Jasper is a biotechnology company focused on developing new therapies to treat both chronic and life-threatening diseases.
Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision. This position will be a hybrid role requiring 2-3 days in the office.
Position Summary:
Reporting to the Director of Clinical Operations, the Senior Clinical Trial Associate (Sr. CTA) plays a crucial role in supporting the planning, execution, and management of clinical trials within a small biotech company. The Sr. CTA works closely with the clinical operations team to ensure the successful implementation of clinical trials, adherence to regulatory guidelines, and the collection of high-quality data. This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment.
Responsibilities:
- Trial Preparation: - Assist in the development of trial-related documents, including protocols, informed consent forms, case report forms, and study manuals. - Coordinate with cross-functional teams to ensure timely availability of trial supplies, investigational products, and study materials. - Assist in the selection and qualification of investigational sites, including site initiation visits and training
- Trial Execution: - Support the implementation and management of clinical trials according to study protocols, standard operating procedures (SOPs), and regulatory requirements. - Assist in the coordination of site initiation, monitoring, and closeout visits, ensuring compliance with study timelines and deliverables. - Track and manage study-related documentation, including regulatory submissions, ethics committee approvals, and site contracts. - Collaborate with study sites to ensure accurate and timely collection of study data, including source document verification and query resolution. - Assist in the management of trial budgets, including tracking expenses and processing payments to sites and vendors
- Data Management and Quality Control: - Perform data entry and data cleaning activities, ensuring accuracy and completeness of study data. - Assist in the review and reconciliation of clinical trial data, identifying and resolving discrepancies. - Contribute to the development and maintenance of data management plans and data validation procedures. - Participate in quality control activities, including internal audits and inspections, to ensure compliance with regulatory standards
- Regulatory Compliance: - Stay updated on relevant regulations, guidelines, and industry best practices related to clinical trial conduct. - Assist in the preparation and submission of regulatory documents, such as clinical trial applications and safety reports. - Support the maintenance of trial master files, ensuring completeness and accuracy of essential documents
Qualifications and Experience:
- Bachelor's degree in a scientific or healthcare-related field
- 2-3 years prior experience in clinical research, preferably as a Clinical Trial Associate. Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Familiarity with clinical trial protocols, informed consent processes, and data collection methods. - Strong organizational skills and attention to detail
- Excellent written and verbal communication skills
- Proficiency in using clinical trial management systems and electronic data capture systems
- Ability to work independently and collaboratively in a team environment
Other Knowledge and Skills;
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Exhibit an entrepreneurial spirit with “can-do” approach
- Assist and manage the review of Clinical Development operating procedures and oversee changes to processes and/or implementation of new processes
- Ability to effectively communicate and exhibit exceptional interpersonal skills; strong team player
- Excitement about the vision and mission of Jasper
What We Offer;
- A growing company focused on advanced, transformational scientific research aiming to cure multiple, life-threatening and devastating diseases
- Collaborative company culture headed by an experienced, top-tier management team, invested in your long-term professional development
- Well-funded enterprise with multiple, successful rounds of fund-raising
- Validating collaborations among leading research centers and innovative gene therapy partnerships
- Competitive compensation and benefits
- Jasper Therapeutics is an equal opportunity employer