|Reference # : ||18-14623
||Title : ||Job opening for Clinical Scientist in Lawrenceville, NJ|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||03/26/2018 / 09/25/2018
| Description |
|Job Title: Clinical Scientist|
Location: Lawrenceville, NJ, 08648
Duration: 6 Months
Job ID: 22815-1
Job Description and Responsibilities:
- Management of the operational components of clinical trials for Phase I-II a studies in support of global regulatory filings including IND, NDA, MAA, and life-cycle management programs.
- Co-author complex protocols with minimal direction.
- Interpret relevance of review comments and incorporate as appropriate.
- Ensure protocol specific content and Client's required sections are included in the Informed Consent Form.
- Interact with and manage stakeholder expectations, with functional groups outside of Exploratory Clinical and Translational Research, to facilitate the successful development and implementation of assigned studies.
- Operationalize multiple protocols within and/or across program(s), therapeutic area(s), and/ or site(s) using project management tools.
- Proactively identify potential risks that could impact project performance and/ or outcome and develop contingency plans and necessary actions to prevent or address problems regarding timelines, budget, resources, and quality.
- Co-author and/or provide input into key study documents such as protocols and clinical study reports and participate in the development of rationale, objectives and protocol design to ensure consistency within program(s).
- Drive and provide leadership for the development of study related documents with the input from team members: [e.g. operational components of the protocol (site monitoring plan, risk management plan, CRF instructions, study tools, informed consent, etc)].
- Successfully drive the operational components of study including site feasibility and selection, site initiation activities, site start-up, and patient recruitment and preparation and/or review of appropriate clinical and regulatory documents.
- Review and provide input on CRF development and data review and analysis plan to ensure that all protocol required data points are captured.
- Lead process improvement teams and initiatives.
Interested candidates can send their updated resumes on email@example.com and you can also reach me at 973-967-3431.
- Equivalent of Bachelor's degree (or RN) and 5+ years related experience, OR Master's degree and 4+ years related experience, OR PharmD/PhD degree with 3+ years clinically related experience.
- Strong understanding of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines.
- Knowledge of clinical research (Phase I-IV processes, procedures, and timelines).
- Experience conducting Phase I clinical trials required.
- Strong project management experience and ability to apply aspects at the protocol and program level.
- Understanding of data management and statistical analysis process.
- Thorough understanding of clinical pharmacology concepts and scientific principles.
- Experience delivering projects with exemplary accuracy and attention to detail with the ability to work independently.