Clinical Research Coordinator

3 years exp **Roles & Responsibilities** **JOB PURPOSE** Engage in company training program to gain knowledge and skills required to independently assist investigators in conducting clinical trials in accordance with study protocol, standard operating procedures (SOP), Good Clinical Practice (GCP), and applicable regulatory requirements. Interested to grow as a Clinical Trial Assistant (CTA) and have a chance to be groomed towards a Clinical Research Associate (CRA). **RESPONSIBILITIES** **Clinical Trial Management** - Under close supervision, clinically and administratively manage clinicalstudies. - Complete appropriate therapeutic, protocol and clinical research training to perform job duties. - Gain experience in study procedures by working with experienced clinical staff in Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance. - Provide support to Project Managers, CTL and or CRAs on administrative and/or project specific tasks. - Attend study initiation visit, close-up meeting, investigator meeting and other study-related meetings. - Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, screening, recruitment and enrolment, Case Report Form (CRF) completion and submission, and resolve data query. - Under close supervision, proper collecting, processing, labelling and shipping biological samples to relevant laboratory as per laboratory manual and study protocol. - Ensure proper maintenance of study-related documents filing. - Under close supervision, track study-related reports and report of abnormal findings to investigators, as necessary. - Under close supervision, assist investigators in adverse events/ serious adverse events reporting. - Under close supervision, ensure study materials such as device and drug are stored as accordance to protocol and limited access. - Under close supervision, track and submit study-related financial payments. - Under close supervision, to set up, organize and maintain clinical study documentation (e.g. Trial Master Files, etc.) including preparation for internal/external audits, final reconciliation and archival. - Under close supervision, to coordinate ordering/dispatching, tracking of trial materials (e.g. diary cards, lab supplies, drug supplies, etc.) as appropriate. - Under close supervision, to coordinate document translation, if required. - Under close supervision, to assist in the tracking and distribution of safety reports. - To assist CRA/CTL with study specific documentations and guidelines as appropriate. - To attend project team meetings and generate meeting minutes. - To assist with Investigator Meeting coordination, activities preparations and generate meeting minutes. - Return all study materials to sponsor upon study completion. - Destruct study drug as per site’s policy or sponsor’s SOP. **Subject management** - Ensure proper documentations and verification of informed consent process. - Under close supervision, perform screening/pre-screening as per study protocol. - Under close supervision, dispense study drug and maintain drug accountability as perstudy protocol and GCP. - Under close supervision, perform venepuncture or cannulation as per study protocol. - Protect the rights, safety, and well-being of patients enrolled in clinical trials. **REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**: - Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines - Computer skills including proficiency in use of Microsoft Word, Excel and use of a laptop computer - Strong written and verbal communication skills including good command of Englishlanguage - Excellent organizational and problem-solving skills - Effective time management skills - Ability to manage competing priorities - Ability to establish and maintain effective working relationships with co-workers, managers and clients **MINIMUM REQUIRED EDUCATION AND EXPERIENCE** Degree or currently enrolled in bachelor's degree program in health care or other related discipline.; or equivalent combination of education, training, and experience **PHYSICAL REQUIREMENTS**: - Extensive use of telephone and face-to-face communication requiring accurate perception of speech - Frequent travel to sites, primarily domestic, may include international travel UniQ Search Asia is a leading recruitment services provider based in Singapore. Our consultants are essentially apt in executive search and recruitment skills coupled with regional experience across Asia. Looking for the right talent has never been easier. As our motto says "UniQ is all you need", we are committed to providing the best of services and expertise to your recruitment needs. Specializing i