Clinical Research Project Specialist (Renewable Contract)
- Manages study implementation from planning to closeout.
- Liaises with the sponsor and site study team during the development phase of the protocol to ensure consistency and operational viability of a protocol.
- Provides leadership in the review and development of study-related documents such as protocol, informed consent document, case report forms, source document worksheets, and CRU tools for study compliance (e.g. activity schedule and compliance checklist).
- Manages process for study specific subject safety management.
- Maintains oversight and performs checks on investigator trial master file.
- Participates in the financial tracking of study activities and monitoring of study budget.
- Responsible for the submission of all essential documents, amendments and reports to the ERB. Serves as the point of contact for all ERB related communication.
- Leads in pre study meetings between sponsor and site study team.
- Liaises with CRU operations team in logistics planning, study scheduling and training needs of site study team.
- Coordinates with sponsor, and/or monitor on the timelines for Start-Up Meeting (SUM), site training, site initiation, site monitoring and close-out visits.
- Serves as the focal point of study level communication between internal CRU team and external partners.
- Tracks study timelines and provide study updates as required.
- Identifies and communicates study status and issues that may impact on study timelines and deliverables. Escalates issues as appropriate.
- Responsible for managing study related external vendors and collaborators (e.g. obtaining quotation for services, setting up contracts and agreements and conduct kick off meetings).
Study Implementation and Close-Out
- Ensures timely reporting of all Serious Adverse Events (SAEs) to sponsor, local and global regulatory agencies as required.
- Submits study status reports and updates to the ERB in a timely manner.
- Facilitates and coordinates the resolution of any protocol issues with the site study team, sponsor and external vendors.
- Coordinates and host all monitor site visits.
- Coordinates and ensures prompt resolution of all data queries and monitoring issues.
- Escalates unresolved quality or performance issues as necessary.
- Coordinates delivery of study supplies (e.g. central laboratory kits, investigational products).
- Coordinates archival of study documentation according to requirements.
- Facilitates and collaborates with the CRU operations team in the planning, implementation and execution of studies with site study team.
- Leads in preparation and sharing of study lessons learned.
REQUIRED QUALIFICATIONS AND EXPERIENCE
- Diploma or Degree in Nursing, Science or health-related field (Health/Science/ Management).
- At least 5 years of clinical research experience.
- Experience in clinical trial study conduct processes.
- Strong working knowledge of clinical pharmacology.
- Excellent in both verbal and written communication skills.
- Excellent in organizational skills with a detailed outlook at things.
- Strong leadership and interpersonal skills.
- Highly flexible, motivated and proactive personality.
- Proficient in Microsoft Office: Word, Excel, PowerPoint, etc.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd