Clinical Research Project Specialist (Renewable Contract)

Recruit Express Pte Ltd| Date Posted: 25-May-2021
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent, Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

Study Management

  • 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.

 

REQUIRED SKILLS

  • 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)
 

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