Clinical research associate jobs in District of Columbia

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 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 DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Join one of the most influential, most quoted and most trusted think tanks! The Brookings Institution is a nonprofit public policy organization based in Washington, DC. Our mission is to conduct in-depth research that leads to new ideas for solving problems facing society at the local, national and global level. We bring together leading experts in government and academia from all over the world, rooted in open-minded inquiry and representing diverse points of view, who provide the highest quality research, policy recommendations, and analysis. Research topics cover a full range of public policy issues in economics, foreign policy, development, governance and metropolitan policy. With fair and transparent business practices, clear communication, mutual respect, and a collaborative atmosphere that offers both professional and personal development opportunities, Brookings offers an inclusive and welcoming workplace that values the efforts of all contributors. The Office of Development manages fundraising across the institution. Focused on a constituency based fundraising model, our team works directly with the research programs and executive office to set an overarching fundraising strategy that supports the important work of our scholars. In Brookings Development, we aim to: * Build and nurture relationships with donors and prospects to raise critical financial resources in support of the institution's fiscal health and to advance the mission of Brookings. * Safeguard Brookings's institutional values of Quality, Independence, and Impact. * Amplify the impact of our scholars' research and steward our donors' generosity with compelling and innovative programming for our donor groups. * Support our Board of Trustees in carrying out its fiduciary responsibilities to protect and sustain the institution. * Partner closely with our colleagues across Brookings by providing best in class fundraising and fundraising operations to benefit all research programs. * In everything we do, strive for excellence, act with integrity, communicate with honesty, show respect and collegiality, be proactive, collaborative, creative, and solutions oriented. Position Location: This position is hybrid. Hybrid positions combine regular in-person presence at our Washington, DC office with the option of at least two days of remote work each week. Responsibilities Ready to contribute to Brookings Success? The Senior Coordinator, Individual Giving provides essential operational, administrative, and writing support to the Individual Giving team. Reporting to the Managing Director of Individual Giving, this role is responsible for managing key systems and processes that support donor engagement, including database maintenance, board briefing development, project coordination, and logistical execution of cultivation, solicitation, and stewardship activities. The Senior Coordinator will prepare board briefings and fundraising materials, ensuring accuracy and timeliness, and serve as the key manager for Raiser's Edge NXT database entry for gift officers across the team. This position resolvealso work with scholars across five programs to develop compelling program and project summaries to advance fundraising goals. Must be able to synthesize feedback from internal stakeholders and revise content to align with project priorities. Success in this role requires strong project management, attention to detail, proactive problem-solving, excellent writing skills, and the ability to anticipate and respond to team needs in a fast-paced environment. Must be able to manage multiple projects at a time with varying priorities. Fundraising and stewardship administrative support (60%) * Partner across the Individual Giving team to track cultivation, solicitation, and stewardship strategies in Raiser Edge NXT for all individual donor activities. * Maintain the database with up-to-date solicitation and cultivation information. * Ensure that all NXT records are up to date with recent meeting activity, meeting read-outs, and immediate next steps. * Lead the proposal review process for the Individual Giving team. * Prepare draft gift agreements for donors. * Help develop giving reports to be shared with the Development Team and Executive Office. * Provide logistical and technical support for meetings and conference calls, send calendar appointments, track anticipated attendance, and prepare attendance reports as needed. * Develop meeting agendas for standing Individual Giving team meetings and circulate meeting notes as appropriate. * Ensure agendas and materials are timely distributed in advance of each meeting. * Conduct mail merges, material compilation, and various other office support projects as needed. * Respond to development specific to questions from donors. * Take meeting notes and ensure follow-up for donor meetings as necessary. * Handle sensitive information and confidential projects. * Through general reading and research, keep up to date with Brookings' research programs and donor interests. * Assist with Board of Trustee business meetings as needed. * Assists with special projects and other duties as needed. Development writing and project coordination (40%) * Serve as project manager for Individual Giving team * Support briefing process for Executive Team meetings with the Board of Trustees and other priority prospects as needed. * Draft compelling proposals and program and project summaries that inspire support for priority work. * Conduct ad-hoc research assignments regarding individual donors. * Format and prepare reports for management and Board review. * Ensures notification of donors about Brookings events and activities. * Research, write and edit proposals and other written fundraising materials as necessary. * Serve as Individual Giving team lead on assigned communication initiatives, in partnership with the Development Communications team. * Coordinate with scholars and other operations staff across programs. Qualifications Ready to make an impact? In this role, you will support Brookings values of collegiality, respect, inclusion, diversity and community, and bring the following qualifications: Education/Experience Requirements Bachelor's degree required. Minimum five years of professional relevant administrative experience required (preferably in a Development Office and/or nonprofit organization). Experience working with high-net worth or high-profile individuals is highly preferred. Must be authorized to work for any employer in the U.S. Knowledge/Skill Requirements Excellent interpersonal, organizational, technical, and communication skills required. Excellent grammar, spelling, proofreading, writing, and editing skills, and ability to research information and compile for briefings. Must have acute attention to detail, and be discreet, dependable, and work quickly. Must have the proven ability to exercise excellent judgment and initiative while maintaining confidentiality. Professional demeanor and high level of comfort working with high-profile individuals. Ability to interact politely with the public, as well as internal constituents, and have an excellent phone and email skills. Must be able to function independently and in close cooperation with others. Must be able to coordinate a variety of tasks simultaneously and consistently follow up on details. Knowledge of Microsoft Office suite, especially Excel, donor software such as Raisers Edge (or other CRM), and the capacity to learn other types of software including Publisher, and Adobe Pro. Additional Information What can we offer you? Brookings provides a generous benefit package that is comprehensive and includes both traditional benefits and unique offerings. Our comprehensive benefits package includes medical, dental, and vision benefits, generous time off, and workplace flexibility. For more information, please visit Brookings Benefits. Brookings requires that all applicants submit a cover letter and resume. Please attach your cover letter and resume as one document when you apply. Please note: if you have applied to more than one Brookings job opening you should add a position-specific cover letter as a separate attachment. Successful completion of a background investigation is required for employment at Brookings. Brookings welcomes and celebrates diversity in all its forms, including diversity of experience, thought, and personal background. We welcome applications that reflect a variety of backgrounds based on ideology, race, ethnicity, religion, national origin, gender, sexual orientation, gender identity or expression, disability, veteran status, first generation college goers, and other factors protected by law. Brookings is proud to be an equal-opportunity employer that is committed to promoting a diverse and inclusive workplace. All selection decisions are based upon merit, skills, abilities and experience.

Why Join CINQCARE? CINQCARE is a provider-led, community-based health and care partner dedicated to improving the health and well-being of those who need care the most, with a deep commitment to high-needs, urban and rural communities. Our local physicians, nurses, and caregivers work together to serve people and the communities they live in, beyond just treating symptoms. We remove barriers by delivering personalized care as close to home as possible, often in-home, because we know a deep understanding of our patient's race, culture, and environment is critical to delivering improved health outcomes. By empowering patients, providers, and caregivers with the support they need, we strive to make health and care a reality-not a burden-every single day. Join us in creating a better way to care. Position Overview The Senior Clinical Project Manager reports to the VP Implementation & Clinical Initiatives with accountability for providing strategy, judgment, organization, and evidenced-based analysis to influence decisions and directly to meet CINQCARE requirements. This role will play a crucial role in supporting the planning, execution, and monitoring of clinical projects. Ensure that project documentation is meticulously maintained, timelines are organized, and the right clinical stakeholders are involved to support project success. The Senior Clinical Project Manager is expected to embody CINQCARE's core values, including, Trusted, Empathetic, Committed, Humble, Creative and Community-Minded. At CINQCARE, we don't have patients or customers - we have Family Members. Key Responsibilities Create detailed project plans to define the scope and deliverables for implementations. Lead the planning, execution, and monitoring of clinical projects to ensure they are completed on time and within budget. This includes developing project plans end-to-end, tracking progress to completion, and coordinating full project execution. Oversee and organize project documentation, ensuring timelines are clearly defined and compliance standards and regulations are adhered to. Ensure the involvement of the appropriate stakeholders to support project objectives. This involves creating and updating project files, managing documents, and ensuring all records are accurate and up to date while reporting out to the executive leadership team. Lead and motivate cross-functional teams and allocate appropriate resources where needed. Communicate to clients and stakeholders to manage expectations, changes, scheduling, and budget. Identify and mitigate potential risks to project timelines and deliverables. Fully develop mitigation strategies to address these risks to manage change efficiently. Develop and partner with finance to control, manage, and forecast associated with projects. Lead project closure, transfer deliverables, and drive process improvements to integrate new tools for future project execution. Required Qualifications Education: An associate's degree or equivalent job experience (7 years of project management type work). Experience: At least 3 years of clinical operations experience and ideal candidates will have 3+ years of relevant project management experience in the healthcare industry. Entrepreneurial: CINQ seeks to fix gaps that have persisted for generations in the delivery of care to Black and Brown populations. This position is accountable for ensuring CINQ is positioned to innovatively deliver on its promise. Communication: Excellent verbal, written communication, and presentation skills with the ability to clearly articulate, present concepts, and models in an accessible manner to CINQ's team, investors, partners, and other stakeholders. Proficiency in all Microsoft Office applications. Relationships: Ability to build and effectively manage relationships with business leaders and external constituents. Culture: Good judgement, impeccable ethics, and a strong team player with desire to succeed and grow in a fast-paced, demanding, and entrepreneurial environment. Our Benefits At CINQCARE, we care for our team like we care for our patients-holistically. We offer flexible, comprehensive benefits so you can thrive while delivering top-notch care. Medical Plans: Two comprehensive options offered to Team members. 401K: 4% employer match for your future. Dental & Vision: Flexible plans with in-network savings. Paid Time Off: Generous PTO, holidays, and wellness time. Extras: Pet insurance, commuter benefits, mileage reimbursement, CME for providers, and company-provided phones for field staff. The working environment and physical requirements of the job include: In-office work is performed indoors in a traditional office setting with conditioned air, artificial light, and an open workspace. In this position you will need an to communicate with customers, vendors, management, and other co-workers in person and over devices, sometimes with people who are agitated. Regular use of the telephone and e-mail for communication is essential. Sitting for extended periods is common. Must be able to receive ordinary information and to prepare or inspect documents. Lifting of up to 10 lbs. occasionally may be required. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and FAX machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business. Equal Opportunity & Reasonable Accommodation Statement CINQCARE is an Equal Opportunity Employer committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic under applicable law. If you require a reasonable accommodation during the application or employment process, please indicate this in your application or speak with your recruiter during the hiring process. Disclaimer This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Management reserves the right to modify, add, or remove duties as necessary.

