Executive, Clinical Research & Innovation Office (1-year contract)

JOB SUMMARY

The CTU project executive will assist the CTU manager to oversee and manage the execution of clinical research studies supported by CRIO. This role involves coordinating with cross-functional teams and stakeholders to ensure the successful implementation of clinical studies, ensuring compliance with regulatory requirements, and facilitating smooth implementation of clinical research studies. The candidate should possess a good understanding of clinical research, excellent organisational skills and thus be able to manage multiple projects simultaneously.

MAIN DUTIES AND RESPONSIBILITIES

A) Project Planning and Execution

1. Develop and implement project plans for clinical research studies, ensuring alignment to study protocols, timelines and objectives.
2. Coordinates the procurement of research-related equipment or purchases.
3. Monitor study progress, identify potential risks and implement corrective actions to ensure timely completion.
4. Coordinate with investigators, the assigned study team and sponsors/collaborators to ensure smooth execution of clinical trials.
5. Coordinates and/or attends project-related meetings that may be required, including providing study progress updates from TTSH, managing the minutes of meetings, circulation to stakeholders and overseeing the resolution of action items.
6. Assists the investigator with the generation of necessary reports e.g. for funding agencies, finance department and grantor/collaborator as required of the clinical research studies.
7. Monitor project progress, identify risks (timelines, budgets, quality) and implement mitigation strategies to ensure successful completion of studies. (JG12)

B) Regulatory Compliance

1. Ensure all clinical research activities comply with applicable regulatory requirements.
2. Works with the study team to ensure that the relevant ethics and regulatory applications are maintained for the duration of the studies.
3. Ensure the maintenance of audit-ready documentation, including protocols, informed consent forms and case report forms.

C) Coordination and Communication

1. Acts as the primary point of contact for investigators, sponsors/collaborators, and internal study team members.
2. Facilitate regular meetings with stakeholders to review trial progress, address challenges and ensure alignment.
3. Coordinate with vendors and internal hospital departments as required of the study to ensure seamless trial operations.
4. Assist PI to prepare study dates for study-related meetings.

D) Management of Study Budgets and Study Billings

1. Ensures study budgets are developed and approved by the Sponsor/Collaborator for industry-sponsored studies and PI approval of a budget for CTU-provisioned services of grant/collaborator-funded investigator-initiated studies.
2. Monitor utilization of funding for investigator-initiated studies to ensure that study billings/claims are performed regularly and within the claims period for grant-funded/collaborator- funded investigator-initiated studies.
3. Ensure that study billing for industry-sponsored studies is invoiced according to the study agreement.
4. Works with both internal and external stakeholders to facilitate the necessary claims and/or study billings in a timely manner.

E) Study Training Oversight

1. Ensure that study team members have relevant research-related trainings for the purpose of conducting clinical research studies e.g. CITI, GCP, HBR etc.
2. Ensure that study team members are trained on latest approved study protocol and manuals as required.

Job Requirement: 

• At least a Bachelor’s degree in relevant disciplines, such as Nursing, Pharmacy, Sciences or Medicine
• Proficient in MS office applications – Word, Excel, PowerPoint and other project management tools
• Have strong project management skills with ability to manage multiple studies simultaneously
• Have good problem-solving skills.