Clinical research coordinator jobs in Frederick, MD

IMPORTANT NOTICE: Arlington County requires all applicants to thoroughly complete each section of the application, including prior job responsibilities, duties, and supplemental questions. While you may attach a resume, it will not replace a completed application. Incomplete applications will not be considered. The Arlington County Treasurer's Office is seeking a Treasury Specialist II - Compliance and Research Specialist, to assist with the collection of delinquent accounts and participate on the call center team within the Compliance Division of the Arlington County Treasurer's Office. The employee will perform a variety of front-line customer service, compliance, administrative and/or technical support duties to assist in the collection and processing of delinquent taxes and fees. The Treasurer's Office serves an ethnically and culturally diverse population that includes a large number of Spanish-speaking clients for whom English is a second language. Major Job Duties: * Contacting debtors regarding delinquent accounts; * Responding to inquiries received in person, by email, and by phone in a call center environment; * Explaining tax policies and regulations; * Conducting skip traces to determine debtors' whereabouts; * Referring customers to other County and/or State agencies as needed; * Submitting delinquent accounts for lien and seizure when appropriate; and * Providing customer service to internal and external stakeholders. The ideal candidate will possess effective verbal and written communication skills, flexibility, coachability, self-motivation, critical-thinking skills, and the ability to remain professional and calm in a high-volume, fast-paced customer service environment. This position requires the ability to identify and prioritize the tasks necessary to meet long- and short-term objectives, as well as effective time management and multitasking skills to achieve these objectives. The candidate must be adept with technology and with using multiple complex systems at the same time, while eliciting, understanding, and advocating for customer needs. Minimum Qualifications: * High School Diploma/GED, or equivalent; and * Considerable experience (2 years) in an administrative support position or customer service experience working directly with the public. Substitution: Additional education may be substituted for the experience requirement. Desirable Qualifications: Preference may be given to applicants with one or more of the following: * Bilingual proficiency (English and Spanish); * Experience using a wide range of software programs, specifically Microsoft Office Suite or similar software; and/or * Experience working directly with the public explaining policies, procedures and/or tax regulations to customers. Special Requirements Background Check: A pre-employment criminal records check will be conducted. It will include checks of the following: criminal record, driving record, education, professional licensure, and credit history. You will be required to sign a release authorizing the County to obtain your background information. Please complete each section of the application including the supplemental questions. Your responses to the supplemental questions are required because they provide us with specific information necessary to evaluate your qualifications for this position. These responses are considered part of the selection process. A resume may be attached; however, it will not substitute for a completed application. Incomplete applications will not be considered. Please do not write "see resume" as a response to the questions. Additional Information Work Hours: This is not a remote opportunity; employees are expected to be in the office full time. Normal office hours are Monday through Friday from 8:00 a.m. to 5:00 p.m. All positions within the Treasurer's Office are Non-Bargaining (NB). The official title for this position is Treasury Specialist II. All Treasury Specialist II's are eligible for County government employee benefits that include health, dental, vacation and sick leave, commuter transportation subsidies, tuition reimbursement, as well as a generous retirement plan. For more information on Arlington County's generous benefits and retirement plan, click here. Arlington County is committed to advancing diversity, equity, access, and inclusion across all our services, activities, and programs. Learn more about our commitment. #LI-Onsite

ASRC Federal is seeking a Clinical Research Associate with experience in site initiation, site monitoring and site close-out visits for clinical studies. Join our growing team and let's defeat cancer in our lifetime. Responsibilities Monitor clinical studies and investigational sites for adherence to study protocols, GCP/ICH guidelines, and company SOPs. Prepare and conduct Site Initiation Visits (SIV), routine Site Monitoring Visits (SMV), and Site Closeout Visits (SCV) for assigned studies. Review clinical study documents, including Informed Consent Forms (ICF), source documents, patient instruction guides, and Case Report Forms (CRFs). Assist in identifying investigational sites and perform site qualification visits as needed. Monitor clinical study progress and prepare progress reports for investigators (e.g., patient accrual, audit findings, data transmission, and reporting activities). Ensure data quality from clinical sites and assist in resolving patient eligibility issues and protocol deviations. Serve as a liaison and resource for assigned investigational sites. Analyze monitoring findings, identify trends, and provide recommendations for process improvements to management. Requirements Bachelor's degree in a Life Science, Biological Science or other related medical degree and 3+ years of related work experience. Experience in conducting site initiation visits, monitoring visits and close-out visits required. Quality assurance or experience in finding "gaps" in processes so training and "best practices" , SOPs can be initiated is a plus. Working knowledge of clinical research processes, regulatory requirements, data collection requirements and methodologies. Knowledge of Good Clinical Practices/ICH and SOPs SoCRA or ACRP certifications are desirable as is a Master's degree in a Life Science, Biological Science or related Medical field Ability to obtain a Public Trust clearance

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning training programs speak for themselves. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Role Overview: Join our dynamic team and lead the charge in supporting our client's pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders. Key Responsibilities: Vendor Management: Lead the contracting with third-party lab service providers for assay development and validation. Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts. Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines. Support the development of novel Bioanalytical processes. Documentation & Data: Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy. Sample Logistics: Track and reconcile sample testing, resolving any issues that arise. Contribute to cleaning and finalizing data. Qualifications: Education: BA/BS or higher in medical science or a related field, plus 5+ years (BA/BS) or 2+ years (MS) of clinical trial management experience. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Experience: Familiarity with clinical bioanalysis outsourcing operations. Knowledge of GLP, GCP guidelines, and vendor audits. Understanding of clinical trial design and data outputs. Experience with sample collection instructions and lab manuals. Proficiency in data transfer agreements/specifications and data reconciliation. Skills: Strong organizational and analytical skills. Excellent written/verbal communication. Ability to work both independently and as part of a team. Proficiency with Excel and other interactive programs. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in Maryland is $63,000.00-$120,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

