CareDx

About CareDx

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. Regional CRA- East Coast (Remote) Responsibilities: Identifies, evaluates and establishes clinical trial sites. Collaborates with Principal Investigators, study coordinators and CareDX sub team, developing study protocols, case report forms and patient recruitment programs, achieving protocol adherence targets. Ensures compliance with the Study Monitoring Plan, applicable local regulations, ICH/GCP guidelines and IRB approvals. Recognizes and resolves ongoing case report form data (electronic data capture) collection issues. Reviews data queries and listings as well as resolves data discrepancies. Reviewing and maintaining accurate study files ensuring all appropriate documentations are present. Evaluates and optimizes systems and processes for department. Manages budgetary relationships with the investigators and centers. Negotiates appropriate terms and conditions of Informed Consent Forms, additional Clinical Agreements and associated documents. Liaises with regulatory authorities. Skills: Keen understanding of Clinical Study Management, 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 self, team and the business. Proposes more efficient and effective methods/processes of delivering quality clinical trials. Strong verbal and written communication skills. Possess analytical and problem-solving skills. Ability to prioritize and manage multiple tasks with conflicting deadlines. Uses and develops computer skills while making appropriate use of systems/software in an e-enabled environment. 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’ experience in biotech, pharmaceutical, device industry or academia field. Proficient knowledge of FDA regulations and ICH/GCP guidelines. Experience in execution of clinical trial registries. 3+ years of onsite monitoring experience and negotiating contracts and budgets are strongly preferred. IRB submissions and requirements knowledge is a plus. Ability to travel up to 75% 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.

Synonyms

Technologies (from Job Ads)

Hiring Locations

Headquarters

Loading map...

Company Info

Legal Form: AB

Company Type: Public

Company Size: 51 - 250

Revenue: 25 - 50 million (USD)

Job Ad Metrics

Job Ads found: 74

Job Ads per Month: 2.7

Hiring Locations: 2

Data Info