The biggest opportunity in the first research organization by Thai startups. Clinixir looking for outstanding candidates to be a part in building and driving CRO to grow globally.
Responsibilities:
- Tracks the progress of study start up activities, proactively identifies issues, and proposes solutions to keep study on track.
- Provides information to Project Lead to ensure that all study tasks are delivered on time within budget and with the desired quality
- Accurately tracks project start up action items from inception through completion and proposes corrective action plans
- Provides overall study support to functional leads to ensure the successful completion of project deliverables
- Clearly and effectively communicates with sites and/or sponsors as needed
- Tracks all study related communications, and proposes communication tools as needed
- Develops metrics and dashboards to interact with project team to keep study on track
- Reviews and/or proofreads documents, reports, and other correspondence prior to submission to the Sponsor and project team
- Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/CTL. Reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.
- Local Site ID and Feasibility Support - Works with the Project Lead and Clinical Team Leader to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution.
- Provides technical support to the project team in the creation, formatting and maintenance of study documents using Microsoft Office applications
- Serve as the primary point of contact for the Project Leader (or designee) during start up on allocated projects
- Performs all assigned activities within the country that leads to start-up of investigative sites
- Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Provides country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated staff responsible for data protection at the country, provides clear data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template.
- Support for the creation of internal training materials for local legislative requirements. Provides input to the team to assist with EC or CA issue resolution at the country level.
- Assists Project Lead (or SSU Lead) in the development of trial tools or Documents
- Support business development by providing input of country regulation/or local regulatory authority requirements.
Qualifications:
- Bachelor's degree in pharmacy, nurse, clinical sciences or health-related field required.
- Excellent verbal, interpersonal, and written communication skills in both local and English language.
- Strong grasp knowledge of local regulatory requirements/guidelines including ICH-GCP, clinical development and clinical research knowledge will be an advantage.
- 6 months - 2 years experience in clinical start-up activities/clinical research is preferred or equivalent work experience required.
Good Benefit
- Annual Leave 15 Days
- Birthday leave 1 Day
- Medical Insurance
-Provident Fund
-Annual health check with flu vaccination
Clinixir Office, 173/18 Asia Centre Building (BTS Chongnonsi)
