Clinical research associate jobs in Towson, MD

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

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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: *****************************************************

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.

Job DescriptionBenefits: Competitive salary Flexible schedule Health insurance Job Type: Full-time Salary Range: $90,000 - $125,000 per year Experience Required: 3+ years in clinical supervision or social work About the Role: We are seeking an LCSW-C Clinical Project Manager to oversee behavioral health plans and provide clinical supervision for direct care staff. This role ensures high-quality trauma-informed services for youth in care. Key Responsibilities: Supervise 1:1 support staff and provide weekly clinical oversight. Review and manage youth behavioral health plans. Ensure compliance with state guidelines and best practices. Coordinate with caseworkers and caregivers to improve care plans. Requirements: Licensed Certified Social Worker - Clinical (LCSW-C) required. 3+ years of clinical management experience in youth services. Strong leadership, case management, and crisis intervention skills. Familiarity with child welfare and trauma-informed care. Perks & Benefits: Competitive salary & performance bonuses Paid professional development & certifications Health, dental, and vision insurance Supportive & mission-driven work environment

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.

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).

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. 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.

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.

Are you passionate about improving health systems and advancing HIV/AIDS care around the world? GSSHealth is looking for a dynamic, mission-driven Francophone Clinical Project Manager to help lead innovative HIV/AIDS programs across multiple countries. This is an exciting opportunity to work at the intersection of global health, clinical excellence, and systems strengthening with the chance to see the direct impact of your work on communities around the globe. As a key member of our team, you will lead coordination of impactful projects, work closely with in-country partners and health care stakeholders, and global funders to support program implementation, strengthen health services, and drive sustainable improvements in HIV/AIDS care. Candidates must be legally authorized to work in the United States at the time of application. We are unable to provide visa sponsorship. Candidate must be based in Maryland, Pennsylvania or Delaware within reasonable commuting distance of Baltimore, Maryland. Responsibilities: Lead and coordinate HIV/AIDS clinical projects in multiple countries where GSSHealth is active Oversee and support in-country subcontractors to ensure successful project delivery Work directly with healthcare stakeholders to plan and conduct site assessments and capacity-building initiatives Guide program improvement plans, and contribute to high-quality patient care outcomes Represent GSSHealth in meetings and build strong, collaborative relationships Coordinate clinical site visits (approx. 1-3 weeks per visit), providing actionable insights and follow-up Monitor program adherence to HIV/AIDS clinical policies and best practices Track progress, manage timelines, and prepare reports that communicate impact to funders and partners Oversee that data collection of HIV indicators (MER) is ongoing and that accurate reporting is conducted in timely fashion Required Qualifications: Master's degree in public health, epidemiology, health administration or bioscience preferred; or Bachelor's degree with a major or minor in bioscience or a related field required plus 5+ years of related work experience. Fluency in French and proficiency in English (written and spoken) 6+ years of program management experience Prior experience delivering PEPFAR, Global Fund, or other donor-funded HIV programs Strong data monitoring, financial, and compliance systems Excellent written and verbal communication skills Proficiency in Microsoft Office Suite Strong track record in HIV clinical care, laboratory systems, and community outreach, and differentiated service delivery models Company Description: Global Scientific Solutions for Health (GSSHealth) is a global health consulting company dedicated to strengthening global health and clinical programs, clinical laboratories and laboratory networks in resource-limited countries. Our team members provide tailored solutions in the areas of strategic planning, training and technical assistance, program improvements, quality assurance, and monitoring and evaluation. Equal Employment Opportunity: GSSHealth 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, parental status, military service, or other non-merit factor. Candidates for positions under specific contracts will be subject to background/security investigations. Such investigations may include criminal record and credit history checks. Salary Description $90,000.00-$110,000.00

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a **_Sr. Clinical Research Coordinator_** who will oversee the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems. **Specific Duties & Responsibilities** + Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study design. + Develop standard operating procedures and data collection forms from protocol(s). + Develop consent form(s) for clinical trials based on protocol(s). + Prepare materials for submission to IRB. + Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services. + Ensure compliance with all protocols, procedures, and applicable regulations. + Participate in developing the study budget. + Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies. + Set up a data collection system and ensure the validity of study data. + Organize and quality control study data + Perform self-audits and/or audit other sites. + Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals. + Conduct literature searches to provide background information. + Abstract and index information based on knowledge of subject matter. + Other duties as assigned. **Minimum Qualifications** + Bachelor's Degree in a related field. + Three years of related experience. + Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. **Preferred Qualifications** + Master's Degree in a related field Classified Title: Sr. Clinical Research Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Monday to Friday 8:30 am - 5pm FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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.

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.

