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CURRENT OPENINGS (Check Back Frequently!)
Project Management / Project
Coordination / Data Management
Job
Description:
Coordinate and manage activities and resources in support of the project
team for multiple projects simultaneously. Interact with internal
departments including operations, data management, and clinical to execute
daily tasks associated with providing clinical data monitoring and
management to sponsored pharmaceutical clinical research trials.
Required Experience, Knowledge, Skills:
Minimum of a 4 year Bachelor's degree. Life sciences or related field a
plus.
Minimum 1-3 years' experience in clinical research and clinical trial
coordination/management.
Experience in central nervous system (CNS) trials a plus.
Bilingual a plus.
Working knowledge of GCP and CFR's relating to clinical research and data
systems.
Strong interpersonal skills with ability to interact with all levels of
personnel in a professional manner.
Excellent organization, attention to detail, time management and problem
solving skills.
Knowledge of or ability to understand, the client needs and project
objectives.
Computer proficiency including excellent skills in Windows with Microsoft
Office system and applications, specifically, Excel, PowerPoint, Outlook and
Word. Experience with Sharepoint a plus.
Comfortable and experienced managing daily project workflow through online
automated systems.
Opportunity to work from home as well as from the office. Ability to work
independently.
Tasks/Responsibilities:
Support the project team during study start-up, maintenance and close-out
phases.
Execute and test data transfers to ensure internal and sponsor technical
requirements are met.
Responsible for managing day-to-day operations and communication with
research sites, sponsor, and study contacts. Identify and effectively
communicate inquiries or issues appropriately utilizing escalation plans for
communication as necessary.
Work with local site and sponsor teams globally to initiate and facilitate
communication between CROnos Clinical Specialists and site raters. Navigate
complexity and logistics of global working teams.
Prepare client data so as to facilitate clinical analysis in the timelines
specified.
Organize, attend and participate in internal team meetings as well as
external meetings with sponsors.
Prepare and/or edit meeting minutes, presentations, and tables.
Maintain and contribute to team collaboration workspaces.
Alert appropriate team members of potential timing and resource issues.
Support Operations and Clinical to develop workflow processes including
related training materials.
Track and store all study correspondence and materials according to
company guidelines and SOPs.
Support QA activities during internal and external client audits.
Test project specific systems, user acceptance testing.
Document and train on unique project computer systems; develop internal
training materials and conduct internal training.
(Apply Now!)
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Clinical Specialist
Job Description:
A Clinical Specialist, in collaboration with the Clinical Director
and the Clinical Lead, will perform remediation activities with site
raters, in relation to ongoing clinical trials. The Clinical
Specialist may also assist in the organization and completion of
didactic training slide sets, documents and other presentations for
the rater audience as well as project sponsors. Other Clinical
Specialist responsibilities may include: perform basic and in depth
research on disease states and ratings scales, data monitoring,
rater monitoring, functional assessments of rater performance and
qualification, assist in preparing and disseminating rater
communications, provide feedback and review of sponsor reports, and
contact with sponsors or other outside scale experts.
Required Experience, Knowledge, Skills:
Minimum of a Masters degree (MA/MS) in Psychology, Counseling,
Psychiatric Nursing or Social Work.
Minimum of 3 years experience administering psychiatric
assessments, ratings scales and/or Structured Clinical Interviews.
Minimum of 3 years clinical experience with related psychiatric
populations (psychosis and depression required)
Bilingual a plus.
Experience in central nervous system (CNS) trials a plus.
Strong interpersonal skills with ability to interact with all
levels of personnel and clientele in a professional manner.
Excellent organization, attention to detail, time management and
problem solving skills.
Knowledge of or ability to understand, the client needs and
project objectives.
Computer proficiency including excellent skills in Windows with
Microsoft Office system and applications, specifically, Excel,
PowerPoint, Outlook and Word. Experience with SharePoint
applications a plus.
Opportunity to work from home as well as from the office.
Tasks/Responsibilities:
Participate in all orientation, training and calibration
activities as required.
Provide independent clinical analysis of case data and remedial
action preparation.
Complete case discussions as scheduled.
Responsible for completion and timely submission of case detail
and outcome reports.
Participate and assist with the research, preparation and
presentation of sponsor meetings and reports.
Organize, attend and participate in internal team meetings.
Prepare and/or edit meeting minutes, presentations and tables.
Research and prepare training material, original publications/
posters and didactic presentations.
Provide comprehensive review of rater data submitted from assigned
studies.
Monitor and report on rater progress throughout study lifetime.
Track and report all task progress and time on task.
Willingness to collaborate with other departments on various
administrative tasks and projects.
Responsible for appropriate time management including prompt
completion and submission of individual project duties.
Support Quality Assurance during external client audits.
Responsible for any other duties delegated by the immediate
manager or department lead.
(Apply Now!)
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