Study Start-up Associate
6 days ago
About Us:
The Grand Pacific CRO team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on meeting customers where they are and providing exactly what they need to move their products forward.
Job Summary:
To coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials, across designated Grand Pacific CRO projects and clinical trials, in relation to start-up activities.
**Responsibilities**:
- Support regulatory activities during the start-up phase of clinical trials.
- Preparation of documents for submission to Ethics Committees (EC)
- Prepare and adapt Patient Informed Consent form with country/site Specifications and according to Regulatory and EC requirements.
- Support budget adoption to country and site requirements.
- Collect documents required for submission and support of the process until ethics vote/ approval or feedback is given, EC communication in close collaboration with Clinical Operations Team
- Initiate language translation of documents as applicable (e.g., Patient Informed Consent); review and adapt translations in an appropriate way.
Delivery:
- Accountable for preparation, negotiation and signature confirmation on clinical contracts (including budgets) and amendments.
Qualifications:
- Degree or a combination of education, training and relevant industry experience
Technical Knowledge & Skills or other requirements:
- Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
- Strong written and verbal communication skills
- Effective time management and organizational skills
- Attention to detail and accuracy in work.
- Ability to work independently and ability to adapt to changing priorities.
- Ability to establish and maintain effective working relationships with co-workers, managers, sponsors and investigators.
Work Experience:
- Previous clinical research exposure is preferred.
- Minimum 3 years’ experience in administrative support role
- Awareness and knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines preferred.
- Knowledge of applicable protocol requirements as provided in company training.
Job Measurement:
- Meeting ethics submission deadlines with all required completed documents.
- Successful assistance through preparation, handling, distribution and archiving of documents.
- Effective organization of expense claims, travel arrangements, study-specific equipment and budget activities
- Development of new ideas and processes
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