Real Staffing
Clinical Research Scientist
Real Staffing, Summit, New Jersey, us, 07902
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.Job Description
Responsibilities will include, but are not limited to, the following:Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).Clinical study report preparation.Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.Participate in Development Planning for assigned compounds.Oversee and challenge the adequacy of planning for study implementation.In collaboration with the project physician, direct the planning and implementation of clinical programs to meet corporate and clinical research goals.Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety).Collaborate and support operational activities as needed.Assist in establishing project budgets.Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.Participate and present at investigator meetings.Participate in adhoc meetings (e.g. marketing).Assist in document template design and SOP writing.Participate on various corporate committees.Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required.Lead team meetings as required.Qualifications
Prerequisite:Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field).Skills/Knowledge Required:Minimum 2 yrs. experience in medical or technical writing.Clinical monitoring experience preferred.Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.Extensive medical/scientific and clinical research knowledge.Knowledge of Medical Terminology.Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics.Proficient at data interpretation.Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions.Experience in all aspects of the drug development process.Knowledge of GCP and ICH Guidelines.Experience in presenting at Investigator Meetings.Detail-oriented, well-organized.Limited travel required.Ability to assimilate technical and scientific information quickly.Clinical project management skills.Proficient in Microsoft Word, Excel, PowerPoint; Microsoft Project a plus.Demonstrated ability to work as part of a team.High level of interpersonal and communication skills (written and verbal).Additional Information
All your information will be kept confidential according to EEO guidelines.
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Responsibilities will include, but are not limited to, the following:Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).Clinical study report preparation.Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.Participate in Development Planning for assigned compounds.Oversee and challenge the adequacy of planning for study implementation.In collaboration with the project physician, direct the planning and implementation of clinical programs to meet corporate and clinical research goals.Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety).Collaborate and support operational activities as needed.Assist in establishing project budgets.Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.Participate and present at investigator meetings.Participate in adhoc meetings (e.g. marketing).Assist in document template design and SOP writing.Participate on various corporate committees.Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required.Lead team meetings as required.Qualifications
Prerequisite:Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field).Skills/Knowledge Required:Minimum 2 yrs. experience in medical or technical writing.Clinical monitoring experience preferred.Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.Extensive medical/scientific and clinical research knowledge.Knowledge of Medical Terminology.Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics.Proficient at data interpretation.Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions.Experience in all aspects of the drug development process.Knowledge of GCP and ICH Guidelines.Experience in presenting at Investigator Meetings.Detail-oriented, well-organized.Limited travel required.Ability to assimilate technical and scientific information quickly.Clinical project management skills.Proficient in Microsoft Word, Excel, PowerPoint; Microsoft Project a plus.Demonstrated ability to work as part of a team.High level of interpersonal and communication skills (written and verbal).Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr