R&D Clinical Assistant

Company Name:
ACT Consulting
Hello. I have a 6+ month contract opportunity with my direct client in Parsippany, NJ that may be a fit for your background. Please take a moment to review the job description. If this is something you are interested in, please respond to me with a copy of your resume.

R&D Clinical Assistant

Length of W-2 Contract Assignment: 6+ months
Locations: Parsippany, NJ
Travel: None
Pay Rate: $35.00 maximum/Hour W-2 (Straight W-2, no relocation assistance or expense reimbursement, no benefits)
Corp-Corp Rate: No Corp-Corp, No Third Party, Client does not support H1B or EAD
Work Authorization Required: US Citizen, Green Card Holder, those Authorized to work in the US
Recruiter: John Starrs


To be responsible for routine study trail file management and day-to-day administrative aspects of allocated Global clinical trials, in support of the CPM or Senior CPM. Responsibilities will include operating to Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).

Scope / Dimensions of Roles

Support the CPM or Senior CPM by providing day-to-day administrative help for all aspects of a clinical trial
Maintain GCP-compliant study documentation and assist the COPM and/or Senior COPM with routine administrative aspects of both Healthcare clinical trials and internal study management systems.
Work as part of the overall clinical Healthcare team to deliver project requirements
Responsibilities / Accountabilities

Prepare essential clinical trial documentation; distribute, track and file documents on return
Assist with Ethics / Regulatory submissions; keep a track of submission and approvals for the study
Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems
Ensure that any clinical trial databases / tracking tools are set up and maintained throughout the trail
Set up of finance systems accurately, processing invoices and tracking payments
General study filing
Coordinate archiving of study documentation
Arrange translation of documents
Maintain supplier confidentiality and agreement files
Provide CRO contact point when CPMs out of office
Archiving of TMFs and inventory/completeness checking
Maintain PSUR stuffy tracker and answer questions from the Global Vigilance Group
Act as Clinical Trials Database administrator
Assist with the complication of Module 5 for NPD dossiers on the documentum system
Assist with providing answers to regulatory questions during dossier assessment

Key Challenges

Management of conflicting priorities within designated Healthcare projects and delivery against established timelines
Tracking of clinical trial budgets
Management of internal and external interfaces

Professional Qualifications / Experience

University degree or equivalent in life science
Knowledge of pharmaceutical industry clinical trial process and drug development
Quick to learn
Excellent organization skills
Good attention to detail and ability to work under pressure
Strong communication skills, both written and oral
Pro-active self-direction with a high level of initiative and persistence
Results-orientated, entrepreneurial and self-motivating
IT literacy; Word, Excel, PowerPoint
Strong organization and planning skills
Capable of building strong working relationships to deliver outstanding results
Knowledge of ICH GCP would be preferred

Thank you for your time.

John Starrs
Managing Partner
ACT Consulting
704-248-2949 (Office)
203-364-8432 (Office)
860-919-5301 (Mobile)
860-371-2177 (Fax)
visit ACT Consulting at www.act-info.com to view our open positions

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