Remote Senior Clinical Research Associate (CRA) | Job # 1543
Full Time
South San Francisco, CA 94080
Posted
Job description
Headquartered in Brisbane, Calif., CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
Sr. Clinical Research Associate (Remote)
Responsibilities:
- Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required
- Collaborates with Principal Investigators, study coordinators, and CareDx cross-functional teams
- Ensures compliance with the Study Monitoring Plan, applicable local regulations, ICH/GCP guidelines, and IRB requirements
- Recognizes and resolves ongoing case report form data (electronic data capture) collection issues
- Reviews data queries and listings as well as resolves data discrepancies
- Review and maintain accurate study files, ensuring all appropriate documentation is present
- Evaluates and optimizes systems and processes for the department
In addition, the Sr. CRA may:
- Lead study team meetings for assigned protocol
- Negotiate appropriate terms and conditions of Informed Consent Forms, additional Clinical Agreements, and associated documents
- Participate in protocol development/amendment activities and other study-related materials
- Assist with site recruitment oversight activities
- Mentor junior-level CRAs
Skills:
- Keen understanding of Clinical Study Management industry standards, including monitoring and data management
- Delivers quality according to the requested standards
- Ability to work in an environment of remote collaborators
- Manages change with a positive approach for the self, team, and the business
- Proposes more efficient and effective methods/processes for delivering quality clinical trials
- Strong verbal and written communication skills
- Possess critical thinking ability and analytical/problem-solving skills
- Ability to prioritize and manage multiple tasks with conflicting deadlines
- Uses and develops technical skills while making appropriate use of systems/software
- Maintains team engagement
- Adeptness to respond quickly to shifting demands and opportunities
- Exhibits customer focus in collaboration with sites and external stakeholders
Qualifications:
- Bachelor’s degree in biomedical sciences or related scientific discipline
- 5+ years of experience in the biotech, pharmaceutical, device industry, or academia field, including 3+ years of field monitoring
- Proficient knowledge of FDA regulations and ICH/GCP guidelines
- Experience in the execution of clinical trial registries preferred
- Experience and negotiating contracts and budgets are strongly preferred
- Knowledge of the IRB submission process and requirements is a plus
- Ability to travel up to 40% in support of primary clinical activities
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.
******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.
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