Vanda, a specialty pharmaceutical company based in Washington, D.C., focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients, is looking for a talented and patient focused M.D. / Ph.D to join our growing Research & Development team. Responsibilities: Responsible for developing and implementing clinical program strategies for phase I-IV studies. Participates in preparing regulatory filings (i.e. annual updates, NDAs, INDs, etc.) Manages preparation of scientific presentations and publications. Position Requirements: M.D. or PhD required Excellent written and oral communication skills Scientific publication record Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship. The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at ************ between 8:00 AM and 5:30 PM ET, Monday through Friday.

**Become a part of our caring community and help us put health first** The Senior Clinical Operations Training Professional provides training support (both virtual and onsite) and implements organizational processes and programs to ensure new hires to the organization, along with, the staff and facilities in emerging markets are fully prepared for successful operations. This role includes an opportunity to travel to new and existing clinics across the US and participate in go-live support. The Senior Clinical Operations Training Professional collaborates with training colleagues, market leadership, clinical and non-clinical associates throughout the organization. Secures needed resources and establishes/verifies key performance indicators to ensure readiness. Leads the transition to ongoing operational processes. Understands department, segment, and organizational strategy and operating objectives, including their linkages to related areas to connect the dots within the market. Follows established guidelines/procedures. Makes decisions on moderately complex to complex issues regarding technical approach for project components and work is performed with minimal direction. Has advanced level knowledge and a deep understanding of clinical workflows. Will conduct in-person, classroom, one on one and virtual learning sessions for care team members. **Use your skills to make an impact** **Required Qualifications** + Clinical and operational experience in a healthcare facility. + Five or more years training experience in a clinical setting to include electronic medical record implementation + Experience providing training and support virtually + Strong written and verbal communication skills + Strong customer service skills + Prior experience with delivering presentations to all levels of leadership. + Demonstrated ability to translate analytics into action and use the data to impact and influence business outcomes. + Microsoft Office proficiency - able to write queries, create forms, reports, presentations, and documents in Word, Power Point, Access and Excel **Preferred Qualifications** + Bachelor's Degree + eCW and/or Athena EMR experience + Understanding of Value Based Care model **Additional Information** + Travel required up to 75% of the time. Work from home when not traveling. + Strong preference incumbent live near a PCO market in the following states: GA, TX, NC, SC, IN, KY, FL, AZ, MS, LA, TN, KS, VA, MO Travel: While this is a remote position, occasional travel to Humana's offices for training or meetings may be required. **Scheduled Weekly Hours** 40 **Pay Range** The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc. $78,400 - $107,800 per year This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance. **Description of Benefits** Humana, Inc. and its affiliated subsidiaries (collectively, "Humana") offers competitive benefits that support whole-person well-being. Associate benefits are designed to encourage personal wellness and smart healthcare decisions for you and your family while also knowing your life extends outside of work. Among our benefits, Humana provides medical, dental and vision benefits, 401(k) retirement savings plan, time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave), short-term and long-term disability, life insurance and many other opportunities. Application Deadline: 11-29-2025 **About us** About CenterWell Senior Primary Care: CenterWell Senior Primary Care provides proactive, preventive care to seniors, including wellness visits, physical exams, chronic condition management, screenings, minor injury treatment and more. Our unique care model focuses on personalized experiences, taking time to listen, learn and address the factors that impact patient well-being. Our integrated care teams, which include physicians, nurses, behavioral health specialists and more, spend up to 50 percent more time with patients, providing compassionate, personalized care that brings better health outcomes. We go beyond physical health by also addressing other factors that can impact a patient's well-being. About CenterWell, a Humana company: CenterWell creates experiences that put patients at the center. As the nation's largest provider of senior-focused primary care, one of the largest providers of home health services, and fourth largest pharmacy benefit manager, CenterWell is focused on whole-person health by addressing the physical, emotional and social wellness of our patients. As part of Humana Inc. (NYSE: HUM), CenterWell offers stability, industry-leading benefits, and opportunities to grow yourself and your career. We proudly employ more than 30,000 clinicians who are committed to putting health first - for our teammates, patients, communities and company. By providing flexible scheduling options, clinical certifications, leadership development programs and career coaching, we allow employees to invest in their personal and professional well-being, all from day one. **Equal Opportunity Employer** It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to advance in employment individuals with disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment. Centerwell, a wholly owned subsidiary of Humana, complies with all applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, sex, sexual orientation, gender identity or religion. We also provide free language interpreter services. See our full accessibility rights information and language options *************************************************************

Job DescriptionClinical Research Director - Washington DC Trusted Medical (************************ is a value-driven organization dedicated to delivering direct, high-quality healthcare services across 22 states. Our national network of clinics supports active military personnel, Veterans, and the broader community through comprehensive care to our patient population. Trusted Medical is driving to expand our research capabilities while maintaining a strong scientific foundation, keen strategic oversight skills, participation in developing and implementing new clinical trials to grow our research operations. We are seeking a full-time Clinical Research Director (CRD) to join our national clinical trials team in Washington, DC. The CRD will lead the Trusted Medical Research Institue activities including multiple clinical studies, playing a pivotal role in coordinating daily operations and ensuring compliance with regulatory requirements and protocol standards. The CRD will apply their experience to program refinement and improvements for all those accessing and associated with our clinical trials including registrants, participants, vendors, and key