NAMSA

Research Analyst

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and overall study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
• Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process.
• Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s).
• Assists in preparing sites for audits and in resolving audit action items.
• Supports sites during audits remotely and/or onsite as needed.
• Participates in meetings with prospective clients.
• Supports training and mentoring of CRAs during remote and onsite visits.
• Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents.
• Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development.
• Supports Core Laboratory management and may serve as the primary contact.
• Supports data management in CRF development, validation rules, UAT, review data, and identify trends, and other reporting/analysis tasks.
• Performs and summarizes literature searches.
• Registers trials on Clinicaltrials.gov

Senior Clinical Research Associate

Community Manager

• Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity and hemocompatibility).
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
• Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• May assist Associates with performing routine test article/product preparation according to work instructions.
• May communicate test schedule updates to NAMSA Associates or management as needed.
• Maintains ancillary records (logbooks, worksheets).
• May be required to perform personal gowning, environmental testing, and submitting organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
• Adheres to established company processes.
• May provide administrative support.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain of custody documentation for test article tracking.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• May assist in ordering and/or stocking supplies subject to approval.
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks, media preparation, or cell work.
• Other duties as assigned.

Lab Technician, In Vitro

• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays, pharmacology studies, and toxicology studies.
• Performs the extraction process on prepared samples in accordance with ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed.
• Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors, Quality Assurance and NAMSA Associates about issues, results, or audits.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Performs ethylene oxide processing of study-related materials through the in-house sterilizer.
• Adheres to established company processes.
• Completes chain of custody documentation for test article tracking.
• Responsible for performing routine equipment microbiological monitoring.
• Maintains ancillary records (logbooks, worksheets).
• Communicates test schedule updates to NAMSA Associates or management as needed.
• Responsible for the assessment and completion of GLP study article data retention/archival.
• May assist in receipt and release of lab supplies and inventory.
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks and media preparation.
• Other duties as assigned.

Lab Tech

Business Development Rep

• Develops and implements territory sales strategies with the ultimate goal of positioning NAMSA as the Clinical Research Organization of choice.
• Achieves assigned sales goals in defined territory for NAMSA’s CRO Services business.
• Creates regular and effective interaction with existing and prospective clients, including field visits, phone, email, local or client specific meetings / events, national and global meetings / events, and any other tactical sales activity directed at growth of NAMSA’s CRO Services business
• Establishes, maintains, and enhances customer relationships.
• Recommends pricing and / or operational strategies to secure large pieces of new business
• Responsible for adding and maintaining information in CRM software per departmental procedures.
• Works with Strategic Partnership group to develop and implement NAMSA multi-year agreements.
• Supports manager and other sales & marketing professionals in developing new market opportunities in designated accounts and geographies.
• Prepares and delivers effective sales presentations and proposals to ensure successful outcome of sales interactions and transactions.
• Responsible for leading the Bid Defense preparation and meeting following the established process.
• Works with Pre-Clinical Specialists sales teams as necessary to sell new Clinical business.
• Works closely with proposal and sales advisory teams on proposals.
• Other duties as assigned.

Business Development Executive – CRO

• Works on assigned studies to ensure human subject protection, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies per contracts, SOPs, and regulatory guidelines.
• Conducts on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits as needed.
• Serves as primary point of contact for site questions related to study enrollment, conduct, and close-out; liaises with study team members.
• Communicates site performance, trends, deficiencies, and concerns to site investigators and project team via verbal and written communication.
• Supports study start-up activities, quality reviews of study documents, and distribution of site activation letters.
• Performs study-related training and manages development/maintenance of study documents, processes, and systems as assigned.
• Ensures quality and completeness of central and site master files; tracks and maintains required study documents and renewals.
• Tracks study site and overall study metrics including enrollment, deviations, adverse events, and trial master file maintenance.
• Attends internal and external meetings; provides progress reports and visit documentation.
• May support safety activities such as narrative writing and managing CEC/DSMB; OUS: prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.

