
Apprentice Clinical Study Leader
il y a 2 semaines
Overview:
This internship is intended to provide you an elementary understanding of all areas of clinical operations, with a focus on study conduct and data collecting in prospective clinical studies. You will also be able to learn the basics of quality assurance and good clinical practice (ICH-GCP).
You will be teamed with two clinical study or clinical project leads or a quality assurance manager. They will provide you with a learning atmosphere in which you may observe their daily activities while also having the opportunity to undertake allocated duties under their supervision.
You will be able to see how our study team interacts with our external collaborators, such as PK laboratories and clinical research organizations. You will be able to become acquainted with the necessary documentation for a study as well as how a study is carried out in accordance with good clinical practice.
**Responsibilities**:
Work may entail assisting with any of the following
- Attending internal and external team meetings
- Assisting with the creation of study documentation such as protocols, informed consents, study monitoring manuals, data management guidelines, and standard operating procedures (SOPs).
- Contribute to the clinical studies' operational workflow process enhancement.
- Set up and maintain study operational trackers and training documentation
- Conducting preparation work for clinical study leads and clinical project leads such as meeting agenda set-up and distribution, meeting minutes and maintaining action item logs
- Assist with the qualification of clinical vendors and Clinial Research Organisations and contribute to the process enhancement
- Assist with the preparation of audits and inspections (if any)
Qualifications:
You are currently registered in a program professional bachelor or academic bachelor or master. You have successfully completed a minimum of 90 study credits in the respective program.
Your program is scientific or science-social based, including but not limited to biomedical sciences, pharmacology, biotechnology, chemistry, biology, psychology, social sciences, data sciences, nursing, or midwifery.
You have the ability to work effectively in a team environment, consistently maintaining a positive attitude. You have a strong desire for continuous growth and development, displaying a genuine eagerness to acquire new knowledge and skills. Strong interest and passion for the field of women's health is highly encouraged. Fluent in written and spoken English.
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