stakeholders. In addition, they will support our program in leading clinical trials with an innovative approach, creating massive opportunity of inclusivity and expanding clinic trial accessibility to all. The ideal candidate must demonstrate strong organizational skills, attention to detail, and a compassionate approach to participant engagement. Type of Employment: Full-time, W2 Work Location/Travel: Onsite in Washington, DC. Occasional travel is required to support national study meetings or site activities. Salary Range:$95,000-$105,000. Potential for annual bonus is based on individual performance and meeting or exceeding design organizational metrics. Role Reports to: Nurse Executive Direct Reports: This is a leadership role with direct supervisory responsibilities including interviewing, hiring, training, and monitoring performance for all Trusted Medical Research staff (Clinical Research Coordinators). Supervision will occur virtually and will require periodic travel to clinics to meet with the research staff. Responsibilities: Oversee Clinical Trials: Develop, implement, and manage all aspects of clinical research studies from initiation to completion, ensuring they meet required compliance and ethical standards Strategic Leadership: Provide scientific and strategic direction for the clinical research program, collaborating with cross-functional teams . Staff Management: Lead and mentor research personnel, ensuring effective recruitment, training, and performance management within the team . Regulatory Compliance: Ensure that all clinical trials adhere to regulatory bodies such as the FDA and comply with Good Clinical Practice (GCP) guidelines . Budget Management: Manage clinical trial budgets, resource allocation, and financial reporting to ensure projects are completed on time and within budget . Data Oversight: Monitor data collection, analysis, and reporting to ensure accuracy and scientific rigor in all research activities . Stakeholder Communication: Act as the main point of communication for stakeholders, presenting findings and updates on research progress to internal and external parties Knowledge and Skills Required: Working knowledge of FDA, ICH-GCP, and OHRP regulations Expert understanding of clinical research protocols and informed consent procedures Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems Excellent written and verbal communication skills High attention to detail and strong follow-through skills Ability to work independently and collaboratively across leadership and clinical teams Education/Certification Required: Educational Background: Typically requires at leas Master's degree or Ph.D. in a relevant scientific field (e.g., clinical research, pharmacology) Clinical Research Coordinator certification (ACRP-CRC or SOCRA-CCRC) preferred Experience Required: Proven success of supporting 5+ years in clinical research and prior managerial experience; extensive knowledge of clinical trial processes and regulations is essential. Experience working on multi-site or national studies Expertise in regulatory submissions and IRB processes Experience working with NIH, CMS, or FDA-sponsored studies is highly desired Technical Skills Required: Proficiency in Microsoft Products: Word, Excel, PowerPoint Experience with electronic regulatory and EDC platforms Proficiency in research database tools (e.g., REDCap, Medidata Rave) Benefits: 401(k) with employer matching Health, Dental, and Vison insurances Flexible schedule Life, long and short-term disability insurances 5 days Sick/Safe Leave Paid time off and 2 additional float holidays 6 paid Federal Holidays All applicants must be US citizens and able to obtain a Public Trust clearance. Trusted Medical participates in the E-Verify program and is a drug-free workplace. Trusted Medical is an Equal Opportunity and Affirmative Action Employer. We prohibit discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law. We take affirmative action to employ and advance in employment individuals without regard to protected status.

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Clinical Research Medical Sr. Director - Thoracic Oncology** **What you will do** Let's do this. Let's change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include: + Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team. + Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies. + Integral contribution to SCLC product team + Manage a clinical development team of clinical research medical directors and medical science directors + Provide medical leadership for clinical trials and develop and implement strategies to drive patient enrollment in partnership with clinical operations and medical affairs organizations. + Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s) + Participate and provide clinical input into safety and regulatory interactions. + Interpret and communicate clinical trial data. + Lead authoring and review of CSRs, publications and regulatory submissions + Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings + Identify new clinical research opportunities. + Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Approximate 10% travel may be required. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. **Basic Qualifications:** MD or DO degree from an accredited medical school AND 5 years of clinical research and/or basic science research experience AND 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources **Preferred Qualifications:** + MD plus accredited residency and fellowship training in oncology, board certified or equivalent. Five (5) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities. + Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) + Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization. + Involved in filing activities as part of the moving the program through the development lifecycle. + Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders. + Previous management experience of clinical development professionals **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Clinical Research Coordinator - Washington DCClinical Research CoordinatorTrusted Medical (************************ is a value-driven organization dedicated to delivering direct, high-quality healthcare services across 22 states. Our expanding network of clinics and research operations supports active military personnel, Veterans, and the broader community through comprehensive care and cutting-edge clinical trials. We are seeking a full-time Clinical Research Coordinator (CRC) to join our national clinical trials team. The CRC will support multiple clinical studies, playing a pivotal role in coordinating daily operations and ensuring compliance with regulatory requirements and protocol standards. The CRC will apply their experience to program refinement and improvements for all those accessing and associated with our clinical trials including registrants, participants, vendors, and key stakeholders.In addition, they will support our program in leading clinical trials with an innovative approach, creating massive opportunity of inclusivity and expanding clinic trial accessibility to all. The ideal candidate will demonstrate strong organizational skills, attention to detail, and a compassionate approach to participant engagement.Type of Employment: Full-time, W2Work Location/Travel: Regional based approach, employee will need to report to an established Trusted Medical clinic. Occasional travel is required to