At Digital Infuzion, we believe that by equipping researchers with rapid insights and providers with tailored, on-demand data, we can help people lead better, healthier lives. We harness innovative health-IT solutions and advanced bioinformatics to make meaningful impacts in patient care. Our culture is creative, open, and growth-oriented, guided by core values that shape how we lead and deliver: Outcomes First - Focus on what matters most and makes timely, informed decisions. Innovative - Embrace creativity and continuous improvement to drive novel solutions. Radical Candor - Communicate openly and honestly, balancing direct feedback with genuine care. Never Satisfied - Pursue excellence and growth beyond the status quo. Resilient - Adapt and persevere through challenges, turning obstacles into opportunities. If you are passionate about leveraging technology to advance healthcare and thrive in a collaborative, mission-driven environment, this may be the opportunity for you. Position Summary The Project Director, Clinical Research Solutions serves as the senior leader responsible for the successful execution of a strategic clinical research support program for the National Institute on Aging (NIA). This role provides scientific, operational, and programmatic leadership for a multidisciplinary team delivering comprehensive project management, regulatory oversight, data and safety monitoring coordination, analytics, and recruitment support for Alzheimer's disease and aging-related studies. The Project Director drives strategic alignment between NIA's research mission and Digital Infuzion's delivery excellence-driving quality, compliance, and innovation across all clinical research support functions. This includes oversight of the Data and Safety Monitoring Board (DSMB) and Observational Study Monitoring Board (OSMB) operations, stewardship of CROMS (Clinical Research Operations and Management System) data integrity, and advancement of inclusive recruitment strategies for underrepresented populations in clinical research. This leadership role directly contributes to NIA's mission to improve the health and well-being of older adults through innovative, inclusive, and high-quality clinical research. Reporting directly to the Vice President of Operations, Client Delivery Services, the Project Director collaborates with Practice Area Leads, Technical Operations leadership, and cross-functional teams to ensure excellence in execution, financial performance, and client satisfaction while driving innovation across the health-research ecosystem. Key Responsibilities Program and Project Leadership Serve as the primary contact and strategic partner between the sponsor and the organization. Leverage scientific and/or clinical subject-matter expertise to strengthen decision-making, enhance delivery quality, and reinforce Digital Infuzion's status as a trusted research and health-innovation partner. Build strategic partnerships across teams and stakeholders to drive alignment and integrated delivery. Trusted advisor to NIA leadership, known for proactive engagement, clear communication, and consistent delivery of strategic value-positioning Digital Infuzion as a long-term partner in advancing the Institute's mission Lead project planning, execution, and delivery, ensuring adherence to standards and procedures. Establish, communicate, and manage customer expectations with transparency and accountability. Drives financial stewardship and operational efficiency, proactively managing budgets, contracts, and scope alignment. Drive proactive risk identification, issue management, and resolution. Champions a culture of compliance and quality, ensuring all activities align with SOPs, ICH-GCP, regulatory, and contract-specific requirements. Leads a multidisciplinary team spanning clinical operations, data management, and analytics functions. Leverages coaching, recognition, and professional development to sustain a high-performing, mission-aligned team. Portfolio Oversight and Organizational Leadership Provide enterprise-level oversight across a portfolio of clinical research and data-driven initiatives, ensuring alignment with organizational strategy and client priorities. Reinforces stakeholder trust by translating complex program performance into clear, actionable insights and demonstrated results Lead governance and performance management efforts - driving standardization, transparency, and best practices across projects. Empowers and develops emerging leaders, fostering a culture of ownership, accountability, and continuous learning that drives delivery excellence and client satisfaction. Partner with senior leadership to translate portfolio insights into strategic direction and operational priorities. Serve as a thought leader and internal SME, contributing to white papers, strategic proposals, and business development initiatives. Identify and advance opportunities for innovation, growth, and cross-program synergy within the Clinical Research Solutions portfolio. Applies digital health innovation, AI, and data-driven strategies to enhance clinical trial oversight and participant engagement. Leverages coaching, recognition, and professional development to sustain a high-performing, mission-aligned team. Continuous Improvement and Innovation Support the adoption of AI and advanced analytics tools to enhance project visibility and performance insights. Champions process innovation and continuous improvement initiatives that elevate performance, quality, and scalability. Drives innovation in project and program management through digital transformation, automation, and data-driven insight. Champion knowledge sharing and continuous learning across teams. Requirements Master's or Doctoral degree in health, life sciences field 10 + years' experience managing complex, large-scale projects or programs within the federal government, healthcare, or life-sciences sectors. Provide strategic direction and oversight for successful delivery of multiple related projects (time, cost, quality). Proven ability to oversee multiple related initiatives (development, research, or service delivery). Strong financial acumen with experience managing contracts, budgets, and resources. Exceptional presentation, communication, and interpersonal skills. Strong analytical, problem-solving, and strategic-thinking abilities. Ability to translate complex scientific and operational processes into actionable delivery plans. Qualifications and Experience Doctoral degree (PhD, DrPH, MD, PharmD, or DSc) in a biomedical, clinical, or health-related field. Acceptable Alternative: Master's degree (MPH, MS, MHA, or MBA) with significant clinical research management experience. 10-12 years of progressively responsible experience in clinical research administration, operations, or program management. Preferred: 15+ years of progressive experience, including at least 5 years in senior leadership roles overseeing large, federally funded clinical research programs. Proven experience supporting or managing Data and Safety Monitoring Boards (DSMBs) or similar oversight committees, with a strong understanding of the clinical trial lifecycle and study operations. PMP certification or equivalent project/program management credential. Demonstrated experience managing or collaborating with external partners, grantees, vendors, or stakeholders in a research or technical environment. Familiarity with Agile, Scrum, or hybrid project-management frameworks. Digital Infuzion does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor per Federal laws. We can provide reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact Human Resources at **********************. The decision on granting reasonable accommodation will be made on a case-by-case basis.

