If interested please reply with an updated resume in MSWord format to: ami@asterixusa.com

POSITIONS AVAILABLE IN CLINICAL RESEARCH

Clinical Research Associate

We are seeking In-House Clinical Research Associates (CRAs) for both contract and permanent positions
Description :

• Coordinate effective communication between Data Management and CRO to ensure timely design and delivery of CRFs, database(s), and the data management plan
• Develop clinical protocols, CRFs, and other documents pertinent to study conduct
• Conduct day-to-day supervision of defined aspects of the study, such as recruitment activities or randomization status
• Conduct pre-study, site selection, site initiation, interim monitoring, and study close-out visits in accordance with SOPs
• Review clinical data, generate project-management reports, and assist in the preparation of clinical study reports
• Conduct co-monitoring visits with CRO CRAs and provide written reports on monitoring and site issues

Position Requirements:

• Candidates must have a Bachelor's degree, preferably in a scientific or nursing discipline
• Must have 2 years experience in a pharmaceutical or CRO setting functioning as a CRA

Clinical Safety Associate

Description
The Clinical Safety Associate I (CSA I) is a member of the Drug Safety Department and works within a project team structure. The CSA I is primarily responsible for reviewing adverse event (SAE) reports from an assigned project(s), clinical trials (CT) and/or post marketing spontaneous reports. The CSA I is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes.

• Demonstrates basic knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Demonstrates proficiency in case triage for project molecule and serve as a back-up for additional projects.
• Identify proper case regulatory reporting requirement and seeks assistance when necessary.
• Identifies and utilizes resources and support when available for adverse event triage and management.
• Applies Good Clinical Practices document of phone, electronic, and/or fax correspondence regarding case follow-up per SOP.
• Competent and performs clinical triage per SOP.
• Identifies pertinent clinical information in Adverse Event reports and incorporates information in narrative.
• Identifies triages and /or enters relevant follow up information per SOP.
• Performs basic searches for data queries within the safety database

• Attend basic drug safety course.
• Demonstrates basic knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Demonstrates proficiency in case triage for project molecule and serve as a back-up for additional projects.
• Identify proper case regulatory reporting requirement and seeks assistance when necessary.
• Identifies and utilizes resources and support when available for adverse event triage and management.
• Applies Good Clinical Practices document of phone, electronic, and/or fax correspondence regarding case follow-up per SOP.
• RN, BSN, PA, NP, MD, MSN, Pharm D
• Clinical experience in a healthcare related field
• Previous experience in Drug Safety required
• Computer proficiency

Associate Technical Writer/Editor

Description
Produce accurate, reliable documentation for Manufacturing. Independently work with relevant departments to develop documented policies. Facilitate decisions to devise or improve business systems to produce documentation. Participate in department-wide projects to help meet company objectives. Initiate new and revised documents with appropriate justification into NovaManage and track routing to completion. Update document database and status information internally, to customers, and to key partners. Edit documents to be consistent with current formats and QA style guides. Work with stakeholders to create and meet recommended project timelines.

Requirements

• Working proficiency using MS Word 8.0, Adobe Acrobat
• Working knowledge of Electronic Document Management Systems (preferably NovaManage)
• Technical writing skills for creating/revising CGMP documents
• Working knowledge of biotechnology manufacturing processes
• Strong written and verbal communication skills
• Strong attention to detail and excellent proofreading skills
• Ability to work successfully as a team player and independently
• Ability to prioritize and organize a diverse workload to meet required timelines.
• B.A./B.S. or equivalent writing experience required. * 2-4 years technical writing experience or equivalent education required. * Experience working in an FDA-regulated industry with Manufacturing or Quality responsibilities preferred.

Nationwide - Computer System Validation Specialist

Description
Computer Validation Specialists, Technical Writers, Documentation Specialists with 21 CFR Part 11 compliance experience. Assessment of several computer systems(Manufacturing, Laboratory, network, application software). Work with system owners to explain the assessment and remediation plans. Perform gap analysis for Part 11 compliance. Perform Risk Assessment, create compliance deliverables.

Responsibilities
Knowledge of FDA cGMP and related regulations and guidelines, specific knowledge of computer validation methodologies and principles. Experience in one or more of these applications:

• EDMS (Documentum, QUMAS, Livelink)
• ERP (JDE, SAP, Ross Systems)
• Adverse Events (Argus, Oracle AERS, ARISg, Cerity)
• IND Publishing (ISIToolbox, eCTDXPress, EZSubs, CoreDossier)
• Laboratory Systems (Cyberlab, LabWare, Waters Millenium, Watson LIMS, SQL*LIMS, etc.)
• Trackwise, Maximo, Clintrial, EZsub, Plateau.

Requirements

• Experience working in FDA regulated environment is preferred.
• Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
• Excellent communication skills.
• Ability to work as a team player in a consulting environment.
• With a willingness to travel, relocation is not necessary.
• For direct and contract positions.
• Must be willing to work extended hours (overtime is paid for).
• Proficiency with MS Office tools
• Documentation management