support national study meetings or site activities. Salary Range: $60,000-$80,000. Base pay. Competitive salary/pay, potential for bonus based on key performance indicators. There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is highly competitive and dependent upon employment type. Role Reports to: Nurse Executive Direct Reports: This role has no direct reports, however, will be working in collaboration with Trusted Medical clinic and call center staff daily. Responsibilities:• Coordinate daily operations for assigned clinical trials from initiation to closeout • Recruit, screen, and enroll study participants according to protocol eligibility criteria Clinical Research Coordinator - Washington DC • Obtain and document informed consent in compliance with ICH-GCP and IRB requirements • Maintain accurate and complete source documentation, case report forms (CRFs), and logs • Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and sponsors • Schedule and conduct study visits, procedures, and follow-up appointments • Administer study questionnaires, assessments, and ePROs (electronic patient-reported outcomes) • Ensure protocol adherence and proactively identify deviations or violations • Manage and track investigational product (IP) inventory, storage, dispensing, and return • Monitor participant safety and report adverse events (AEs) and serious adverse events (SAEs) • Serve as primary contact for study monitors, sponsors, auditors, and regulatory agencies • Facilitate and participate in site selection, initiation, monitoring, and closeout visits • Enter and verify data in electronic data capture (EDC) systems • Reconcile study data queries and ensure timely resolution of discrepancies • Maintain study files, regulatory binders, and essential documentation per FDA 21 CFR Part 11 • Coordinate specimen collection, processing, and shipping to central labs or biorepositories • Support budget development, invoicing, and payment tracking for study-related procedures • Train and oversee study support staff, interns, or volunteers (if applicable) • Prepare for and participate in audits, monitoring visits, and quality assurance reviews • Maintain credentialing, licenses, and required study training documentation • Ensure compliance with HIPAA and data privacy regulations during research activities • Track enrollment targets, retention, and study milestones to ensure timely progress • Support development and updates of standard operating procedures (SOPs) • Communicate study updates to investigators, sponsors, and internal stakeholders • Collaborate with pharmacy, radiology, lab, and clinical teams for protocol-specific coordination • Participate in feasibility assessments for new research opportunities • Assist in drafting study materials, recruitment tools, and IRB communication. • Provide participants with study education, visit reminders, and engagement support • Manage scheduling software, calendars, and workflow tools to maintain operational efficiency • Attend sponsor, CRO, or consortium training meetings onsite, or virtual as required Clinical Research Coordinator - Washington DC Knowledge and Skills Required: - Working knowledge of FDA, ICH-GCP, and OHRP regulations - Expert understanding of clinical research protocols and informed consent procedures - Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems - Excellent written and verbal communication skills - Attention to detail with ability to track items to resolution - Ability to work independently and collaboratively across teams Education/Certification Required:- Bachelor's degree in life sciences, healthcare, or a related field - Clinical Research Coordinator certification (ACRP-CRC or SOCRA-CCRC) preferred Experience Required:- Proven success of supporting 5 or more years of experience in CLINICAL research - Experience working on multi-site or national studies - Expertise in regulatory submissions and IRB processes - Experience working with NIH, CMS, or FDA-sponsored studies is highly desired Technical Skills Required: - Proficiency in creating and presenting materials with Microsoft Products: Word, Excel, PowerPoint -Experience with electronic regulatory and EDC platforms - Proficiency in research database tools (e.g., REDCap, Medidata Rave) All applicants must be US citizens and able to obtain a Public Trust clearance. Trusted Medical participates in the E-Verify program and is a drug-free workplace. Trusted Medical is an Equal Opportunity and Affirmative Action Employer. We prohibit discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law. We take affirmative action to employ and advance in employment individuals without regard to protected status..

Clinical Research Assistant - (250002RZ) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) Minimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documenting participant incentive distribution. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Completes accurate IRB submissions within institutional timeframes. Records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 8:30a-5pJob Posting: Nov 10, 2025, 4:06:21 PMFull-Time Salary Range: 42702. 4 - 71156. 8

About the Humane Rescue Alliance (HRA) For more than 150 years, the Humane Rescue Alliance has championed the protection of animals, support for people, and service to the community. With campuses in the District of Columbia and New Jersey, along with the nation's leading pet transport initiative, it stands as the largest and most comprehensive animal services provider in the region. Each year, HRA transforms the lives of tens of thousands of animals through rescue and adoption, humane protection, access to medical care, innovative community programs, and legislative leadership. Its broad reach and deep expertise enables HRA to reimagine traditional sheltering and address the most complex challenges facing animals and the people who love them. Job Summary The Humane Rescue Alliance (HRA) seeks a dedicated Clinical Operations Coordinator to join our dynamic medical team. This role combines hands-on veterinary technical work with critical administrative and operational support to ensure animals in our care and those we serve in the community receive high-quality, compassionate medical services. This role will rotate between medical, surgical, and administrative functions primarily at our community clinic in southeast Washington D.C. The successful candidate will provide direct animal care and surgical support, while also managing practice management software, inventory, and supporting the Director of Medical Programs in expanding services and implementing new programs. This role is ideal for someone with strong veterinary technical skills who also excels in organization, communication, and client service in a fast-paced environment. The Role: What You'll Do Clinical & Technical Support Assist veterinarians during patient appointments, obtain patient histories, perform diagnostics, administer treatments, and review discharge instructions. Provide surgical support including preparation, induction, intubation, anesthesia monitoring, recovery, and emergency intervention. Collect, prepare, and analyze laboratory samples; calculate, administer, and record medications; maintain controlled drug logs and fill prescriptions. Perform and assist with humane euthanasia when necessary. Train new and existing staff in daily operations, technical skills, and safety protocols. Maintain medical and laboratory equipment. Administrative & Operational Coordination Coordinate scheduling of medical appointments and surgery. Utilize practice management software to maintain accurate and complete medical records. Manage clinic inventory. Provide excellent customer service by responding to inquiries, explaining procedures, and providing client education. Address and escalate safety concerns or client service issues promptly and appropriately. Provide support to the Director of Medical Programs in the development and implementation of new community initiatives. Other duties as assigned. About You: Skills & Qualifications Five or more years of experience as a veterinary technician in an animal hospital or shelter, demonstrating strong organizational skills required. Certified or Licensed Veterinary Technicians are encouraged to apply. One or more years of customer service, administrative, or clinic operations experience in a fast-paced environment, with proven ability to train others, prioritize tasks, and maintain efficient workflows. Proficient technical skills including administering medications, phlebotomy, IV catheter placement, anesthesia monitoring, and lab diagnostics. Knowledge of restraint and animal handling techniques, animal safety practices, and recognition of behavior patterns. Proficient in Microsoft 365, shelter andpractice management software, and internet applications. Strong interpersonal skills with a customer-service orientation; able to communicate in a professional, empathetic manner with staff, clients, and volunteers. Ability to work evenings, weekends, and holidays as scheduled. Successful completion of HRA Euthanasia Certification program within 6 months of hire. Previous Fear Free Certification or successful completion of Fear Free Shelter certification within 6 months of hire. Ability to work independently and collaboratively in high-stress, fast-paced environments with multiple priorities. Passion for HRA's mission and commitment to caring for all animals regardless of species, age, or temperament. Qualifications - Education & Experience Five or more years of experience as a veterinary technician . One or more years of customer service or administrative experience preferred. Certified/Licensed Veterinary Technician are encouraged to apply. Where You'll Work: Physical Requirements & Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the primary functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Availability and ability to work occasional weekend or weeknight hours. Annual travel to Madison for major gifts support. Regularly sits at a computer station and operates electronic equipment. Ability to be comfortable working with cats, dogs, small animals, reptiles, fish and wildlife. Due to nature of shelter work, may be exposed to deceased, fractious, or aggressive animals; hostile or irate persons; zoonotic or other diseases; unpleasant noises, odors, or sights; and extreme temperatures. Ready to Make an Impact? Apply today and become part of a team where your compassion, skills, and commitment will directly save lives and strengthen communities. The Humane Rescue Alliance (HRA) offers a comprehensive benefits package including healthcare, vision, dental and select offerings for pets. Additional information may be provided upon request. Multilingual candidates are encouraged to apply. A salary premium may be offered for multilingual candidates who demonstrate proficiency in written and oral testing. HRA is committed to being an Equal Opportunity Employer, and does not discriminate because of race, color, creed, gender, religion, national origin, disability, age, pregnancy, genetic predisposition or carrier status, marital status, citizenship status, or sexual orientation. Accommodation will be provided to qualified individuals requiring them.

Clinical Research Assistant - (250002RZ) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) Minimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documenting participant incentive distribution. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Completes accurate IRB submissions within institutional timeframes. Records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 8:30a-5pJob Posting: Nov 10, 2025, 4:06:21 PMFull-Time Salary Range: 42702. 4 - 71156. 8

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Requirements Job Overview The Clinical Research Coordinator (CRC) will be responsible for managing a portfolio of clinical trials overseen by the Clinical Research Organization (CRO) at Georgetown University Medical Center (GUMC). Working under the direct supervision of the Director of the CRO, the CRC will coordinate and oversee complex clinical trials across multiple studies and therapeutic areas. The CRO supports research efforts for various clinical departments within GUMC, and the CRC plays a critical role in ensuring that all trials are conducted in strict accordance with study protocols, regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines. This individual will also provide direct support to research participants and collaborate closely with internal and external stakeholders to maintain high standards of research integrity and compliance. Duties include but are not limited to: * Coordinate and manage clinical research studies, ensuring compliance with regulatory, institutional, and sponsor requirements * Recruit, consent, and monitor study participants; conduct study visits and collect clinical data * Maintain accurate study documentation, including regulatory submissions, data entry, and reporting of adverse events * Serve as a liaison between investigators, sponsors, IRB, and other research and clinical staff to support study integrity and progress Work Interactions This position reports directly to the Director of the Clinical Research Organization (CRO), who in turn reports to the Vice President for Biomedical Graduate Education and Research. The Clinical Research Coordinator will have direct interaction with research participants, and their families. They will work as part of the multidisciplinary Georgetown-MedStar research team and will serve as the primary point of contact for study sponsors, contract research organizations (CROs), and institutional review boards (IRBs). Requirements and Qualifications * Minimum Bachelor's degree in a scientific or related field * 1-3 years of clinical research experience preferably at an academic medical center * Excellent written and verbal communication skills * Detail oriented with strong documentation skills * Familiarity with human subjects research regulations (IRB, FDA, HIPAA) * Strong organizational, critical thinking, and problem-solving skills * Proficient in Microsoft Office Suite and research database systems * Experience with OnCore (Clinical Trials Management System) * Experience with electronic data capture systems (e.g., REDCap, Medidata, etc.) * Certified clinical research certification (SoCRA or ACRP) preferred Work Mode Designation This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website: *************************************************** Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $20.16 - $31.30 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ or ********************. Need some assistance with the application process? Please call ************. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website. EEO Statement: GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits: Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.