(ID: 2025-0644) Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Biospecimen Coordinator - Organoid Research to join our vibrant team at the National Institutes of Health (NIH) supporting the Standardized Organoid Model Initiative in Frederick, MD. Benefits We Offer: 100% Medical, Dental & Vision Coverage for Employees Paid Time Off and Paid Holidays 401K match up to 5% Educational Benefits for Career Growth Employee Referral Bonus Flexible Spending Accounts: Healthcare (FSA) Parking Reimbursement Account (PRK) Dependent Care Assistant Program (DCAP) Transportation Reimbursement Account (TRN) Overview The Biospecimen Coordinator - Organoid Research is responsible for coordinating and managing the full lifecycle of biospecimens used in organoid-based research, including receipt, processing, storage, and outbound shipping. Responsibilities Handle donor-derived tissues (e.g., biopsies, blood), supporting organoid culture workflows (isolation, expansion, cryopreservation), and conducting quality control to ensure sample integrity. Maintain detailed records in LIMS, ensures regulatory compliance (e.g., HIPAA, GLP), and collaborates with procurement teams, lab staff, and project managers to meet study timelines and protocol requirements. Oversee logistics for biospecimen procurement and distribution, ensuring proper documentation, cold chain management, and adherence to IATA shipping standards. Responsible for reporting for metrics purposes, all sample shipments. Required Qualifications Bachelor's or Master's degree in Cell Biology, Molecular Biology, Biotechnology, or a related field, with 3-5 years of relevant experience in a laboratory, CRO, or biopharmaceutical setting focused on biospecimen handling, organoid culture, or translational research Familiarity with laboratory information management systems (LIMS), digital sample tracking, and tissue dissociation techniques is essential Work in a BSL-2 facility may be required; training will be provided Strong attention to detail, the ability to follow protocols rigorously, and clear, collaborative communication skills are critical Manage multiple tasks in a regulated, time-sensitive environment while maintaining high-quality standards Preferred Qualifications Certification in IATA Dangerous Goods Shipping for handling and transporting biological specimens Familiarity with regulated laboratory environments, including GLP or CLIA standards, is highly valued Working knowledge of IRB protocols, HIPAA regulations, and ethical requirements for handling human biospecimens, as well as experience supporting cross-functional teams or contributing to biospecimen workflows within biobanking, drug discovery, or clinical research programs Expertise in Excel is preferred Experience developing a universal ID system, potentially a labeling process is preferred Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or . This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed. The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate. Accessibility: If you need an accommodation as part of the employment process please contact: ******************** This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location. #IND Salary Range $75,000 - $85,000 USD

Job DescriptionDescriptionBiomedical/Clinical Research Information Specialist WHO WE ARE: STAHL Companies provides the Program Management for its Channel of Commercial Technology companies in Government that consist of Small Businesses and New Technology start-ups. STAHL advocates for policies that can improve government services and maintain our government's competitive advantage, by bringing more technology into government programs. STAHL Companies advocates on behalf of our nation's innovative, new technology and small businesses looking to work with the U.S. government. We do this by aligning the voice of our small business members with advocacy for change in federal policy that will make the government market more accessible to small businesses and the commercial technology ecosystem. The Channel's founding Technical Board Members include former government leaders and IT executives passionate about bringing best-of-breed technology to the government. We are seeking a skilled and experienced Biomedical/Clinical Research Information Specialist to join our team! Responsibilities:Content expertise and editorial efforts are required in the following subject areas: · Drugs, agents, reagents and carcinogens; · Clinical procedures, treatment, prevention, imaging, and related topics; · Diseases, findings, and related clinical and molecular abnormalities; · Genomics, biomarkers, public health, demography. Qualifications:· A minimum of five (5) years of progressively responsible experience in the individual's field of study and specialization. · Augments or directs teams providing high level content analysis, design, integration, documentation and implementation advise on complex issues requiring an advanced specialist degree-level knowledge in the individual's field of study. · Designs and prepares technical reports and documentation to support findings and study results. · Prepares executive-level briefings, including charts and graphs to present findings to client managers. · For editors working on clinical terminology, degrees in nursing, pharmacology/pharmacy, public health, medicine, biology, molecular biology, or related field is required. · Experience with terminology creation and modeling, data standards, and best terminology practice is desirable. *Position is contingent upon award. Work Location: NCI Location, USA To know more about the company, visit Stahl Companies (stahlusa.us) Key ResponsibilitiesContent expertise and editorial efforts are required in the following subject areas: · Drugs, agents, reagents and carcinogens; · Clinical procedures, treatment, prevention, imaging, and related topics; · Diseases, findings, and related clinical and molecular abnormalities; · Genomics, biomarkers, public health, demography.

