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 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, drugsafety)
- 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

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 GCPand 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

Qualifications
Prerequisites:
- 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