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 Field Clinical Research Associate

Community Manager

• Develops Business analysis, design, configuration, coordination, implementation and support.
• Develops specific system deployment activities that include functional requirements definition, detailed technical design, system configuration, conversion and integration requirements, unit testing, systems test, acceptance test, go-live, and production turn over.
• Participates in process improvements including, formulation and definition of technical scope and objectives of project, analysis of current business practices, processes, and systems, define detailed project tasks, and participating on a matrix team to execute projects.
• Actively participates in enterprise-wide change management processes for requested system revisions.
• Provides escalated technical support for enterprise client areas on existing business systems.
• Tracks and addresses bugs identified in testing and production.
• Conceptualizes new processes and systems that add value to NAMSA business units.
• Provides user stories to multi-disciplinary teams and define the business-driven acceptance criteria.
• Proactively engages technical Associates to schedule and execute required tasks.
• Cultivates and maintains successful relationships between Information Technology team and Associates from various NAMSA organizations globally.
• Documents system for turnover and training of NAMSA Associates, Information Technology peers, and Service Desk.
• Performs other duties as assigned.

Business System Analyst – Various Platforms

Clinical Operations

• Assists in planning, and coordinating both global and regional clinical, biostatistics and data management operational activities of the Clinical Department as applicable.
• Manages select Clinical Associates within the Clinical Department.
• Allocates workload for all clinical, biostatistics and data management projects; May take on all the duties and responsibilities of one or more of the functions of the direct reports and/or lead projects, as needed
• Confirms appropriate regulations and procedures are applied and followed for relevant operational services. Works with regional Director and global leaders to balance alignment with local requirements and global approach.
• Works with staff to ensure client expectations are met including schedule, cost and quality of services.
• Assists direct reports in developing effective strategies for communicating with and motivating project team members.
• Intervenes and problem-solves with challenging clients as necessary.
• Provides opportunities and coaching to promote education and further direct reports’ understanding of the clinical development process including client business strategy, local regulatory and marketing requirements, and challenging financial, technical, client service and timeline issues.
• In conjunction with the global team, proposes and implements systems to support internal improvement and NAMSA’s long-term growth.
• Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
• In support of the clinical department financial goals, may assist with budget forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Participates in meetings with prospective clients.
• May present on clinical topics at regional and local conferences, seminars and NAMSA events, as needed, and supports team member involvement in these activities.
• Provides scope of project and relevant information to support the creation of proposals. Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of services to be provided by NAMSA.

Manager, Clinical Operations

Director

• Provides leadership and management direction to the Clinical Operations function.
• Build effective working relationships with both internal and external partners; may act as a Strategic Partner with key clients.
• Assists direct reports in developing effective strategies for communicating with and motivating project team members.
• Intervenes and problem-solves with challenging clients as necessary.
• Participate in resource planning to ensure project deliverables and client goals are met; ensure Associates are assigned clinical projects that are appropriate for their skills and training.
• Accomplish clinical department financial objectives by forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Confirm appropriate regulations and quality are applied within study and site management activities supported by NAMSA.
• Work with staff to ensure client expectations are met including the schedule, cost and quality of our services. May lead projects, as needed, to meet key milestones, deliverables, or organizational goals.
• Maintain qualified staff by recruiting, selecting, orienting, and training Associates and Managers.
• Provide training and development opportunities to direct staff via personal development plans, quality oversight/assurance and/or career path planning.
• May act as business owner for one or more NAMSA Clinical applications (e.g. CTMS, eTMF).
• Lead continuous process improvement initiatives to drive efficiency and innovation within the Clinical organization.
• Support review of proposals and provide input as needed.
• Participates in meetings with prospective clients.
• Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of Clinical services to be provided by NAMSA.
• May represent the company and its capabilities at professional meetings, congresses, and other industry events.
• Travel as required inside and outside of the U.S.

Senior Field Clinical Research Associate

Business System Analyst – Various Platforms

Manager, Clinical Operations

Associate Director, Global Clinical Study Management