To conduct medical research for clinical trial feasibility assessments and proposals based on Request for Proposals (RFPs).
To conduct medical research as requested by Novella Clinical Sr. Management.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Primarily supports the proposals, bid defense, study start-up processes. In secondary roles, supports medical writing assignment needs, and marketing needs in the research, review, and generation of marketing materials.
· Plans, organizes, and conducts research assignments to increase scientific knowledge on medical-related topics. It is expected that these research efforts contribute positively toward fostering internal knowledge with regard to a sponsor’s investigational product, as well as externally validating Novella Clinical’ s capabilities and strategies to the sponsor.
· Researches and communicates pertinent scientific/clinical information regarding clinical trials that Novella Clinical is requested to conduct feasibility on, or bid on in proposal form.
· Researches information and materials needed for the Study Start-up, such as the identification and verification of potential sites for clinical trials, and Clinical Project Management groups.
· Investigates the clinical subject area provided in the sponsor’s RFP in order to define the scope of the clinical trial; Researches pertinent scientific/clinical information that may include, but is not limited to: disease background (etiology, epidemiology, statistical information, symptoms, and methods of diagnosis), current standards of care (treatments methods), how the sponsor-proposed intervention fits into the current treatment landscape, and information regarding competing therapeutics in clinical development. This information is augmented with a critical evaluation of the clinical trial protocol and supporting documents, so as to proactively identify study strengths and potential pitfalls.
· Identifies, analyzes, and describes the competing clinical trial landscape in order to assist in assessing trial feasibility; draws conclusions and makes recommendations in text document (with supporting graphs, maps, and references) to be included in the feasibility report or therapeutic background section of the proposal. Additionally, findings are communicated in strategy meetings with management and are often included in bid defense presentations.
· Identifies and presents the afore mentioned research materials to assist in determining country selection and other undefined specifications for clinical trials in the absence of sponsor input, or at the request of the sponsor.
· Maintains detailed records of work and creates and maintains internal libraries and databases, while also remaining informed of current scientific and clinical research being conducted.
· Works closely with members of management team and client to negotiate scope of work to be performed for a project.
· Performs other duties as assigned.
KNOWLEDGE, SKILLS, AND ABILITIES:
· Thorough knowledge of appropriate open source and proprietary resources to conduct research.
· Ability to maintain long-range projects while managing daily details with a high degree of accuracy.
· Excellent communications skills (verbal and written).
· Strong organizational and interpersonal skills.
· Ability to work flexible hours.
· Demonstrated ability to perform multiple tasks effectively.
· Ability to interact with all levels of staff to coordinate and execute proposal activities.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
· Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
· PhD in a scientific field (or comparable advanced scientific/clinical degree, such as PharmD) and 1 - 2 years of direct experience in technical writing.
· Demonstrated ability to work effectively at all levels of an organization.
· Excellent written and verbal communication skills. Prior experience in publishing peer-reviewed publications and giving scientific/clinical research presentations.
· Ability to work independently, prioritize and work in a team environment is essential.
· Working knowledge of MS Word, Excel, and Publisher required.