Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Inizio Engage has a long-standing partnership with a leading biotechnology organization across Commercial, Patient Solutions and Medical Affairs businesses.
li>Establishes develops and maintains effective relationships working agreements and quality partnerships within the shared decision-making model and within the model of care to ensure quality patient care across the continuum and to secure resources to support evidence based patient care. Functions as a facilitator and innovator for state-of-the-art clinical care with direct involvement in implementing and evaluating new techniques and equipment for safety cost-effectiveness and benefits related to clinical practice.
Baltimore, MD30+ days ago
We are seeking a team-oriented Clinical Research Physician who thrives in a fast-paced, highly specialized research environment and is passionate about mentoring and supporting clinical staff. This role offers the opportunity to contribute to clinical research, collaborate with cross-functional teams and engage directly with sponsors and partners.
Rockville, MD30+ days ago
The successful candidate will lead/co lead clinical research activities in support of three key initiatives: - Clinical research supporting activities within the Clinical Development Group (phase I - III trials) and regulatory filing of pipeline products.
Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates.
Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook. Responsibilities of the In-House Clinical Research Associate include: Review and process essential regulatory documents received from clinical trial sites.
Silver Spring, Maryland6 days ago
Holy Cross Hospital, in Silver Spring, is one of the largest hospitals in Maryland, and Holy Cross Germantown Hospital is the first hospital in the nation built on a community college campus, enhanced by an educational partnership. Position Purpose:
The Clinical Research Coordinator coordinates pharmaceutical company, National Cancer Institute (NCI), multisite and in-house protocol activities for the Cancer Program and principal investigators.
Silver Spring, MD23 days ago
Holy Cross Hospital, in Silver Spring, is one of the largest hospitals in Maryland, and Holy Cross Germantown Hospital is the first hospital in the nation built on a community college campus, enhanced by an educational partnership. Position Purpose: The Clinical Research Coordinator coordinates pharmaceutical company, National Cancer Institute (NCI), multisite and in-house protocol activities for the Cancer Program and principal investigators.
Silver Spring, MD30+ days ago
Critical thinking skills ability to analyze clinical research protocols, assess study budgets, and analyze clinical trial contracts including payment terms. Excellent communication skills, ability to interact across the organization, and negotiate with clinical research sponsor/ clinical research organization personnel in a professional manner to represent CNH.
Rockville, MD30+ days ago
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. 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.
We are seeking applications from aspiring clinical researchers (and clinicians) who are committed to cutting-edge work using community-based, neurodiversity affirming, qualitative, and neuroimaging (EEG/ERP, fMRI) methods to improve quality of life for autistic people. 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.
p>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. As a Clinical Research Assistant, PRN (Registered Nurse), you'll play a key role in delivering life-changing research opportunities to participants but with the flexibility to work when and where it fits your life.
Silver Spring, MD23 days ago
Build financial console in OnCore CTMS including protocol amendments and updates to ensure accurate charge capture and segregation of research charges for all research related patient care as well as ancillary services such as investigational pharmacy. 3 years experience working in a clinical research environment including a stand-alone research site, a research department, or in research administration such as a centralized research office, or with an institutional review board (Required).
Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. " Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
Baltimore, Maryland30+ days ago
We are seeking a team‑oriented Clinical Research Physician who thrives in a fast‑paced, highly specialized research environment and is passionate about mentoring and supporting clinical staff. This role offers the opportunity to contribute to clinical research, collaborate with cross-functional teams and engage directly with sponsors and partners.
Leads in Proactive Risk Management through close collaboration with cross functional leads in identification of Critical to Quality (CTQ) factors; supporting responsible risk owners in developing mitigating actions; analyzing key risk indicators and data trends into actionable insights. The Clinical Development Risk and Compliance Management (CDRCM) Department provides expertise in risk and compliance Management at Project and Account level, working with Clinical Development Operations and Leadership and Sponsors to optimize clinical trial delivery safeguarding participant safety, data integrity and regulatory compliance.
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: responsible for the scientific operations of research program studies, leading scientific research studies, executing the day-to-day operations of clinical research, and monitoring the safety of human subjects for a research organization. At one of the identified vacancies, This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. This role requires a licensed Registered Nurse with proven clinical experience, preferably in a research setting, who is capable of working independently and collaboratively to ensure the safety, well-being, and informed consent of all research participants.
