different situation and circumstances. * Must work independently and as a team member. * Ability to handle stressful situations and solve problems. * Ability to finish projects in a timely manner. Working Conditions: Standard Clinical Environment Why You Belong at the University of Oklahoma: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement: The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Job Description Title: Nurse Practitioner (NP) or Physician Associate (PA) Job Category: Primary Care Position Type: Full-Time Compensation: $175,000 - $250,000 Are you in Primary Care? If so, see how Triad Backs the Pracs We're not only here for the Operations, Admin, and Full support…when it comes to Financing your operation, Triad Backs the Pracs. We are committed to financially backing your dream. We'll take the wheel to get you set up, then you take the keys. Complete Practice Launchpad Timeline Step 1: We will handle everything needed to open your new Triad Complete Healthcare clinic. From staffing and credentialing to furnishing and most importantly, funding. We manage all the essential tasks to get your practice up and running. Step 2: For the first 12 months, we will employ you and manage all aspects of the practice, including: your team, billing and coding, supervising physician, malpractice insurance, EMR, payroll, advertising, financials, and overall business operations. Our goal is to ensure your practice runs smoothly and successfully. Step 3: After 12 months, we will transfer ownership of the practice and its accounts receivable (A/R) to you. By this point, the practice will have been operating successfully, minimizing risk. You'll begin to reap the rewards of your hard work, with profits supporting the business. We will continue to provide ongoing management and support. Step 4: Approximately 36 months from your first day with Triad Complete Healthcare, you will fully own your practice, free of debt and without needing collateral or an upfront investment. Your clinic is now yours to grow, thrive, and lead on your terms. We believe experienced practitioners do their best work when they can put their patients first. This leads to Provider Centric philosophies. Our Philosophies Autonomy We empower you with the autonomy to run your practice the way you envision it. While you focus on delivering exceptional patient care, we're here to support you every step of the way. Your practice is yours to build, but we ensure you have the resources you need to thrive. Burnout Prevention We prioritize your well-being and work-life balance to help you maintain a fulfilling career. While your autonomy allows you to manage your patient load, we set clear boundaries to prevent burnout. You'll never be expected to see more than 20-22 patients per day, giving you the time to provide thoughtful, quality care without compromising your personal time. Support Support is at the heart of everything we do. Every person involved in your practice-your team, our office staff, and our resources-is here to help you succeed. We believe happy, well-supported providers lead to happy, healthier patients. With this in mind, we make sure you have a strong support network to help you focus on what matters most: your patients. Unmatched Support When you make the move to Triad Complete Healthcare your practice is yours to build. But you don't have to do it alone. You have the autonomy to shape your practice in a way that aligns with your commitment to patient care, all while having the necessary resources to foster meaningful relationships and ensure the best outcomes for your patients. Our support begins the moment you start. We provide a fully equipped office in your community, tailored to help you establish a welcoming and efficient environment for your patients. From day one, you'll have access to a practice administration team who will support you with the administrative tasks, allowing you to focus on what you do best - providing high-quality care for your patients. Summary This program is designed to return practice ownership to the hands of the practitioners. We will cover the costs to set up your clinic, providing you with a fully equipped and operational space. With our proven systems designed for efficiency, we'll help manage your operations to ensure your practice's success. Once established, we hand over the keys of ownership to you, empowering you to take control of your future. At Triad Complete Healthcare, we're committed to shifting the profit from the business of healthcare and reinvesting in the providers who make a difference in patient lives. You can focus on providing high-quality care, while we provide ongoing support to help you thrive. Practitioner Roles and Responsibilities Assesses patient health by interviewing patients and performing physical examinations (including obtaining, updating, and studying medical histories Document patient care services by charting in patient and department records Provides quality outpatient services by appointment Provides ongoing health maintenance, health education and disease prevention periodic screening for adults Provides well-women gynecological exams including appropriate screening, history, examinations and education Provides patient education regarding disease processes and good health habits Maintains current knowledge of immunization schedules, routine adult health maintenance recommendations and general clinic protocols Orders and evaluates appropriate laboratory and x-ray studies Completes Continuing Medical Education and maintains licensure in good standing. Maintains current prescriptive authority license, OBNDD and DEA number Maintains a current knowledge of the Nurse Practitioner formulary and prescribes medications within the limits of the formulary Assists in community health screening and disease prevention