div>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.
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.
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.
Gaithersburg, MD5 days ago
The position requires extensive experience in biopharmaceutical quality assurance, particularly in GCP environments, and a strong understanding of ICH guidelines and FDA compliance for investigational late-stage/commercial cell therapy products. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
This role is hybrid (2 days on-site) and will play a key role in supporting clinical trial operations by ensuring the TMF is accurate, compliant and audit-ready. Qualifications of the Clinical Trial Specialist: 1-3+ years of regulatory submission/IRB experience working for a CRO, pharmaceutical/biotech, or research institution.
Bethesda, Maryland30+ days ago
li>Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc. Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
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.
li>Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad.
Gaithersburg, MD30+ days ago
Regulatory Sciences Clinical Sciences Commercial as necessary • Monitors and is responsible for communicating the spend versus budget for clinical supply program activities and materials leads Clinical Supply Chain and Finance review meetings and flags variances • Reviews changes to contracts with vendors and Contracts Manager if necessary • May manage the procurement of IMP and ancillary materials as it relates to programs • Manages and reviews inventory levels at manufacturing facilities to ensure supplies are adequate according to the demand • Provides support to ensure compliance with internal Quality Management system including writing and reviewing SOPs • When required contributes to and reviews documents for submissions to regulators or ethics committees • Contributes to and reviews supply and technical agreements ensuring Quality oversight • Initiates Quality Events where appropriate and investigate and perform root cause analysis and execution of associated CAPAs • May deputize for the Senior Director Clinical Supply Chain when absent as required • Supports the selection of suppliers and assist with the preparation of documentation associated with the assessment evaluation and management of CMOs distribution depots and other contractors involved with clinical supplies • Drives forward procedural change to improve compliance with SOPs regulations. KEY RESPONSIBILITIES • Sets up the clinical supply chain strategy and strategic direction of supply for clinical programs • Leads Clinical Supply Chain Managers Specialists responsible for the production packaging labelling and distribution of drug supplies for clinical studies providing direction around study supply strategies ensuring plans are appropriately aligned with business needs • Ensures the supply chain strategy maximizes efficiency of supply consistently balancing cost and risk • Aggregates the demand for Clinical program supply and ensures it is included in the Immunocore CMC and External Manufacturing supply planning process • Produces and implements a Clinical Supply Chain Program Strategy document documenting the supply chain program strategy • Implements continuous improvement aimed at scalability and applicability across programs • Supports requests for supply for external sponsor studies compassionate use and access programs collaborating with and seeking expert input from cross functional subject matter experts e.g.
Other: Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defined by the FMS quality goals, and compliance with the pertinent company policies and procedures. Demonstrated leadership competencies and management skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management and decision making.
p>ESSENTIAL FUNCTIONS: • Plan, prepare, and deliver quality instruction in clinical, lecture, and/or laboratory (if applicable) format based on the approved course outline by selecting and utilizing a variety of approved course materials and teaching methods that address all learning modalities to ensure that the needs of individual students in the program are met.
SUMMARY:
The Obstetric (OB) clinical instructor performs as the expert in the clinical setting and is entrusted with imparting the knowledge and skills each student needs to be successful by providing quality delivery of assigned courses while ensuring that all students become competent in the course objectives.
Rockville, MD30+ days ago
Summary: The Clinical Support Associate assists the Clinical Operations Team within a limited scope of defined responsibilities in carrying out one of the assigned roles (collection/processing of laboratory samples, data entry of clinical data or administrative/front office support). Data Entry Responsibilities: Assist in the conduct of clinical trials by performing data entry tasks in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs under the direction of the Clinical Research Team.