Description
Responsibilities- In conjunction with Associate Director, coordinate activities of clinical trial sites.
- Attend Site Qualification Visits to assess investigator's staff and facilities.
- Contribute to study design and initiate planning for global programs (Protocol Amendments and ICF template revisions; Case Report form design and review; Patient instruction cards, and other study materials).
- Assist in the preparation and review of supportive study documents and study plans (Monitoring Plan, Lab Manuals, Project Plans, IWRS, CRF Guidelines).
- Ensure all local regulatory approvals are in place for conduct of trial.
- Conduct study initiation visits, including training of on-site personnel in all aspects of study requirements.
- Conduct monitoring visits to the sites at intervals specified in monitoring plan.
- Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate.
- Identify, assess and implement appropriate activities to ensure trial progress.
- Coordinate supplies for specimen collection and shipment of samples for assays.
- Monitor supply of investigational and comparator drug supply throughout the trial.
- Assist with product accountability at site and take appropriate action to resolve discrepancies.
- Report adverse events per protocol and Standard Operating Procedures.
- Conduct study close-out visits.
- Document all trial information with adherence to applicable guidelines and Standard Operating Procedures.
- Remain current with study data.
- Maintain high level of familiarity with clinical literature of study area.
Position Requirements
- BA/BS in Life Science or related discipline.
- 2-5 years of experience in clinical study coordination.
- Preferred knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
- Ability to work within a team.
- Excellent communication and interpersonal skills.
- Attention to detail and highly organized.
- 20% travel.