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 Associate will provide clinical and research services to clinical trial subjects participating in Infectious Diseases studies under the supervision and direction of Dr. Princy Kumar. The incumbent must be able to manage and coordinate complex COVID-19 studies in accordance with established protocols and guidelines. This position is responsible for monitoring and screening patients and administering investigational therapies for all clinical trials. The incumbent should exhibit a high level of clinical skills and the ability to make decisions in response to unique clinical situations. The Clinical Research Associate works directly with clinical trial subjects. Will provide professional care for patients following established standards and practices, order and interpret diagnostic test. The incumbent will also complete all study related documentation and ensure that standard clinical procedures and protocol regulations are met. Additional duties include, but are not limited to: * Maintains a robust understanding of research processes * Partners with clinical staff to help with documentation and data requirements of research functions * Interact with the Clinical Trial Office, Pharmacy, Clinical Research Coordinators, Financial Administrator, and Regulator Specialists * Monitoring and screening of patients and administering investigational therapies under close supervision of Principal Investigator and Co-Investigators * Effectively communicates with trial subjects, internal resources and support teams to ensure objectives are met and regulatory compliance is maintained * Collaborates with clinical and research resources to identify and develop process improvements * Participates in cross functional teams to gather clinical and research needs in order to identify effective solutions Work Interactions The Clinical Research Associate will work directly with the Division Chief, Clinical Trial Principal Investigators, the Clinical Trial Unit research manager and staff. This position will interact with the Georgetown Clinical Trial Office, Pharmacy, CRC, and Pharma representatives. Must possess the ability to remain calm and perform effectively in emergency situations. Must possess the ability to communicate effectively; ability to work under pressure and respond to multiple demands; and must be sensitive to confidential nature of the job. Requirements and Qualifications * Knowledge of professional nursing theory and practices to assess, plan, implement, and evaluate patient care. * Must have a Bachelor's degree and 5+ years of experience or equivalent relevant work experience; Master's Degree in a related field is a plus * Experience in research protocols and quality assurance * Experience in a University Medical setting is helpful * Knowledge of and sensitivity to a myriad of issues related to HIV infection and COVID-19 is critical * Ability to react calmly and effectively in emergency situations is preferred. * Ability to work in a Clinical Research setting * Familiarity with Infectious Diseases Clinical Trials * Strong knowledge and familiarity of Microsoft Office applications * Excellent problem-solving skills * Excellent communication skills * General knowledge of clinical research 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 and AAP positions can be found on the Department of Human Resources website: *************************************************** Working Conditions: Office setting. Sedentary. Salary and Benefits: Up to $87,558 per year, 40 hours a week. Pay Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is: $47,586.00 - $87,558.13 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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs * Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

OPS Consulting is seeking an experienced Research Support Administrator Level 1 to work in the following locations: Baltimore, MD College Park, MD Required Experience: The Research Support Administrator will provide administrative and security support to the project. The Research Support Administrator will also coordinate with visitors, travel, meetings, and special handling of VIP guests. Additional responsibilities will include: Answer telephones, greet and log-in visitors, and distribute mail. Procure supplies for research lab. Management of the time accounting system. Preform record management. Plan and Schedule activities for facility maintenance and improvements. Coordination of schedules, meetings and facility tours; arrange for travel and management of travel expense tracking system. Qualifications: A minimum of five (5) years of experience providing administrative support is required. Knowledge and proficiency in the use of computer application software such as MS Word, Excel, and PowerPoint is required. Security Clearance: A current government clearance, background investigation, and polygraph are required. We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected class. The Swift Group and Subsidiaries are an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class. Pay Range: $49,996.80 - $290,004.00 Pay ranges are a general guideline and not intended as a guaranteed and/or implied final compensation or salary for this job opening. Determination of official compensation or salary relies on several different factors including, but not limited to: level of position, complexity of job responsibilities, geographic location, work experience, education, certifications, Federal Government contract labor categories, and contract wage rates. At The Swift Group and Subsidiaries, you will receive comprehensive benefits including but not limited to: healthcare, wellness, financial, retirement, education, and time off benefits.

Sr. Clinical Research Coordinator - (2500032W) Description The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical 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 individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. Qualifications Minimum EducationB. A. /B. S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's degree with at least 2 years of relevant experience (Required) Minimum Work ExperienceAt least 3 years of experience with a bachelor's degree. (Required) OrAt least 2 years of experience with a master's degree. (Required) Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure. Familiarity with databases, data collection tools and data analysis methods. Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission. Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment. Required Licenses and CertificationsInternal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required) External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (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 guidances (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, organizes and 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, appreciates a diverse workplace 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. Identifies and resolves issues and challenges with appropriate input and oversight. Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs. Creates standard operating procedures (SOPs), and implements operational plans. Provides oversight and training to study team members for a variety of studies. Develops study documents, including consent forms and protocols. Participant Enrollment Adheres 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. 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. Study Management Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation. 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. Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials. gov postings, Certificate of Confidentiality applications and scholarly presentations and publications. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks. 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. 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 Cancer & Immunology RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 40Job Posting: Nov 25, 2025, 6:11:53 PMFull-Time Salary Range: 54516. 8 - 90854. 4

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.

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.