Baltimore, MD30+ days ago
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Craft and convey clear, impactful and engaging messages that tell a holistic story. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. This flexible, per-diem role is ideal for licensed nurses who want to gain or expand their experience in clinical research while contributing to studies that make a global impact.
Piper Companies is seeking a Clinical Research Associate (CRA) to support the operational delivery of clinical trials across infectious disease, oncology, and cardiology programs. Collaborate cross-functionally with CRAs, CTMs, QA, and Data Management teams to resolve issues, mitigate risks, and maintain compliance with ICH-GCP and SOPs.
Silver Spring, MD5 days ago
Holy Cross Hospital, in Silver Spring, is one of the largest hospitals in Maryland, and Holy Cross Germantown Hospital is the first hospital in the nation built on a community college campus, enhanced by an educational partnership. Specialty care, home care and hospice services round out Holy Cross Health's high-quality and coordinated continuum of care that aims to improve health and let you live life on your own terms.
li>Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies.
At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Physician Assistants (PA) functions under the direction and guidance of a licensed physician to ensure the safety of study participants.
Baltimore, MD30+ days ago
li>Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies.
At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Nurse Practitioner (NP) functions under the direction and guidance of a licensed physician to ensure the safety of study participants.
li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience..
li>As part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: - Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.
li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience..
li>As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: - Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
Gaithersburg, MD30+ days ago
Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. Essential Skills/Experience: Education/Experience required: Associate Director level : BS Life Sciences degree or simiilar, 7+ yrs medical writing experience in pharmaceutical industry or CRO.
li>Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of and performing job functions in compliance with rules regulations policies and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner. Ensure the safety and welfare of study subjects to include symptom review and management appropriate referral and follow-up and ongoing contact with subjects and primary care providers regarding current health status and response to study interventions.
Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation • Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports • Contribute to contract review and negotiations with outside vendors and study sites or laboratories • Mentor CTMs and CRAs • Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: • Bachelors degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): • Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6.
Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). Applicants who are motivated in developing skills through onsite education in trauma informed care, harm reduction, and working with patients with a substance use disorder are encouraged to apply.
Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). This position is within the Maryland Addiction Consultation Service team, working to support evaluation and continuous quality improvement as part of a team that provides statewide consultation, training and technical assistance to health care providers and teams in an effort to increase access to evidence based treatment for substance use disorders.
Baltimore, MD30+ days ago
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.
Baltimore, MD30+ days ago
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.
Within the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials. - Assists human subjects' research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the NMRC CTC in conjunction with senior staff.
Baltimore, MD30+ days ago
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. As a Clinical Research Assistant, PRN (Registered Nurse), you'll play a key role in delivering life-changing research opportunities to participants but with the flexibility to work when and where it fits your life.
Baltimore, MD30+ days ago
Job Overview TheClinical Research Pharmacy Technician supports clinical research activities by assisting in the receipt preparation dispensing storage accountability and documentation of investigational and non-investigational products in a regulated research pharmacy setting. Founded in 2004 Pharmaron has invested in its people and facilities and established a broad spectrum of research development and manufacturing service capabilities throughout the entire drug discovery preclinical and clinical development process across multiple therapeutic modalities including small molecules biologics and CGT products.
The Clinical Research Assistant II will contribute to research activities including patient recruitment, screening, data collection, protocol adherence, and regulatory compliance for a clinical trial that combines brain stimulation, pharmacotherapy, and behavioral interventions. HJF is seeking a Clinical Research Assistant II - DARPA to support clinical research evaluating novel interventions to improve mental health and prevent suicide in active-duty service members.
Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. This individual will provide strategic and operational leadership to monitoring teams, drive continuous improvement, and serve as a subject matter expert in site management and monitoring practices.
Baltimore, MD30+ days ago
p>This general interest posting is designed for experienced Clinical Research Coordinators (CRCs) who may not see a current opening that aligns with their location, but want to be considered for future opportunities across our growing network of clinical research sites nationwide. They play a hands-on role in advancing new therapies, supporting patients through clinical trials, and ensuring studies are conducted with the highest level of quality and care.
This Phase I study conducted at the Uniformed Services University Translational Medicine Unit, is a randomized, placebo-controlled, double-blind, 4-period crossover study comparing LT-120, an intranasal esketamine nasal spray, with intravenous racemic ketamine under fasted conditions. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.