activities Informs Medical Director of difficult cases, poor outcomes, or of involvement of other agencies in patient case Interacts effectively with patients, families, clinic team members and anyone necessary to satisfy patient care Qualifications Current valid license as a Nurse Practitioner (NP) or Physician Associate (PA) in Oklahoma. Graduate of an accredited Nurse Practitioner program. Excellent clinical and diagnostic skills Effective communication and interpersonal skills Ability to work effectively in a team environment Dedication to providing high-quality patient care Proficiency in electronic medical records (EMR) systems Commitment to continuous learning and professional development Preferred Skills Communication Skills: To communicate with patients and colleagues, excellent listening, speaking and interpersonal skills are needed. Must be able to understand patient needs, clearly communicate instructions, and build and maintain a trusting relationship Problem Solving: Based on clinical interviews, physical examinations and lab test results, practitioner must be able to identify diseases and other health conditions, make diagnoses, and produce treatment plans Critical Thinking: When developing a treatment plan, practitioner must be able to evaluate various options to treat a condition, then identify the most affective path for the best possible outcome Compassion: Must be able to sympathize with sick and worried patients and their families Leadership Skills: Ability to manage other members of the healthcare team such as RNs, LPNs, and other support staff Powered by JazzHR Vbp4LqeR7E

Title: Nurse Practitioner (NP) or Physician Associate (PA) Job Category: Primary Care Position Type: Full-Time Compensation: $175,000 - $250,000 Are you in Primary Care? If so, see how Triad Backs the Pracs We're not only here for the Operations, Admin, and Full support…when it comes to Financing your operation, Triad Backs the Pracs. We are committed to financially backing your dream. We'll take the wheel to get you set up, then you take the keys. Complete Practice Launchpad Timeline Step 1: We will handle everything needed to open your new Triad Complete Healthcare clinic. From staffing and credentialing to furnishing and most importantly, funding. We manage all the essential tasks to get your practice up and running. Step 2: For the first 12 months, we will employ you and manage all aspects of the practice, including: your team, billing and coding, supervising physician, malpractice insurance, EMR, payroll, advertising, financials, and overall business operations. Our goal is to ensure your practice runs smoothly and successfully. Step 3: After 12 months, we will transfer ownership of the practice and its accounts receivable (A/R) to you. By this point, the practice will have been operating successfully, minimizing risk. You'll begin to reap the rewards of your hard work, with profits supporting the business. We will continue to provide ongoing management and support. Step 4: Approximately 36 months from your first day with Triad Complete Healthcare, you will fully own your practice, free of debt and without needing collateral or an upfront investment. Your clinic is now yours to grow, thrive, and lead on your terms. We believe experienced practitioners do their best work when they can put their patients first. This leads to Provider Centric philosophies. Our Philosophies Autonomy We empower you with the autonomy to run your practice the way you envision it. While you focus on delivering exceptional patient care, we're here to support you every step of the way. Your practice is yours to build, but we ensure you have the resources you need to thrive. Burnout Prevention We prioritize your well-being and work-life balance to help you maintain a fulfilling career. While your autonomy allows you to manage your patient load, we set clear boundaries to prevent burnout. You'll never be expected to see more than 20-22 patients per day, giving you the time to provide thoughtful, quality care without compromising your personal time. Support Support is at the heart of everything we do. Every person involved in your practice-your team, our office staff, and our resources-is here to help you succeed. We believe happy, well-supported providers lead to happy, healthier patients. With this in mind, we make sure you have a strong support network to help you focus on what matters most: your patients. Unmatched Support When you make the move to Triad Complete Healthcare your practice is yours to build. But you don't have to do it alone. You have the autonomy to shape your practice in a way that aligns with your commitment to patient care, all while having the necessary resources to foster meaningful relationships and ensure the best outcomes for your patients. Our support begins the moment you start. We provide a fully equipped office in your community, tailored to help you establish a welcoming and efficient environment for your patients. From day one, you'll have access to a practice administration team who will support you with the administrative tasks, allowing you to focus on what you do best - providing high-quality care for your patients. Summary This program is designed to return practice ownership to the hands of the practitioners. We will cover the costs to set up your clinic, providing you with a fully equipped and operational space. With our proven systems designed for efficiency, we'll help manage your operations to ensure your practice's success. Once established, we hand over the keys of ownership to you, empowering you to take control of your future. At Triad Complete Healthcare, we're committed to shifting the profit from the business of healthcare and reinvesting in the providers who make a difference in patient lives. You can focus on providing high-quality care, while we