Clinical Trial Specialist
Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.
Responsibilities will include, but are not limited to, the following:
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.
- Attends internal team and other meetings as required.
- Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
- Creates and reviews site feasibility assessments required for study participation.
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
- Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate
- Prepares metrics and updates to key deliverables for management.
- Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
- Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
- Participates in the development, review and implementation of departmental SOPs and processes.
- Bachelor’s degree in nursing, science or health related field required with at least five or more years of related experience. At least two years of clinical trial experience
- Ability to manage time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail required
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
To apply please send CV and letter of interest to firstname.lastname@example.org