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

Jasper Therapeutics

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Senior Clinical Trial Associate