该职位来源于猎聘 Education and Work Experience:
- Bachelor's Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science
- Minimum of 2 years experience as a Clinical Research Associate Knowledge, Skills, and Abilities:
- Excellent verbal and written communication skills
- Good verbal and written English language skills
- Strong computer literacy e.g. MS word, Excel, PowerPoint, internet
- Excellent organizational, record retention, and time management skills
- Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements Duties and Responsibilities (including but not limited to):
- Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
- Conduct study feasibility and site selection activities
- Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
- Assist with investigator meeting activities including organization, preparation and attendance
- Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
- Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
- Establish and maintain good rapport with study sites.
- Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
- Representation of CRAs during an audit or inspection when assigned
- Coordinate timely shipment of clinical supplies and study drug to sites.
- Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
- Maintain adequate site tracking records
- Follow up of drug safety issues and safety reports in timely manner, if applicable
- Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
- Develop and implementation of corrective actions when appropriate
- Assist with data query form (incl. query process)
- Prepare /review all patients tracking records
- Input and maintain study information concerning subject status of financial reimbursement to sites.
- Conduct and assist with administrative activities as a member of the project team.