Prometheus Federal Services (PFS) is a trusted partner of federal health agencies, seeking a Clinical Research Coordinator to support our clients within the Department of Veterans Affairs. In this role, you will be at the forefront of advancing clinical research initiatives that directly impact the health and well-being of our nation's Veterans. You will coordinate and manage critical aspects of clinical studies, ensuring compliance with regulatory standards while delivering exceptional support to patients and research teams. This is an opportunity to combine your expertise in clinical research with a mission-driven organization dedicated to improving healthcare outcomes for our clients. Essential Duties and Responsibilities Coordinate day-to-day clinical research activities, including regulatory submissions, patient screening enrollment, and data management. Assist patients in completing study activities, ensuring a positive and supportive experience. Plan and facilitate research team meetings to align objectives and maintain progress. Monitor and evaluate research timelines and deliverables in collaboration with the Principal Investigator (PI). Ensure compliance with regulatory, ethical, and institutional guidelines throughout all phases of the research study. Maintain and document accurate, detailed records of research activities for audit readiness. Communicate and present research updates and findings to stakeholders in a clear and timely manner. Minimum Qualifications Bachelor's degree in Nursing, Health Science, Public Health, Healthcare Administration, or a related field. Minimum four (4) years of experience in clinical research coordination; oncology experience is strongly preferred. Experience implementing clinical research regulatory guidelines and compliance standards. Experience with electronic medical records. Experience with REDCap and Excel (pivot tables, data visualization) is a plus. Exceptional organizational, interpersonal, and communication skills. Work independently and collaboratively in a fast-paced environment. Solve problems effectively with strong attention to detail. Authorized to work in the U.S. indefinitely without sponsorship. Ability to obtain public trust. Preferred Qualification Master's degree in Nursing, Health Science, Public Health, Healthcare Administration Experience supporting federal healthcare organizations, especially within the VA. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. This position may be subject to client or government vaccination, policy, or requirements that may change from time to time. The work location is flexible if the company approves it, except that the position may not be performed remotely from Colorado. PFS offers a comprehensive benefits package that includes health insurance, dental and vision insurance, flexible spending accounts, disability insurance, life insurance, a retirement plan, paid time off, remote work, and other benefits to accommodate what matters most to you and your family. Learn more about PFS Benefits. Note: PFS benefits, compensation, and bonuses are subject to eligibility requirements and other applicable plan or program terms. Powered by JazzHR k0VTBm6bnx

Job Description Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Job Description This role will be key in developing internal Clinical Operations systems and procedures to improve all aspects of Clinical Study related business processes and will work very closely with the Associate Director of Clinical Operations along with the US Site Head. Location: Gaithersburg, Maryland Responsibilities: Participates in the planning, implementation and management of pre-IND through Phase I-II clinical trials, in collaboration with Contract Research Organization (CRO) partners, if applicable. Manage day to day activities of all aspects of clinical studies including study plans, timelines, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams. Contributes to development of RFPs and participates in selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. Provides updates on project status and deliverables to Clinical Project Management leads (deliverables may include project status reports, vendor reports, trackers, meeting minutes/action items). Contributes to development of study budget(s). Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans, whether developed internally or externally. Oversees investigator recruitment/selection and the conduct of trials at investigative sites. Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and ensures CRO quality within trials, if applicable. Plans, executes, and leads Investigators Meetings, if applicable. Contributes to development of internal Clinical Operations systems to improve business processes. Develops relationships with Key Opinion Leaders as applicable for key I-Mab development programs. Prepare and present study or project specific updates. Represent Project Management & Clinical Operations in partnered development programs. Mentors junior level Clinical Research Associates. Qualifications: Life sciences or medical background is required. 6+ years of industry experience (biotech/pharma) with at least 2-5 (will determine level) years of project management experience Experience in Phase 1 Oncology trials. Strong understanding of ICH, GCP and relevant regulatory requirements The ability to work with cross-functional teams in a matrix environment is a must Strong organizational and time management skills; detailed oriented; excellent interpersonal and communication skills Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.

