Job Description

JOB SUMMARY
1) Assist principal investigators and other team members in the conduct and implementation of all aspects of clinical research / clinical trials.
2) Co-ordinate all activities related to clinical research / clinical trial implementation. However, procedures required in the study can only be performed in accordance to his / her qualification and licensure.
3) Mentor Junior Clinical Research Staff. Help promote a working environment of collegiality and effective teamwork.
MAIN DUTIES AND RESPONSIBILITIES
SPECIFIC * Pharmaceutical Sponsored and Investigator Initiated Clinical Trials (Operational)

• Assist and support the investigators in their clinical research activities beginning from study start-up, screening and recruiting/ enrolling patients' right up to following up the patients till the end of study. This includes:
• Reviewing of patient information sheet and consent form in accordance to protocol, institution, IRB and regulatory requirement
• Budgeting for the planned clinical trials/ clinical research
• Planning, organizing and coordinating the workflow of the clinical trials or research study.
• Investigator initiated clinical trials - submissions and reporting to DSRB and HSA, submissions and progress and final reports to grant bodies, close monitoring of budgets
• Investigator-initiated clinical trials - drugs management - labelling, accountability, disposal etc.
• Screening patients for eligibility to the study
• Explaining the study to the patient as part of the informed consent process; and
• Enrolling patients, conducting follow-up activities and ensuring the patients' compliance to the protocol.
• Ensure that the study and study procedures are conducted in accordance with the study protocol, International Conference on Harmonisation (ICH) Good Clinical Practice and TTSH and CRIO quality procedures and work instructions. These include all procedures required in the screening and follow-up activities.
• Drawing blood from study participants (venepuncture), handling and processing blood samples, handling laboratory samples (eg blood, tissues, urine and stool), recording ECG, and monitoring vital signs.
• Maintain accurate and complete documentation / records of study assigned. Plan, organize and maintain Investigator files.
• Ensure proper storage, documentation and dispensing of investigational product (device, drugs and pharmaceuticals). Plan, organise and maintain accountability of drugs records i.e. Receipt, storage, dispensing, returning and destroying. Ensure drugs are labelled in accordance to Good Clinical Practice Guidelines and the local regulations.
• Process, label, store specimens and prepare for dispatch in accordance with the requirements of the research protocol. Maintain the completion and chain-of-custody of the specimen log.
• Tracing of laboratory and diagnostic reports. Able to recognize abnormalities and escalate to investigator.
• Assist Manager or designate in doing budgeting for the projects that they are handling.
• Ensure that the project timelines are maintained. These include timelines for serious adverse events (SAEs) reporting (24 hours upon awareness), Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) reporting, case report form completion and data clarification.
• Attend and represent the institution in the Investigator's Meeting (local / overseas), site initiation meeting, periodic meetings and close-out meetings as and when required.
• Liaise with relevant internal and external agencies during the course of work
• Ensure the safety of clinical research subjects and report any serious adverse events to the investigators, hospital, sponsors and regulatory authorities accordingly.
• Ensure that investigators review all safety and UPIRTSO reports promptly.

Ensure that the appropriate reports are sent to DSRB promptly within the stipulated timelines. * Follow-up on those patients experiencing adverse event or serious adverse event and ensure prompt reporting

• Update subject visits tracker promptly, ensure and facilitate prompt and accurate billing to sponsors
• Monitor the financial aspects of the assigned study and advise the investigator and CRU accordingly
• Ensure timely submission of progress report to the relevant agencies and authorities
• Ensure timely renewal of IRB approvals and time extension requests for grants
• Maintain data and provide study reports.
• Ensure proper archiving of medical records and study documents at study end
• Communication
• Provide information to and educate research subjects
• Maintain and establish good relationships with sponsor, clinicians, other support staff and subjects
• Good listening and communication skills to educate research subjects
• Address subject's concerns and questions via phone calls or in-clinic visits
• Keep PI up-to-date on project progress and significant updates.
• Strategic
• Research for information to add value to relevant projects
• Proactively pre-empt potential obstacles
• Provide solutions to problems within timelines
• Be a facilitator and mentor to junior CRC

GENERAL
1. To undertake any task assigned by the Supervisor / Manager / Head of Department
2. Participate in the Hospital's / Department's quality improvement activities and participate in Joint Commission International (JCI) Accreditation or other forms of accreditation or audits as required.
3. Actively engage in service innovation and quality initiatives within the department
JOB REQUIREMENTS
EDUCATION
Preferably State Registered Nurse or Relevant degree in Sciences or Nursing.
PROFESSIONAL LICENCE
Registration with Nursing Board, Singapore (Applicable to State Registered Nurse only).
TRAINING * Basic Computer Skills.

• Trained in ICH Good Clinical Practice.
• Trained in venepuncture, vital signs assessment and ECG recording.
• Effective communication skills.
• Trained in International Air Transport Association (IATA) Dangerous Goods Regulations.
• Trained in CPR, AED or BCLS or equivalent.

EXPERIENCE
Have a keen interest in research. At least 2 years experience in conducting trials. Self motivated and pro-active attitude. Have strong organizational and communication skill.

Skills Required