Posting Date 10/02/20256600 France Ave SSte 660, Edina, Minnesota, 55435-1807, United States of America At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work. Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine. Sound like you? Then you might be a great fit for a Clinical Research Coordinator role with DaVita Clinical Research (DCR) We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work. This position will be based in our Edina, MN site and coordinate and execute all aspects of late phase clinical trials in Minneapolis and surrounding areas. Based on business needs, a flexible weekly work schedule may be available. ESSENTIAL DUTIES & RESPONSIBILITIES: Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out. Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities. Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates. Responsible to deliver or exceed project enrollment targets for clinical research studies at their site. Responsible for accurate and timely data entry into the electronic data entry systems. Responsible for timely resolution of all data queries to meet project timelines for database lock. Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law. Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry. Understands and promotes compliance with all applicable healthcare and research regulations. MINIMUM QUALIFICATIONS High School Diploma or equivalent is required. Bachelor's Degree is preferred. Minimum 1 year of clinical research experience managing studies from start up to close out or equivalent experience. Reliable transportation to travel between local research sites. Fluency in Spanish (spoken and written) is preferred. Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions. Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through. Experience in managing confidential information and/or issues using discretion and Judgment Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US. What We'll Provide: More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings. Flexible weekly work schedule: This will vary and is based on current business needs December Industry wellness break (Week between Christmas and New Year's Day) Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: Family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave and more Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning. Here is what you can expect when you join our Village: • A "community first, company second" culture based on Core Values that really matter. • Clinical outcomes consistently ranked above the national average. • Award-winning education and training across multiple career paths to help you reach your potential. • Performance-based rewards based on stellar individual and team contributions. • A comprehensive benefits package designed to enhance your health, your financial well-being and your future. • Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation. Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen." Why wait? Explore a career with DaVita today. Go to ************************* to learn more or apply #LI-JD2 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. The Salary Range for the role is $70,512.00 - $117,769.60 per year. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

Job DescriptionClinical Research Coordinator - Washington DCClinical Research CoordinatorTrusted Medical (************************ is a value-driven organization dedicated to delivering direct, high-quality healthcare services across 22 states. Our expanding network of clinics and research operations supports active military personnel, Veterans, and the broader community through comprehensive care and cutting-edge clinical trials. We are seeking a full-time Clinical Research Coordinator (CRC) to join our national clinical trials team. The CRC will support multiple clinical studies, playing a pivotal role in coordinating daily operations and ensuring compliance with regulatory requirements and protocol standards. The CRC will apply their experience to program refinement and improvements for all those accessing and associated with our clinical trials including registrants, participants, vendors, and key stakeholders.In addition, they will support our program in leading clinical trials with an innovative approach, creating massive opportunity of inclusivity and expanding clinic trial accessibility to all. The ideal candidate will demonstrate strong organizational skills, attention to detail, and a compassionate approach to participant engagement.Type of Employment: Full-time, W2Work Location/Travel: Regional based approach, employee will need to report to an established Trusted Medical clinic. Occasional travel is required to support national study meetings or site activities. Salary Range: $60,000-$80,000. Base pay. Competitive salary/pay, potential for bonus based on key performance indicators. There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is highly competitive and dependent upon employment type. Role Reports to: Nurse Executive Direct Reports: This role has no direct reports, however, will be working in collaboration with Trusted Medical clinic and call center staff daily. Responsibilities:• Coordinate daily operations for assigned clinical trials from initiation to closeout • Recruit, screen, and enroll study participants according to protocol eligibility criteria Clinical Research Coordinator - Washington DC • Obtain and document informed consent in compliance with ICH-GCP and IRB requirements • Maintain accurate and complete source documentation, case report forms (CRFs), and logs • Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and sponsors • Schedule and conduct study visits, procedures, and follow-up appointments • Administer study questionnaires, assessments, and ePROs (electronic patient-reported outcomes) • Ensure protocol adherence and proactively identify deviations or violations • Manage and track investigational product (IP) inventory, storage, dispensing, and return • Monitor participant safety and report adverse events (AEs) and serious adverse events (SAEs) • Serve as primary contact for study monitors, sponsors, auditors, and regulatory agencies • Facilitate and participate in site selection, initiation, monitoring, and closeout visits • Enter and verify data in electronic data capture (EDC) systems • Reconcile study data queries and ensure timely resolution of discrepancies • Maintain study files, regulatory binders, and essential documentation per FDA 21 CFR Part 11 • Coordinate specimen collection, processing, and shipping to central labs or biorepositories • Support budget development, invoicing, and payment tracking for study-related procedures • Train and oversee study support staff, interns, or volunteers (if applicable) • Prepare for and participate in audits, monitoring visits, and quality assurance reviews • Maintain credentialing, licenses, and required study training documentation • Ensure compliance with HIPAA and data privacy regulations during research activities • Track enrollment targets, retention, and study milestones to ensure timely progress • Support development and updates of standard operating procedures (SOPs) • Communicate study updates to investigators, sponsors, and internal stakeholders • Collaborate with pharmacy, radiology, lab, and clinical teams for protocol-specific coordination • Participate in feasibility assessments for new research opportunities • Assist in drafting study materials, recruitment tools, and IRB communication. • Provide participants with study education, visit reminders, and engagement support • Manage scheduling software, calendars, and workflow tools to maintain operational efficiency • Attend sponsor, CRO, or consortium training meetings onsite, or virtual as required Clinical Research Coordinator - Washington DC Knowledge and Skills Required: - Working knowledge of FDA, ICH-GCP, and OHRP regulations - Expert understanding of clinical research protocols and informed consent procedures - Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems - Excellent written and verbal communication skills - Attention to detail with ability to track items to resolution - Ability to work independently and collaboratively across teams Education/Certification Required:- Bachelor's degree in life sciences, healthcare, or a related field - Clinical Research Coordinator certification (ACRP-CRC or SOCRA-CCRC) preferred Experience Required:- Proven success of supporting 5 or more years of experience in CLINICAL research - Experience working on multi-site or national studies - Expertise in regulatory submissions and IRB processes - Experience working with NIH, CMS, or FDA-sponsored studies is highly desired Technical Skills Required: - Proficiency in creating and presenting materials with Microsoft Products: Word, Excel, PowerPoint -Experience with electronic regulatory and EDC platforms - Proficiency in research database tools (e.g., REDCap, Medidata Rave) All applicants must be US citizens and able to obtain a Public Trust clearance. Trusted Medical participates in the E-Verify program and is a drug-free workplace. Trusted Medical is an Equal Opportunity and Affirmative Action Employer. We prohibit discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law. We take affirmative action to employ and advance in employment individuals without regard to protected status..