Job Description Our client is seeking a Senior Clinical Project Manager / Associate Director, Clinical Operations to lead the clinical operations for their early-phase celiac disease trial. This role offers the opportunity to manage a CRO team, oversee study timelines and budgets, and contribute to protocol design and trial strategy. The position is remote-friendly, reports to the CMO, and provides a clear path to grow into a Director of Clinical Operations as the company's pipeline expands post-merger. Ideal candidates have experience leading teams at CROs, managing early-phase studies, and driving complex clinical programs to deliver results. Main purpose of the job: To assist with the clinical activities to support our clients' portfolio of research and development projects. All activities carried out with regard to time, cost, and quality, and in accordance with SOPs, ICH/ GCP guidelines, and local regulations. Key responsibilities include: Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines, and all applicable laws and regulations. Study team coordination and leadership. Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality. Responsibility for the preparation of study documentation and coordination of document review, e.g., protocols, IBs, DSURs, ICFs, CSRs. Selection and oversight of assigned CROs, vendors, or contract monitors (CRAs), as appropriate. Selection of suitable clinical sites in collaboration with other members of the Barinthus study team or CROs, as appropriate. Periodic co- ‐monitoring with contract CRAs or CROs as necessary for each study, to ensure high-quality monitoring and site management. Set up and management of clinical contracts (including Clinical Site Agreements). Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions. Preparation of study budgets, forecasting, and accruals. Thorough documentation of study team activities, decisions, actions, and risk assessments. Active management of clinical trials supply requirements in collaboration with 3rd party storage & distribution specialists. Oversight of Sponsor Oversight File and/or TMF creation and maintenance by Clinical Trial Administrator, to ensure ‘inspection- ‐ readiness' of documentation at all times. Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies. Assist with departmental development work, e.g., SOP review/writing and process improvements initiatives. Develop and maintain relations with sites and KOLs. Other Responsibilities of the Role: Personal abilities and traits: Demonstrates personal drive and goal orientation. Self-motivated, taking personal pride in delivering on personal and corporate objectives. Enthusiastic and flexible to change. Demonstrates strong organisational and prioritisation skills to manage a diverse workload. Able to interact with individuals at all levels of the organisation. A highly effective communicator, both orally and in writing, with an eye for detail/ accuracy. Reliable and trustworthy, able to work with minimal supervision. Qualifications and/or experience required to perform the role Essential knowledge, experience, and skills: BSc or equivalent. Clinical study management experience within a pharmaceutical, biotech, or CRO company. Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc). Excellent written and verbal communication and presentation skills. Excellent organisational and interpersonal skills. Ability to manage multiple priorities within one or across different projects. Excellent working knowledge of GCP and current clinical trial legislation. Thorough knowledge of the clinical development process, ideally from first-in-human through to regulatory filing for marketing. Ability to travel in the USA and abroad periodically if needed. Ability to work in a dynamic small team environment. Desired skills: Experience in early phase (I- ‐II) studies. Working with GMO experience. CRA/monitoring experience. Experience of EDC and eTMF; comfortable with electronic systems, e.g., CTMS. Autoimmune Diseases and Immunology experience.

is 100% onsite in Hagerstown, MD Make a meaningful impact in advancing clinical research at Meritus Health. Meritus Health is seeking a highly skilled and motivated Clinical Research Specialist to support the planning, coordination, and daily operations of clinical research trials across our health system. In this vital role, you'll work directly with the Associate Dean of Research, Principal Investigators, sponsors, and regulatory agencies to ensure that every study is conducted with excellence, accuracy, and integrity. What You Will Do As a Clinical Research Specialist, you will: Lead & Support Clinical Research Activities Assist with the development, implementation, and evaluation of clinical practices for sponsored and Meritus-initiated clinical trials. Ensure the ethical conduct of research and compliance with all regulatory standards (IRB, FDA, GCP). Manage Regulatory Compliance Prepare and maintain submissions for federal, state, and local regulatory bodies, including Institutional Review Boards. Develop and oversee effective systems for required reporting and documentation. Execute Research Protocols Follow clinical trial protocols in alignment with Good Clinical Practice (GCP). Support ongoing quality assurance and quality control processes. Drive Research Growth Identify new research opportunities that align with our system's resources and population. Support the expansion and development of investigator-initiated and sponsored research programs. Engage Participants & the Community Assist in participant recruitment and enrollment. Promote research initiatives to providers, community members, payors, and internal teams. Support Education & Professional Development Assist with training, mentoring, and supporting clinical research staff, providers, residents, faculty, and students. Maintain up-to-date training in human subjects protection, GCP, and other compliance standards. Manage Financial & Operational Aspects Support the review and management of clinical trial budgets and financial documentation. What You Bring Bachelor's degree required; Master's preferred (Background in nursing, therapy, or other healthcare-related program ideal.) Licensed Registered Nurse preferred 3-5 years of clinical research experience ACRP Clinical Trials Coordinator Certification OR minimum of 5 years of documented experience performing clinical trials Strong knowledge of: Good Clinical Practice (GCP) IRB processes FDA regulatory requirements Excellent verbal and written communication skills Ability to collaborate effectively with physicians, clinical staff, and multidisciplinary teams Strong organizational skills and the ability to manage multiple tasks simultaneously Caring for Our Team We offer a comprehensive benefits package to support our employees' well-being and professional growth. Benefits include health, dental, and vision insurance available starting the 1st of the month following date of hire, along with life insurance, & short and long-term disability coverage. Paid Time Off begins accruing from day one, and we also provide a 401k plan, an education assistance program, and an employee assistance program. Additionally, employees working evening, night, or weekend shifts may be eligible for a shift differential, adding even more value to your role. Happy to Help At Meritus, we believe in a collaborative and caring work environment. Interactions are an opportunity to learn, listen and to be there for one another. Therefore, we provide warm welcomes, hospitality-driven closures, and are always Happy to Help.