Field Clinical Research Associate

Clinical Research

• Develops and maintains foundational study materials and tools (protocol with study design, training slides, informed consent, investigator brochure, instructions for use, templates, forms, SOPs, processes, etc.), and coordinates team and client review processes.
• Creates and manages study tracking tools (metrics, systems, reporting).
• Supports internal clinical team members: protocol training, client and site management and oversight, escalation and resolution of site issues.
• In collaboration with Project Management, supports all project-level duties: o Establishes and monitors project metrics o Tracks project deliverables o Communicates project status to clients and internal teams o Facilitates team and sponsor meetings o Follows cross-functional team action items to resolution
• Drives all site activities from start-up through close-out: o Site selection and qualification o IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.) o Regulatory document collection and review o Budget and contract negotiations o Site initiation (on-site or remote training, follow-up, activation) o Provides site training, when necessary o Screening and enrollment o Monitors notable trends/potential issues in data entry (quality and completion), general site compliance to the protocol, GCP, SOP, and other applicable guidelines, adverse events, protocol deviations o Investigator site file maintenance o Works with CTAs to ensure sites have all materials necessary to conduct study o Site engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.) o Monitors monitoring activities (e.g., scheduling, follow-up, action item resolution, etc.) o Monitors quality, frequency and appropriate documentation of site communications o Troubleshoots site and team issues; considers and potentially implements CAPAs o Supports close-out efforts by ensuring all data and regulatory action items are adequately resolved, investigator responsibilities relayed, IRB/EC reporting complete.
• In collaboration with relevant functional groups, drives all project-level deliverables: o Ensures project plans and other TMF level documents are current and consistent (data management plan, system specifications, safety and core lab manuals, etc.); initiates and coordinates revisions, when necessary o Ensures Trial Master File quality and overall audit readiness at study and site levels o Assists with the development, testing and implementation of study systems: EDC, CTMS, TMF, device accountability, etc. o Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data. o Assists in the submission and review of all clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.) o Develops clinical study report • General project compliance: ensures that adherence to industry standards and regulatory requirements, including but not exclusive to contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines. • Travels as needed (typically between 20-30%) to meet project milestones. • Leads multidisciplinary clinical projects by managing the above-listed tasks for simple to moderately complex studies. • Effectively manages cross-functional groups. • Understands investigational product(s) including high-level understanding of the Medical Device Development Process. • Reviews monitoring reports. • Conducts and summarizes literature searches according to applicable requirements. • Assists in planning and conduct of site and sponsor clinical audits. • Assists with FDA/competent authority inspections, sponsor/vendor audits of NAMSA. • Organizes and manages Investigator Meetings. • Selects and manages Core Laboratories. • Safety committee (e.g. DSMB or CEC) selection and management. Qualifications & Technical Competencies: • Bachelor’s degree or equivalent experience in a related field, with a minimum 3 years of relevant clinical trial and/or monitoring experience; and • Project management experience. • Fluency in English and local language, if different, required. • Knowledge of Good Clinical Practices. • Knowledge of regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly. • Familiarity with the clinical trial process • Understanding of site escalation process for compliance issues. • Multidiscipline (at least 2 therapeutic areas) therapeutic knowledge. • Familiarity with medical device development process from pre-clinical to commercialization. • Understanding of the role of data management and biostatistics in the clinical trial process. • Understanding of the type and quality of data needed from a clinical trial and how it should be presented. • Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel (and to persuade them to do what is needed). • Ability to prepare slides and present complex information professionally and clearly; strong speaking skills. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Clinical Study Manager

Compliance

Sets the strategic philosophy and direction for NAMSA’s global quality and regulatory compliance systems applicable to all functions and entities.
Owns the quality direction including the research, monitoring and communication of current and changing regulations including applicable laws and guidelines.(e.g., US and ex-US GxPs, ISO requirements).
Develops and maintains external relationships with key opinion leaders, medical directors and regulatory officials.
Designs and implements systems and controls to ensure consistency and compliance with applicable regulatory requirements, across the global NAMSA network.
Selects, trains, and supervises staff to perform quality engineering, quality assurance, quality systems and quality/regulatory compliance functions consistent with strategic plans for ongoing implementation of the NAMSA Quality Policy.
Oversees the Corporate Quality System ensuring compliance with all national and international standards and regulations, including but not limited to US FDA, CFDA and applicable ISO standards for the Company.
Develops and directs the internal quality system support functions for NAMSA, including Document Control, Archives/Records, Training, CAPA, Complaints, Management Review, Business Software Validations, Internal/External compliance Audits, Supplier Approval and Supplier Audits, Quality Engineering, and GxP Quality Data Audit/Review/Approval.
Works cooperatively with NAMSA Leaders to implement programs to improve overall quality and increase regulatory compliance. Assures test validation and audits accurately assesses ongoing performance and detects quality problems. Promptly notify management of significant quality system or technical problems.
Directs and accomplishes financial objectives for the Quality organization by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions; effective utilization of resources, equipment (engineering) and space.
Acts as the primary interface with the US FDA and other regulatory authorities globally for compliance inspections.
Develops and maintains a three-year staffing and space requirement plan.
Advises and assists clients regarding quality and regulatory concerns.