Job DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as study coordinator to execute trials conducted within physician practices, including but not limited to: Visit preparation activities Visit follow-up activities Supply and inventory management Third party vendor coordination Conduct patient recruitment and enrollment of eligible patients Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. Independently administer the informed consent process with care and quality Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Attend study start-up and planning meetings, including PSVs and SIVs 8. Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Assist in Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role3+ years of experience independently coordinating studies, from study startup to close out3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience 2+ years expert knowledge of FDA regulations and ICH/GCP guidelines We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Minimum Education BA/BS degree in a science, technical, health-related field or another applicable discipline. (Required) Minimum Work Experience 0 years Experience working in a medical or scientific research setting (Preferred) Functional Accountabilities Responsible Conduct of Research * Consistently demonstrates adherence to the standards for the responsible conduct of research. * Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. * Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. * Uses research funds and resources appropriately. * Maintains confidentiality of data as required. * Meets all annual job-related training and compliance requirements. Research Administration * Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. * Accurately creates, completes, maintains and organizes study documents. * Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. * Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. * Attends study meetings, which could include overnight travel, as requested by principal investigator. * Works well with other members of the research team and seeks and provides input when appropriate. Participant Enrollment * Adheres to the IRB-approved recruitment plan. * Identifies participants that meet eligibility requirements under the supervision of a senior research team member. * Screens subjects for eligibility per the protocol and institutional policies. * Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. * Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. * Engages participants/LARs in the informed consent process according to institutional policies. * Follows procedures for documenting participant incentive distribution. Study Management * Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. * Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. * Completes accurate IRB submissions within institutional timeframes. * Records participant visits in the appropriate tracking system. * Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Data Collection * Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). * Ensures that queries are resolved within sponsor and institutional timelines. * Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. * Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements. * Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication * Demonstrate collaborative and respectful behavior * Partner with all team members to achieve goals * Receptive to others' ideas and opinions Performance Improvement/Problem-solving * Contribute to a positive work environment * Demonstrate flexibility and willingness to change * Identify opportunities to improve clinical and administrative processes * Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility * Use resources efficiently * Search for less costly ways of doing things Safety * Speak up when team members appear to exhibit unsafe behavior or performance * Continuously validate and verify information needed for decision making or documentation * Stop in the face of uncertainty and takes time to resolve the situation * Demonstrate accurate, clear and timely verbal and written communication * Actively promote safety for patients, families, visitors and co-workers * Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Clinical Research Coordinator - (250001A7) Description The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. Qualifications Minimum EducationBachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: COE Hospital-Based SpecliatiesPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: M-F,8:30-5pJob Posting: May 6, 2025, 7:14:52 PMFull-Time Salary Range: 50252.8 - 83761.6

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Requirements Job Overview The Clinical Research Coordinator (CRC) for the Clinical Research Unit (CRU) at Georgetown University will support Clinical Research Nurses (CRN) in the care of research and standard of care patients, processing and shipping of laboratory specimens and provide services as a certified DXA technician/coordinator. This role is integral to the team effort that provides comprehensive care for clinical trials supported by the CRU. The incumbent will engage in coordination of quality improvement measures as needed and will provide clinical and laboratory support for off-site visits. These functions are performed in accordance with all applicable laws and regulations and Georgetown University Medical Center's philosophy, policies, procedures, and standards. Additional duties include, but are not limited to: * Assist CRNs with clinical research, standard of care tasks and off-site visits * Take vital signs, perform ECGs, and phlebotomy * Pick up and deliver drugs from Research and Main Pharmacy * Transport subjects * Independent review of medical record for health and bone history * Maintain quality control of DXA unit * Fulfill receptionist duties as needed * Process, store and ship laboratory specimens * Maintain IATA Certification * Perform, analyze and report results for research and standard of care DXA scans Work Interactions The Clinical Research Coordinator will work under the direct supervision of CRNs who will delegate appropriate tasks and report directly to CRU Nurse Manager. They will provide clinical support to the registered nurse for research related clinical care and standard of care activities for subject and patients on the CRU while always following best patient relation practices. They are expected to function autonomously and be the CRU experts in matters of DXA operation, procedures and laboratory skills. They will report to the DXA training coordinator or designee for scan training and sign off until they are certified and deemed competent. Once competent and certified the DXA coordinator and training coordinator will work collaboratively to accomplish goals of DXA services for the CRU. Requirements and Qualifications * Bachelors in Science or equivalent * Prior experience performing clinical assistant, phlebotomy, and clinical research assistant functions * BLS certification required, IV insertion skills, DXA and Bilingual experience a plus. * International Society for Clinical Densitometry certification is expected to be obtained within the first year of employment if does not have at date of hire Work Mode Designation This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website: *************************************************** Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $20.16 - $31.30 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at ************ or ********************. Need some assistance with the application process? Please call ************. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website. EEO Statement: GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law. Benefits: Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.