Clinical Scientist

Integrated Resources, Inc

Collegeville, Pennsylvania

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Analysis Skills, Assays, Biotech and Pharmaceutical, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Contract Research Organization (CRO), Corrective Action, Cross-Functional, Data Analysis, Documentation, GCP (Good Clinical Practices), Health Science, Identify Issues, Information Technology & Information Systems, Maintain Compliance, Medical Writing, Microsoft Excel, Microsoft Word, Pediatrics, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Manufacturing, Project/Program Coordination, Protocol Design, Publications, Regulations, Regulatory Submissions, Rehabilitation Nursing, Staff Training, Statistics, Strategic Planning, Team Lead/Manager, Team Player, Time Management

LOCATION

Collegeville, Pennsylvania

POSTED

2 days ago

Clinical ScientistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job Description• The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program.• coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays.• protocol and study training• Data review and interpretation• study and/or program scientific and integrity oversight• safety review and communication• regulatory document, study report and publication preparation and review• Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician• Support the preparation of other clinical documents as required• DATA REVIEW AND INTERPRETATION:o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverableso Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegatedo Study analysis and decision point preparationo Interprets data and is able to identify issues of moderate/difficult complexityo Conducts data review independently• STUDY MEDICAL OVERSIGHT:o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study• SAFETY:o Ensure timely communication of safety issueso Review and approval of subject narratives as delegated by the Lead Clinician• REGULATORY AND PUBLICATIONS:o Provide input, review and edit clinical study reports (CSR)o Provide full review of content and integrates information from literature and other sources as appropriateo Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)o Audit responses as delegated by the Lead Clinician• CLINICAL PROGRAM IMPLEMENTATION:o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issueso Initiate and coordinate corrective action for major medical/safety/scientific study level issueso Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolvedo Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the teamo Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelineso Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staffo In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are meto Ensure standard processes, tools, and procedures used consistently and globallyo Participates in developing training strategy for study with the study team membersProvide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team memberso Ensures appropriate filing of documentation in the trial master fileQualificationsQUALIFICATIONS AND SKILLS NEEDED:• M.D., PhD, Pharm. D. Degree in science or health-related field preferred, will consider highly motivated and experienced MA or MS• 10+ years of pharmaceutical/CRO experience preferredTECHNICAL SKILLS:• Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field• Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents• Has independently authored clinical study documents• Has experience with participating in and informally leading an operational team• Applies knowledge of internal/external business challenges to facilitate process improvements• Has ability to proactively resolve issues and work independently with minimal supervision• Has working knowledge of statistics, data analysis, and data interpretation• Has exceptional written and oral communication and cross-functional collaborative skills• Is proficient in MS Word, Excel, and PowerPointJob LocationI'm interested

About the Company

Integrated Resources, Inc

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