**Req ID:** RQ210393 **Type of Requisition:** Regular **Clearance Level Must Be Able to Obtain:** None **Public Trust/Other Required:** NACLC (T3) **Job Family:** Ancillary Health **Skills:** Clinical Research,Data Compilation,Research Protocols **Experience:** 4 + years of related experience **US Citizenship Required:** Yes **Job Description:** **GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.** **The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.** **The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH.** **This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.** **HOW YOU WILL MAKE AN IMPACT:** **Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities.** **Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports** **Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor's regulatory file.** **Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.** **Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites.** **Prepare and/or review laboratory sample analysis reports** **WHAT YOU'LL NEED TO SUCCEED:** **Bachelors degree, 4+ year's experience supporting clinical research** **Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file.** **Experience providing remote evaluation of the study data** **Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.** **Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.** **Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.** **WHAT GDIT CAN OFFER YOU:** **Challenging work that makes a real impact on the world around you** **Internal mobility team dedicated to helping you own your career** **401K with company match** **Diverse, highly collaborative teams** **Professional development, education assistance, certification and training opportunities** **\#GDITHealth** **\#militaryhealth** **\#GDITLabScienceJobs** **\#GDITFedHealthJobs** The likely salary range for this position is $59,500 - $80,500. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. Join our Talent Community to stay up to date on our career opportunities and events at ******************** Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

Vantor is forging the new frontier of spatial intelligence, helping decision makers and operators navigate what's happening now and shape what's coming next. Vantor is a place for problem solvers, changemakers, and go-getters-where people are working together to help our customers see the world differently, and in doing so, be seen differently. Come be part of a mission, not just a job, where you can: Shape your own future, build the next big thing, and change the world. To be eligible for this position, you must be a U.S. Person, defined as a U.S. citizen, permanent resident, Asylee, or Refugee. Note on Cleared Roles: If this position requires an active U.S. Government security clearance, applicants who do not currently hold the required clearance will not be eligible for consideration. Employment for cleared roles is contingent upon verification of clearance status. Export Control/ITAR: Certain roles may be subject to U.S. export control laws, requiring U.S. person status as defined by 8 U.S.C. 1324b(a)(3). Please review the job details below. Do you enjoy turning real-world problems into mathematical solutions and applying AI/ML to geospatial intelligence (GEOINT) data? We tackle our customers' toughest challenges with innovative approaches and custom tools. We're seeking an experienced AI/ML researcher to work across the full workflow-from data acquisition and model development to pipeline evaluation, application prototyping, and hardware-based solution implementation. Responsibilities: Contribute to multi-discipline AI/ML research teams using multi-INT data (with emphasis on GEOINT) to design, implement, and evaluate machine learning solutions. Engineer and transform diverse data types to support all phases of the AI/ML workflow. Architect, develop, and integrate novel AI/ML models (e.g., computer vision, semantic activity detection, geospatial analytics, signal processing). Design, implement, and assess edge-based AI/ML solutions across hardware and software stacks. Stay current on AI/ML advances from industry and academia, applying them to government mission challenges. Provide subject matter expertise, mentoring, and strategic advice to government and internal teams on AI/ML trends, approaches, and delivery strategies. Communicate progress, results, risks, and challenges to government clients, partners, and project leadership. Support program execution by integrating diverse data science skillsets, managing sprint projections, assessing risks, and occasionally traveling for meetings and demonstrations. Minimum Qualifications: Must be a U.S. citizen with an active TS/SCI and the ability to obtain a CI polygraph. Bachelor's degree in Data Science, Engineering, Math, Physics, Computer Science, Applied Geography, or related field, with 7+ years of experience designing, developing, testing, and deploying AI/ML models across diverse data types. Minimum 2 years of experience with synthetic training data generation, low-shot learning, and robust ML, as well as cloud-based platforms (e.g., AWS, Azure) and AI/ML services (e.g., SageMaker, Watson Studio). Experience working with remote sensing and GEOINT datasets, including EO, RF, and SAR imagery, and familiarity with government collection platforms. Ability to work effectively with geographically distributed teams and onsite in Herndon, VA or Westminster, CO. Strong communication skills demonstrated through technical writing (e.g., proposals, white papers, academic publications) and speaking engagements (e.g., briefings, conference presentations), with excellent organizational skills and attention to detail. Preferred Qualifications: Advanced degree (M.S. or Ph.D.) in Data Science, Engineering, Math, Physics, Computer Science, Applied Geography, or a related field. Proficiency with the Python data science stack (e.g., numpy, pandas, matplotlib, sklearn) and geospatial libraries (e.g., gdal, geopandas, shapely). Experience with deep learning algorithms for image science (e.g., YOLO, SSD, DetectNet) and containerization platforms (e.g., Docker, Kubernetes, OpenShift, Cloud Foundry). Strong background working in Linux environments and using version control tools such as Git and GitLab. Ability to design and implement compute hardware and infrastructure solutions to support both edge and backend AI/ML applications. Experience with communication hardware and signal processing, including antenna design/implementation, RF signal propagation, and software-defined radios. Pay Transparency: In support of pay transparency at Vantor, we disclose salary ranges on all U.S. job postings. The successful candidate's starting pay will fall within the salary range provided below and is determined based on job-related factors, including, but not limited to, the experience, qualifications, knowledge, skills, geographic work location, and market conditions. Candidates with the minimum necessary experience, qualifications, knowledge, and skillsets for the position should not expect to receive the upper end of the pay range. ● The base pay for this position within Colorado is: $124,000.00 - $206,000.00 annually. ● The base pay for this position within the Washington, DC metropolitan area is: $137,000.00 - $228,000.00 annually. For all other states, we use geographic cost of labor as an input to develop market-driven ranges for our roles, and as such, each location where we hire may have a different range. Benefits: Vantor offers a competitive total rewards package that goes beyond the standard, including a robust 401(k) with company match, mental health resources, and unique perks like student loan repayment assistance, adoption reimbursement and pet insurance to support all aspects of your life. You can find more information on our benefits at: ****************************** The application window is three days from the date the job is posted and will remain posted until a qualified candidate has been identified for hire. If the job is reposted regardless of reason, it will remain posted three days from the date the job is reposted and will remain reposted until a qualified candidate has been identified for hire. The date of posting can be found on Vantor's Career page at the top of each job posting. To apply, submit your application via Vantor's Career page. EEO Policy: Vantor is an equal opportunity employer committed to an inclusive workplace. We believe in fostering an environment where all team members feel respected, valued, and encouraged to share their ideas. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender identity, sexual orientation, disability, protected veteran status, age, or any other characteristic protected by law.