provide ongoing support to help you thrive. Practitioner Roles and Responsibilities Assesses patient health by interviewing patients and performing physical examinations (including obtaining, updating, and studying medical histories Document patient care services by charting in patient and department records Provides quality outpatient services by appointment Provides ongoing health maintenance, health education and disease prevention periodic screening for adults Provides well-women gynecological exams including appropriate screening, history, examinations and education Provides patient education regarding disease processes and good health habits Maintains current knowledge of immunization schedules, routine adult health maintenance recommendations and general clinic protocols Orders and evaluates appropriate laboratory and x-ray studies Completes Continuing Medical Education and maintains licensure in good standing. Maintains current prescriptive authority license, OBNDD and DEA number Maintains a current knowledge of the Nurse Practitioner formulary and prescribes medications within the limits of the formulary Assists in community health screening and disease prevention activities Informs Medical Director of difficult cases, poor outcomes, or of involvement of other agencies in patient case Interacts effectively with patients, families, clinic team members and anyone necessary to satisfy patient care Qualifications Current valid license as a Nurse Practitioner (NP) or Physician Associate (PA) in Oklahoma. Graduate of an accredited Nurse Practitioner program. Excellent clinical and diagnostic skills Effective communication and interpersonal skills Ability to work effectively in a team environment Dedication to providing high-quality patient care Proficiency in electronic medical records (EMR) systems Commitment to continuous learning and professional development Preferred Skills Communication Skills: To communicate with patients and colleagues, excellent listening, speaking and interpersonal skills are needed. Must be able to understand patient needs, clearly communicate instructions, and build and maintain a trusting relationship Problem Solving: Based on clinical interviews, physical examinations and lab test results, practitioner must be able to identify diseases and other health conditions, make diagnoses, and produce treatment plans Critical Thinking: When developing a treatment plan, practitioner must be able to evaluate various options to treat a condition, then identify the most affective path for the best possible outcome Compassion: Must be able to sympathize with sick and worried patients and their families Leadership Skills: Ability to manage other members of the healthcare team such as RNs, LPNs, and other support staff

Overview and Responsibilities The OMRF Rheumatology Center of Excellence in the Arthritis and Clinical Immunology Research Program seeks to understand roles of the immune system in health and disease. As we continue to expand, we invite qualified candidates to apply for a clinician or clinical investigator position. While we are primarily recruiting at the Clinical Assistant or Associate Professor levels, we encourage talented candidates at all career stages to apply, as all applications will be considered. As part of our mission to deliver outstanding, science-driven clinical care in arthritis and systemic autoimmune rheumatic diseases, successful candidates will have the following responsibilities: Provide high-quality clinical care to patients with systemic autoimmune rheumatic diseases, regardless of their ability to pay. Offer patients the opportunity to participate in longitudinal cohorts and/or clinical trials. Collaborate in a multidisciplinary state-of-the art clinic equipped with 6 additional exam rooms, ophthalmology and dental chairs, infusion suite, and musculoskeletal ultrasound, with advanced human imaging suite and human performance laboratory currently under construction. Work within a robust referral system and enjoy access to OMRF s core facilities, including a CAP-CLIA certified clinical immunology laboratory (autoantibody testing), CAP-certified biorepository, sample procurement and processing, human phenotyping, clinical research, flow cytometry, and imaging. Utilize extensive autoimmune disease and control sample collections for research purposes Participate in clinical trial training, if desired. Receive a generous multi-year start-up package with significant ongoing salary and scholarly activity support. Focus on clinical care while collaborating with other basic and clinical scientists interested in asking patient-oriented research questions in the pathogenesis, prediction, prevention, and precision treatment of autoimmune rheumatic diseases. Develop extramural funding for autoimmune-related research in the etiology and pathogenesis of rheumatic diseases. Minimum Qualifications Medical degree (MD, DO, or MD-PhD) in good clinical standing with passion for caring patients with autoimmune diseases. Licensed to practice in the U.S. (and eligible to obtain an Oklahoma license). Additional training in caring for patients with rheumatoid arthritis, systemic lupus erythematosus (SLE), undifferentiated connective tissue disease (UCTD), and/or Sj gren s syndrome. Strong initiative, commitment to lifelong learning, and ability to work effectively in a multi-disciplinary team-oriented environment. Preferred Qualifications Board certification or eligibility in Internal Medicine, Rheumatology, or related field. Completion of CTS (Clinical and Translational Science) or equivalent research training. Experience in conducting clinical trials. Special Instructions When submitting your application, please upload your CV as prompted. Under the "Document Upload" section, select "Cover Letter" from the dropdown menu and upload your