About Us:
At BlossomHill Therapeutics, we are on a mission to redefine precision medicine and make a leap forward in life expectancy and quality of life for patients. Our cancer therapies are exquisitely designed to be potent against cancer drivers and aim to address cancer's resistance to treatment from multiple angles. Our autoimmune programs seek to tackle difficult challenges to deliver life-changing therapies for patients.
Driven by a desire to transcend incremental improvements to existing drugs, we approach drug design from the ground up. Combining human intelligence, creative thinking, and proven drug design expertise, we are dedicated to developing small-molecule masterpieces that have the potential to set new standards for cancer and autoimmune disease treatment.
Job Summary:
The Clinical Research Associate will provide support to the Senior Director, Clinical Operations in managing and tracking key study deliverables and milestones. This position will play a key role in contributing to the oversight of the clinical monitoring function across trials. This includes, but is not limited to: CRO monitoring oversight, developing and implementing best practices in clinical operations, conducting and facilitating data monitoring and cleaning to ensure consistency and good quality, and ensuring that study deliverables are timely, and are compliant with the protocol and ICH/GCP guidelines.
Key Responsibilities:
- Ensure timely and accurate study-related communication to internal and external study teams.
- Provide oversight of CRO monitoring activities to ensure good quality, and regulatory and protocol compliance.
- Identify site risks and escalates these to the Senior Director, Clinical Operations with suggested mitigations.
- Assist with the review and development of study-specific protocols, CRFs, clinical study plans, manuals, tools, trackers and templates, etc.
- Ensure that sites and investigators adhere to the established clinical protocol, regulatory requirements, ICH/GCP, and provides input into data validation.
- As needed, conduct occasional on-site and remote monitoring to ensure consistency and good quality across studies, support achievement of company timelines, and provide CRO/vendor/contractor oversight and Sponsor level site engagement.
- Review monitoring visit reports and escalates pertinent issues to the Senior Director, Clinical Operations.
- Assist with the development and implementation of site-specific recruitment plans.
- Assist with the review of site reference materials, e.g., screening logs, Delegation of Authority Log, etc.
- Assist with site feasibility, qualification, and selection process; conduct site monitoring visits, manage study monitoring schedule in collaboration with the CRO, audits CRFs for conformity to source documentation, assesses and improves monitoring performance of CRO.
- Set data entry, monitoring and query resolution related target timelines and oversees adherence to these timelines.
- Manage and help create monitoring and site management related clinical trial tracking metrics and reporting for internal and external collaborators.
- Participate in selection and management/oversight of external vendors and assists in development of vendor specifications.
- Support Senior Director, Clinical Operations with oversight of TMF completeness, timeliness, and quality of filed documents.
Qualifications:
- Bachelor's degree in Biology, Biochemistry or other life science field of study; or relevant work experience.
- Minimum 5 years of experience directly supporting oncology clinical research trials in-house at a pharmaceutical company or CRO.
- Experience in small molecule studies strongly preferred.
- Ability to work independently and within a team-oriented environment with minimal supervision.
- Excellent interpersonal, written, and verbal communication skills.
- Ability to travel up to 20% of time to clinical sites.
AAP/EEO Statement:
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Notice to Outside Recruiters: BlossomHill Therapeutics does not accept unsolicited resumes from recruiters or employment agencies.