JOB DESCRIPTION:
 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 challenges the adequacy of planning for study implementation
 In collaboration with the project physician, directs 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)
 Collaborates and supports operational activities as need be.
 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
JOB REQUIREMENTS:
Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent
 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)
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