cover letter accordingly. The review of applications will begin immediately and continue until the positions are filled. For preliminary and confidential inquiries, please contact Judith James, M.D., Ph.D., through OMRF's talent acquisition team: Jennifer Allenwood, Human Resources Specialist and Joel Solis, Human Resources Associate, at ******************* OMRF Overview Founded in 1946, the Oklahoma Medical Research Foundation (OMRF) is an independent, not-for-profit, biomedical research institute adjacent to the campus of the University of Oklahoma Health Sciences Center (OUHSC). OMRF investigators enjoy close clinical and scientific interactions with OUHSC faculty and participate in OUHSC house staff, clinical and graduate training programs. OMRF investigators have internationally recognized expertise in Autoimmunity, Immunology, Genetics, Genomics, Aging, Cardiovascular Disease, and Cancer. OMRF follows an innovative cross-disciplinary approach to medical research and ranks among the nation s leaders in patents per scientist. OMRF has been voted one of the Top Workplaces since the inception of the award. This achievement has been accomplished thanks to OMRF individuals who share a unified understanding that our excellence can only be fully realized with a collective commitment to our mission, . . . so that more may live longer, healthier lives. Successful candidates will demonstrate commitment to this mission. Additionally, OMRF is an Equal Opportunity Employer. Among our many Research Centers, we have Centers of Excellence and specialized clinics focused on Rheumatic Diseases (including lupus, rheumatoid arthritis, undifferentiated connective tissue disease, ANA+ healthy individuals, and Sjogren s syndrome), as well as Multiple Sclerosis. We follow over 4,000 patients and conduct extensive clinical, translational, and mechanistic research using patient samples from these programs. OMRF holds significant collaborative funding from NIAID, NIGMS, NIAMS, and other agencies. For more information about the Oklahoma Rheumatic Disease Research Core Center and OMRF Patient Studies, please visit the following sites: ORDCC and Patient Studies. OMRF Benefits We offer competitive salaries and comprehensive benefits to full-time employees including medical, dental, and vision insurance, minimum 8% company retirement contribution, vacation and sick leave, and paid holidays. All employees have access to our onsite caf , free onsite fitness center with access to personal trainer, free parking and much more! Relocation assistance available for those located 50 miles outside of Oklahoma City metro. Learn more about our benefits here.

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Required Education and Experience: Bachelor's Degree in Health Profession, Physical Science, Biological Science, Registered Nurse, Physician Assistant, AND: 48 months of clinical practice, nursing, or research program coordination experience. Equivalency/Substitution: Experience or a combination of education & experience can be considered in lieu of a degree. A one-to-one ratio is used to determine the number of years of experience required in place of a degree. Certifications/Licenses: None Skills: Advanced knowledge of protocol guidelines, principles, and practices. Must have a high level of organizational skills. Ability to exercise discretion. Ability to ask the right questions to determine proper course of action while following established standards. Ability to learn and function under different situation and circumstances. Must work independently and as a team member. Ability to handle stressful situations and solve problems. Ability to finish projects in a timely manner. Working Conditions: Standard Clinical Environment Why You Belong at the University of Oklahoma: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement\: The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services. OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Senior Oncology Clinical Research Coordinator plans, directs, or coordinates clinical oncology research projects, directs the activities of workers engaged in clinical oncology research projects to ensure compliance with protocols and overall clinical objectives, evaluates and analyzes clinical data. Learn more about the Stephenson Cancer Center's Clinical Trials Office here. Duties: Identifies, recruits, and schedules patients who may be eligible to participate in the oncology clinical research program. Performs the initial assessment of potential patient participants, including but not limited to taking detailed clinical history, performing physical exam, and completing patient data forms. Conducts research tests and supervises exercise training sessions. Provides potential patient participants with study information. Obtains informed consent forms. Acts as the initial clinical resource and liaison between physicians, nurses, and laboratory personnel. Responsible for data management and data analysis. Ensures data entry is accurate and completed in a timely manner. Responsible for the initiation, organization, and handling of patient follow‐up. Assesses and analyzes patient monitor data at all follow‐up visits. May oversee the conduct of home‐based patient training programs. May attend various meetings pertaining to the oncology clinical research program. May present information at the meeting. Assumes lead role to ensure adherence to protocol. Directs and evaluates the work of research personnel. Trains and schedules workloads of employees. Performs various duties as needed to successfully fulfill the function of the position. Required Attachments Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process. Important: ALL required documents must be attached to your job application or your documents will not be visible to the hiring department!

