Job Summary:
We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Trial Associate/Sr. Clinical Trial Associate. As a Clinical Trial Associate at Scorpion Therapeutics, you will play a vital role in the planning, coordination, and execution of our early phase clinical trials, ensuring compliance with regulatory standards, study protocols, and Standard Operating Procedures (SOPs). This is an exciting opportunity to contribute to cutting-edge research and drive advancements in cancer therapeutics.
Responsibilities:
- Collaborate with the clinical trial team to develop and implement operational plans for clinical trials, adhering to Good Clinical Practice (GCP) guidelines, relevant regulations, SOPs, and study protocols.
- Assist in the development, review, and finalization of essential study documents, project plans and trackers, to ensure timely and accurate updates to cross-functional stakeholders.
- Coordinate the timely preparation, distribution, and tracking of study-related documentation and supplies, including investigational medicinal products (IMPs), to study sites.
- Maintain accurate and up-to-date trial master files (TMFs), delegation logs, internal filing systems, and electronic data capture systems, ensuring completeness and compliance with regulatory standards, including regular and documented QC reviews.
- Collaborate closely with cross-functional teams to facilitate site selection, initiation, and ongoing monitoring visits for clinical trials, ensuring adherence to study protocols, regulatory requirements, and data quality standards.
- Organize and support Investigator Meetings, study team meetings, department meetings, and training events . Assist with creation of presentations, as needed.
- Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes and distributes them in a timely fashion to stakeholders.
- May participate in review of data listings or protocol deviation reviews.
- May assist with administration of vendor invoice reconciliation, change order reviews, etc.
- Assist in managing clinical trial supplies, including drug accountability, distribution, and reconciliation.
- Assist in sample tracking, reconciliation, and query responses for samples collected from study participants (note this involves no physical handling of samples).
- Foster effective communication and collaboration with internal team members, external vendors, study sites, and key stakeholders to ensure successful execution of clinical trials. Participate in meetings with CROs and vendors.
- Assist in User Acceptance Testing for systems including but not limited to IRT and EDC.
Qualifications:
- Bachelor's or Associates degree preferred . Relevant experience may be considered in lieu of a degree.
- Experience in a healthcare or research setting is desirable.
- Familiarity with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements governing clinical trials.
- Experience managing electronic TMF including maintenance, QC, and query management related to document collection is desirable.
- Strong proficiency in MS Office, including but not limited to Outlook, Word, PowerPoint, Excel, SharePoint, and Project is required.
- Exceptional organizational skills, including the ability to manage multiple tasks and priorities concurrently within the fast-paced environment.
- Meticulous attention to detail and integrity with a commitment to accuracy and quality.
- Resourceful and proactive with strong critical thinking.
- Excellent verbal and written communication skills, with the ability to effectively collaborate with diverse stakeholders.
- Demonstrated problem-solving abilities and the capacity to work both independently and as part of a team.
- Flexibility and adaptability to thrive in a dynamic environment; good team player.
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