* Telework Type: Part-Time Telework Extraordinary teams building inspiring projects: Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have created jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place. Differentiated by the quality of our people and our relentless drive to deliver the most successful outcomes, we align our capabilities to our customers' objectives to create a lasting positive impact. We serve the Infrastructure; Nuclear, Security & Environmental; Energy; Mining & Metals, and the Manufacturing and Technology markets. Our services span from initial planning and investment, through start-up and operations. Core to Bechtel is our Vision, Values and Commitments. They are what we believe, what customers can expect, and how we deliver. Learn more about our extraordinary teams building inspiring projects in our Impact Report. Project Overview: Several combined cycle power projects are currently planned to be developed and executed by Bechtel over the next 5-10 years. During the development phase of these projects, teams will be organized to support multiple projects concurrently. Following project award, dedicated project teams will be formed, and separate Power Island Coordinators will be assigned to each combined cycle project to manage the interfaces between the Power Island equipment vendor and the Bechtel project team. Job Summary: A combined cycle project has numerous interfaces both physical and data between the power island equipment (gas turbine, steam turbine, HRSG) and the Bechtel scope. The Power Island Coordinator will be responsible for managing the exchange of information between Bechtel and the Power Island vendor, and for resolving these interfaces to support the project schedule. You will create tracking lists, setup and run action item meetings, and coordinate model reviews as necessary to facilitate the exchange of information between the two parties. Your coordination and support will ensure that complex technical issues are resolved, internal clients are satisfied, and project needs are met. You will interface with the Power Island Coordinators for other projects to identify areas of common interest and to provide technical guidance and support. This position is designated as part-time telework per our global telework policy and will require at least three days of in-person attendance per week at the assigned office or project. Weekly in-person schedules will be determined by the individual and their supervisor, in consultation with functional or project leadership #LI-HB1 Major Responsibilities: * You will create and maintain the action item list coordinating the exchange of information between Bechtel and the Power Island Equipment Vendor on a combined cycle project * You will conduct periodic action item list meetings as needed to go over the status of pending items and maintain the schedule for completing them * You will coordinate and participate in CADD model review meetings for the project to identify interfaces (both physical and data) between Bechtel and the Power Island equipment vendor that need to be coordinated and resolved * You will provide oversight and direction to Power island coordinators for other combined cycle projects Education and Experience Requirements: Requires bachelor's degree (or international equivalent) and 10-13 years of relevant experience or 14-17 years of relevant work experience Required Knowledge and Skills: * Strong written and oral communication skills. * Ability to summarize interface requirements in an actionable format. * Ability to use Microsoft Word, Excel, and TEAMS to create meeting minutes, action item lists, and setup virtual meetings Ability to read project schedules and identify key engineering milestones to maintain critical path * Knowledge of the engineering process and understanding of inputs required to complete the major design deliverables required for construction * Prior experience performing design work on combined cycle power plants is required * Experience with Aconex * Knowledge of major power plant equipment and the key interfaces to design supporting structures and auxiliary systems * Highly organized individual capable of working in a collaborative team environment * Ability to organize and conduct interface coordination meetings Total Rewards/Benefits: For decades, Bechtel has worked to inspire the next generation of employees and beyond! Because our teams face some of the world's toughest challenges, we offer robust benefits to ensure our people thrive. Whether it is advancing careers, delivering programs to enhance our culture, or providing time to recharge, Bechtel has the benefits to build a legacy of sustainable growth. Learn more at Bechtel Total Rewards Diverse teams build the extraordinary: As a global company, Bechtel has long been home to a vibrant multitude of nationalities, cultures, ethnicities, and life experiences. This diversity has made us a more trusted partner, more effective problem solvers and innovators, and a more attractive destination for leading talent. We are committed to being a company where every colleague feels that they belong-where colleagues feel part of "One Team," respected and rewarded for what they bring, supported in pursuing their goals, invested in our values and purpose, and treated equitably. Click here to learn more about the people who power our legacy. Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, disability, citizenship status (except as authorized by law), protected veteran status, genetic information, and any other characteristic protected by federal, state or local law. Applicants with a disability, who require a reasonable accommodation for any part of the application or hiring process, may e-mail their request to ********************

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $26-30/h. Essential Responsibilities and Duties: Assists Director with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelor's Degree, preferred. 1-2 years of coordinating experience, high volume of clinical trials, preferably with psych/CNS trials Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

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. Minimum Education B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 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 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. * 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