**Parexel FSP is looking for a CRA/Sr CRA in the MidWest and West region of the United States!** **Oncology Experience required.** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. \#LI-SS1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

*Clinical Trials Manager - Regulatory Affairs - Job Number: 252699 Organization: Stephenson Cancer CenterJob Location: Oklahoma-Oklahoma City-Health Sciences CenterSchedule: Full-time Work Schedule: Monday-Friday 8am-5pmWork Type: OnsiteSalary Range: Targeted salary range from $55,800 to $72,600, based on experience.Benefits Provided: Yes Required Attachments: Resume, Cover Letter --- OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options.At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Clinical Trials Manager - Regulatory Affairs provides senior administrative management to the clinical trials program by overseeing, training and developing the Clinical Trials Office (CTO) Regulatory Team. Provides professional-level support in evaluating business and operational practices to enhance the quality and delivery of services to the University. Supervises the CTO Regulatory team, ensures CTO processes follow regulatory requirements as set forth by governing agencies, develops strategies to raise awareness for regulatory processes, stays abreast of new industry practices, and acts as a liaison with other departments/organizations. Assists with preparation and production of the annual operating budget.Learn more about the Stephenson Cancer Center's Clinical Trials Office here.Duties:Program Management. Provides direct administrative and fiscal management for regulatory affairs of the program(s) and related grants. Manages the day-to-day business operations of the program. Responsible for overseeing, planning, and monitoring of strategic plans. Manages and implements new workflows and processes to help improve collaboration within all CTO teams.Fiscal/Budget. Responsible for fiscal oversight and management to include decisions regarding appropriate rates within University approved salary ranges for new hires, appropriate increases and promotions for existing staff, and approval of purchases for the Regulatory team such as supplies and equipment. Responsible for financial planning of the program(s) and monitoring progress. Develops and manages the Regulatory team's budget. Ensures the fiscal viability of programs and advises college/department leadership on long-range financial planning and development of new initiatives.Assessment. Ensures staff correctly identifies clinical trial types and the initial assessment of appropriate start up activity to verify completeness, that all applicable trial documents are accurately reflected for the trial, and the consent forms for each study are approved, inclusive of federal, state and institutional required language. Responsible for conducting ongoing assessments of outreach and timelines to determine needed services, funds, and staffing.Information Distribution. Ensures clinic staff and other departments are made aware of new regulatory processes, workflows and standards. Networking with other cancer institutions and applicable research partners to learn and share best practices and improve internal processes.Clinical Resource. Builds and maintains community relationships with outside physicians, other health care organizations, and serves as referral resource for non-CTO staff and investigators. Ensures completion of all aspects of study start up, continuing review, and study close-out are complete from a regulatory perspective.Data Management. Manages clinical trials data and performs data analysis. Establishes and maintains reporting metrics and operational functions to leadership to help meet the institutional mission and objectives.Meeting Attendance. Attends and presents clinical trial and regulatory information at various meetings.Personnel Supervision. Supervises assigned staff to include hiring, training, scheduling workloads, evaluating, and terminating employees. Ensures all employees adhere to institutional policies and procedures while ensuring federal regulations are met.As Needed. Performs various duties as needed to successfully fulfill the function of the position. Job Requirements--- Required Education: Bachelor's Degree in health-related field to include Health Administration, Public Health, Nursing, or closely related field. AND:48 months experience in clinical trials research coordination and/or administration, professional level data management and analysis, or other closely related professional level role.Certifications/Licenses: none Working Conditions:Physical: Sitting for long periods of time. Speaking and listening.Environmental: Office Environment.Department Preferences: Master's degree, strong regulatory operations experience, and experience with clinical trials/ research activities.Why You Belong at the University of Oklahoma: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here!Equal Employment Opportunity Statement: The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services. Hiring contingent upon a Background Check?: YesSpecial Indications: None Job Posting: Dec 8, 2025JOB DESCRIPTION HELP Required Attachments Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process. Important: ALL required documents must be attached to your job application or your documents will not be visible to the hiring department!

