NAMSA

• 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 over all 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.

• Support clients during every step of the product development lifecycle. • Collaborate with internal teams to ensure compliance with safety standards. • Develop and maintain test methods for medical devices.

• Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Case Safety Reports (ICSRs). • Performs intake, review, analysis, and data entry of ICSRs into tracking system, regulatory report, and/or Safety database. • Writes ICSR narratives. • Interprets reported event information, including medical conditions, laboratory results, and medical procedures. • Correctly determines relevant follow-up data required for ICSR completion. • Distributes notifications of ICSR to study team/Sponsor. • Participates in ICSR reconciliation between Clinical database and Safety database as required. • Provides content for ongoing development and maintenance of Standard Operating Procedures. • Independently establishes work priorities with minimal input from Management. • Maintains tracking tools for departmental key performance/quality indicator metrics. • Attends study team meetings and company staff meetings, providing status updates and tracking action items as needed. • Assists in quality assurance activities including audits. • Serves as mentor and coach to less experienced Safety team members and non-Safety staff.

• Support clients during every step of the product development lifecycle and beyond.

• Contract Workers are not paid through NAMSA Payroll. • They are either paid through Accounts Payable or an Outside Firm.

Role Description - Participate in meetings with prospective clients. - Provide scope of project and relevant information to support the creation of proposals. - Offer opportunities to clients for expansion of MRO services to be provided by NAMSA. - Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993-1, ISO 10993-17, and ISO 14971, for submissions to FDA and other regulatory agencies. - Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards. - Working knowledge of FDA and EU MDD and other global medical device regulations and/or biologics regulations, ISO 10993 series, and 14971. - Ensure biocompatibility studies are in compliance with most recent regulatory requirements. - Performs and summarizes Clinical Evaluations. - Provide technical support to lab staff. - Advise clients on technical issues related to biocompatibility and material characterization. - Develop proposals for Biological Safety projects. - Perform biocompatibility gap analysis and write clear concise report. - Performs and summarizes literature searches. - Facilitate the collection of test data from other NAMSA entities as they relate to a specific project. - Evaluates and determines biological relevance of unexpected results. Qualifications - Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or - Master’s or Doctorate degree or equivalent experience in a related field, and a minimum of 2 years of relevant experience. - DABT Certification Required - Knowledge of and experience with Microsoft Word - Write and review complex documents Requirements - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to talk or hear. - The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. - The employee must occasionally lift and/or move up to 25 pounds. - Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. - Extensive use of a computer keyboard. Benefits - NAMSA is an equal employment opportunity company. - NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

• Develop and maintain biological safety documents and reports • Assess/audit compliance of biocompatibility and material characterization results to applicable standards • Collaborate with teams for regulatory compliance and safety standards

Role Description - 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. Qualifications - Fluency in English and local language, if different, required. - Higher education degree or equivalent education, training, and experience. - Preferred 5 years clinical trial experience. - Preferred 3 years monitoring experience. - Preferred 1 year device trial experience. - Able to work independently once trained. - Good verbal and written communication skills. - Strong organizational skills. - Basic computer proficiency. - Understanding of clinical research processes and regulations. - Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required. Working Conditions - Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. - Extensive use of a computer keyboard. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

• Supervises day-to-day activities of the Global Client Success team, that manages client experience with laboratory submissions and interactions with NAMSA client portals, including and not limited to, NAMSA 360, Connect, Flightlog, WOS, and future acquisitions • Coordinates and supervises workload distribution for CSS, Sr CSS, and CSM associates. • Develops, delivers, and maintains training programs for new hires and ongoing skill development, including training documents, SOPs, job aids, and knowledge-base content. • Oversees the laboratory submission help desk function, ensuring timely triage and resolution of inquiries related to portals, proposals, submissions, complaints, and feedback • Provides escalation and advanced case support for complex client issues, ensuring timely resolution and clear communication • Supports deployment and operational maintenance of the new client portal including UAT, internal training coordination, case tracking, and client adoption monitoring. • Responsible for implementing NAMSA client portals and transitioning client to a single portal in support of the Global Operating model • Monitors and reports operational KPIs of the team (including, but not limited to case management, response time, effectiveness of proposal follow up), identifying trends and recommending process or training improvements. • Serves as a liaison between Commercial, IT, and Laboratory Operations to support system enhancements, process updates, client needs, and cross-functional communication. • Identifies and escalates operational or client-related issues appropriately, providing guidance and support to team members. • Other duties as assigned.

• Comply with the Safety Team Roles and Responsibilities • Perform medical review and interpretation of adverse events and device deficiencies reported by clinical trial investigators • Ensure timely and accurate assessment of safety data in compliance with regulatory requirements, study protocols, and internal SOPs. • Write and review adverse event narratives, ensuring clinical accuracy and consistency. Determine relevant follow-up information and ensure completeness of adverse event documentation. • Utilize MedDRA for medical coding and ensure consistency with MedDRA Points to Consider. • Act as a Medical expert for coordination of CEC and DSMB activities and oversee preparation of materials for CEC, DSMB and/or other Committee reviews • Review clinical study data, adverse event reporting, and clinical study design, to safeguard the rights, safety and wellbeing of all trial subjects • Assess safety events, conforming to regulatory requirements and protocol-specific definitions. • Provide medical input into the design of clinical study protocols, including safety endpoints, inclusion/exclusion criteria, and risk mitigation strategies. • Oversee development of study-specific safety documents such as Safety Plan and CEC/DMC charter. • Review and contribute to clinical evaluation reports, clinical study reports, other aggregate safety reports, and regulatory submissions. • Advise on protocol amendments based on emerging safety data or regulatory feedback. • Attend project meetings • Attend and participate in internal meetings as scheduled. • Perform continual assessment of adherence to timelines for all groups involved. • Serve as in-house Medical Subject Matter Expert for NAMSA projects. • For assigned projects, maintain relationship with appropriate C-level / VP-level team member from sponsor side (this is separate from project management discussions which will be the responsibility of the NAMSA Project Manager). • Support business development by contributing to proposals, attending sales meetings, and presenting medical capabilities to prospective clients • Participate in client meetings, including kick-off and safety review meetings, and provide expert input on safety-related matters. • Serve as a clinical and scientific advisor to clients, offering strategic guidance on safety, regulatory, and clinical development issues. • Collaborate with biostatistics, regulatory, medical writing, and clinical operations teams to ensure alignment on safety deliverables. • Participate in the design, testing, and maintenance of electronic systems supporting safety services. • Mentor and coach safety associates and non-medical team members. • Develop and deliver training sessions on therapeutic areas, safety processes, and protocol-specific topics. • Support onboarding new hires and contribute to departmental knowledge-sharing initiatives. • Participate in internal and external audits, inspections, and quality assurance activities. • Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines. • Maintain and contribute to the development of SOPs, templates, and training materials. • Track and manage safety metrics and key performance indicators. • Support accurate invoicing and budget tracking for safety-related services. • Ensure timely documentation of hours and expenses in accordance with company policy.