
Study Operations Manager
1 week ago
This Study Operations Manager position is crucial in ensuring the success of clinical studies. Key responsibilities include preparing study documents, submitting them to the Ethics Review Committee, recruiting and coordinating research participants, and managing all study-related documents.
Main Objectives:- Recruit and coordinate research participants, ensuring their comfort and accommodation throughout the study.
- Develop a comprehensive understanding of the protocol, including study procedures, timelines, inclusion and exclusion criteria, and confidentiality requirements.
- Attend investigator meetings as required or requested by the Principal Investigator (PI).
- Translate study documents as needed, demonstrating strong language skills.
- Serve as a liaison with the Ethics Research Committee (ERC), preparing and submitting study documents, such as progress reports, for review and approval.
- Prepare various study materials, including informed consent documents, case report forms (CRFs), and other data collection tools, as requested by the PI.
- Maintain organized study files, encompassing regulatory binders, study-specific source documentation, and other essential materials.
- Assist in the preparation of all documents related to the informed consent process, ensuring compliance with relevant regulations and policies.
- Conduct the informed consent process with research participants, addressing any questions or concerns, and obtaining necessary signatures and dates on relevant forms.
- Screen potential participants for eligibility based on protocol-specific inclusion and exclusion criteria, documenting each individual's status.
- Coordinate participant tests and procedures, ensuring timely completion and accurate data collection.
- Maintain an adequate inventory of study supplies, as deemed necessary by the study team.
- Complete study documentation and maintain accurate records, adhering to ERC requirements and established procedures.
- Foster effective communication with research participants and the PI throughout the study, addressing any concerns or issues that arise.
- Collaborate with the PI to manage day-to-day study activities, including problem-solving, communication, and protocol management.
- Manage study data, completing data entry accurately and efficiently.
- Participate in qualitative research, which involves coordinating interviews and focus groups, conducting interviews and focus groups, facilitating and observing focus groups, taking notes, transcribing audio data files, and contributing to data analysis.
- Perform additional tasks as requested by the Head of Unit, demonstrating flexibility and adaptability.
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