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills:** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Required Experience:** + 3+ years of direct Monitoring / CRA experience in a CRO or Pharma organization + 2+ years direct Oncology Monitoring / CRA experience in a CRO or Pharma organization + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree required **Other:** + Ability to travel as required. + Valid driving license per country requirements, as applicable \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Research Coordinator - HPRC assists with a research project by conducting scientific experiments. Uses knowledge of scientific procedures to plan, design, conduct and analyze experiments. Duties: * THIS IS NOT A BIOMEDICAL POSITION * Planning, designing, and conducting scientific experiments. * Monitoring experiments and making observations. * Isolating, identifying, and preparing samples for analysis or examination. * Performing routine or standardized laboratory tests. * Collecting and/or analyzing data. * Conducting special research studies. * Fabricating, modifying, and repairing experimental and laboratory products, using a variety of machines and tools. * Preparing reports summarizing results of experiments or conclusions of research projects. * Cleaning, maintaining, and preparing supplies and work areas. * Keeping detailed records of all work-related activities. * May participate in field explorations, such as mineralogical or geophysical expeditions. * May publish research. * May teach one or more classes or seminars. * May requisition or recommend purchase of materials, tools, and equipment. * Performs various duties as needed to successfully fulfill the functions of the position. Required Education and Experience: Bachelor's degree, AND: * 24 months research or laboratory experience. Equivalency/Substitution: Will accept 48 months experience in lieu of the Bachelor's degree for a total of 72 months of related experience. Skills: * Proficient navigating and maintaining databases * Ability to speak, read and write clear, concise English * Strong oral and written communication skills * Proficient in Microsoft Office * Highly organized and able to handle multiple projects and deadlines * Able to produce reports and complete work within deadlines * Must be able to read and interpret policy as well as State and Federal regulations Certifications or Licenses: None Working Conditions: * Physical: * Ability to engage in repetitive motions. * Must be able to crouch, crawl, and reach. * Environmental: * Research or laboratory environment or in the field. Why You Belong at the University of Oklahoma: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement: The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services.

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Research Coordinator - HPRC assists with a research project by conducting scientific experiments. Uses knowledge of scientific procedures to plan, design, conduct and analyze experiments. Duties: THIS IS NOT A BIOMEDICAL POSITION Planning, designing, and conducting scientific experiments. Monitoring experiments and making observations. Isolating, identifying, and preparing samples for analysis or examination. Performing routine or standardized laboratory tests. Collecting and/or analyzing data. Conducting special research studies. Fabricating, modifying, and repairing experimental and laboratory products, using a variety of machines and tools. Preparing reports summarizing results of experiments or conclusions of research projects. Cleaning, maintaining, and preparing supplies and work areas. Keeping detailed records of all work-related activities. May participate in field explorations, such as mineralogical or geophysical expeditions. May publish research. May teach one or more classes or seminars. May requisition or recommend purchase of materials, tools, and equipment. Performs various duties as needed to successfully fulfill the functions of the position. Required Education and Experience: Bachelor's degree, AND: 24 months research or laboratory experience. Equivalency/Substitution: Will accept 48 months experience in lieu of the Bachelor's degree for a total of 72 months of related experience. Skills: Proficient navigating and maintaining databases Ability to speak, read and write clear, concise English Strong oral and written communication skills Proficient in Microsoft Office Highly organized and able to handle multiple projects and deadlines Able to produce reports and complete work within deadlines Must be able to read and interpret policy as well as State and Federal regulations Certifications or Licenses: None Working Conditions: Physical: Ability to engage in repetitive motions. Must be able to crouch, crawl, and reach. Environmental: Research or laboratory environment or in the field. Why You Belong at the University of Oklahoma\: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here! Equal Employment Opportunity Statement\: The University, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes but is not limited to admissions, employment, housing, financial aid, and educational services. Required Attachments Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process. Important: ALL required documents must be attached to your job application or your documents will not be visible to the hiring department!

**CRA and Sr CRA positions** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.