The Research Coordinator provides assistance to the Principal Investigator and Study Team coordinating research activities that may include recruiting research participants, data collection and management and other research activities as assigned. The Research Coordinator will assist with report generation and project close-out support. This is a part time (20 hours per week) position that will be required to work on site at the Uniformed Services University in Bethesda, MD. A government background check will be administered. Salary Range $22.00 - $28.00. Salaries are determined based on several factors including external market data, internal equity, and the candidate's related knowledge, skills, and abilities for the position. Qualifications Bachelor's degree or equivalent work experience required 2-4 years' experience in clinical research preferred 2-4 years' non-profit, research, or healthcare experience desired Demonstrate competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software Knowledge of CFR, GCP and ICH guidelines Visa sponsorship not available US Citizenship required Responsibilities Participant recruitment, consent forms Promote safety and confidentiality of research participants at all times Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives Document all correspondence and communication pertinent to the research Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization

Job Family: Nurse (Digital) Travel Required: None Clearance Required: Ability to Obtain Public Trust What You Will Do: We are currently searching for a Research Nurse to work in the transplant and cellular therapy with the Division of Intramural Research at NIH. In this position, the individual will have a critical role in the various protocol development, implementation, and evaluation activities. This role will also serve as a crucial part of a dynamic clinical team for several simultaneous research studies. This is a full-time opportunity located in Bethesda, MD. * Educate and counsel patients participating in clinical trials, including, following up with patients in long-term studies and providing Q&A time via phone to patients. * Work with a diverse team of health care providers, such as, physicians, advanced practitioners, patient care coordinators, and data managers to service patients and conduct clinical research. * Facilitate patient recruitment and enrollment into ongoing clinical trials. * Ensure compliance with protocol and regulatory requirements. * Support ongoing research and clinical programs at NHLBI and NIH Clinical Center. * Manage clinical research data and providing data quality assurance. What You Will Need: * Bachelor's Degree in Nursing. * Active, current license as a registered nurse in the United States, the Commonwealth of Puerto Rico, or a territory of the United States. * A minimum of TWO (2) years of clinical research experience in transplant, hematology, and/or oncology. * Strong background in clinical research, preferably with experience beyond healthy volunteer studies * Demonstrated ability to work with both healthy volunteers and medically complex patients * Experience supporting Phase 1 and Phase 2 clinical trials * Skilled in managing the unique needs of very ill patients in a research setting What Would Be Nice To Have: * Prior experience at the NIH Clinical Center is highly preferred * Excellent interpersonal and communication skills for working in a multidisciplinary team * Ability to adapt to fast-paced, high-acuity research environments * Previous experience working with the National Institute of Health (NIH) preferred. The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs. What We Offer: Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: * Medical, Rx, Dental & Vision Insurance * Personal and Family Sick Time & Company Paid Holidays * Parental Leave * 401(k) Retirement Plan * Group Term Life and Travel Assistance * Voluntary Life and AD&D Insurance * Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts * Transit and Parking Commuter Benefits * Short-Term & Long-Term Disability * Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities * Employee Referral Program * Corporate Sponsored Events & Community Outreach * Care.com annual membership * Employee Assistance Program * Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.) * Position may be eligible for a discretionary variable incentive bonus About Guidehouse Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at ************** or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or ************************. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process. If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact *************************. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties. Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Clinical Research Coordinator (CRC) 📍 Location: Pikesville, MD | 🏥 Site Name: Headlands Research - Pharmasite | 🕒 Full-Time Are you an experienced clinical research professional with a passion for advancing medicine? Join a leading, integrated clinical research network dedicated to high-quality data, patient-centered care, and innovation in clinical trials. We're seeking a Clinical Research Coordinator (CRC) for our clinical research site located in Pikesville, MD. The CRC will manage and execute Phase I-IV clinical studies in accordance with FDA regulations, GCP/ICH guidelines, and sponsor protocols. This role is ideal for someone who thrives in a fast-paced environment and is eager to make an impact in the clinical research industry. Type: Regular Full-time Employee Schedule: Mondays through Fridays, 8:00am - 5:00pm Location: Onsite in Pikesville, MD (no capabilities for remote or hybrid work) Reports to: Site Director Benefits: Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more. 💼 What We Offer Competitive pay + annual performance incentives Medical, dental, and vision insurance 401(k) plan with company match Paid time off (PTO) and company holidays A mission-driven culture focused on advancing medicine and improving patient outcomes 🚀 Why Join Us? You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster-while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you. Responsibilities: Coordinate all aspects of assigned clinical trials from site initiation to study close-out Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs Manage subject recruitment, informed consent, and retention strategies Ensure timely data entry and resolution of EDC queries Report and follow up on all adverse events, serious adverse events, and deviations Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders Prepare for and participate in monitoring visits, audits, and inspections Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained) Attend investigator meetings and provide cross-functional support as needed Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control Requirements: 🎓 Education & Experience Requirements Required: High school diploma or GED Experience: Minimum of 1 year of experience as a Clinical Research Coordinator OR Minimum of 2 years of college within a health-related program OR Licensed as a Licensed Practical Nurse (LPN) or higher OR Bachelor's degree in a health or scientific-related program 🧠 Skills & Qualifications Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures Proficiency in medical terminology and clinical documentation practices Strong interpersonal, verbal, and written communication skills Organized, detail-oriented, and capable of managing multiple priorities Proficient in Microsoft Office and other clinical research systems 📬 Apply now to become a part of a team that's changing the future of healthcare-one trial at a time.