Senior Clinical Research Associate - #291679
Date: 06/11/2021 10:01 AM
City: Lexington, Massachusetts
Contract type: Full Time
Work schedule: Full Day
Curis is seeking an in-house Senior Clinical Research Associate with oncology experience.
The in-house CRA will monitor the progress of clinical oncology studies at investigative sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The CRA will monitor execution of clinical oncology research studies, in compliance with state and federal regulations and Curis corporate policies to assure accurate and timely completion of studies. Primary scope includes communication with and management of investigational sites regarding study conduct.
The CRA will be responsible for effective global management of relationships and establishes strong partnerships with external team/vendors activities including investigators, CROs, central labs, IRB and other external partners.
- Assist Clinical Trial Managers with day-to-day study activities.
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements.
- Assist in planning, and monitoring clinical research projects.
- Maintain enrollment reports and enrollment projections.
- Assist in Clinical Laboratory Kit distribution.
- Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
- Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements.
- Organize data in systematic manner to allow for efficient and accurate clinical reports.
- Perform co-monitoring visits to ensure regulatory and study requirements are being fulfilled.
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
- Assist in writing/revising clinical portions of Regulatory submissions.
- Interface with medical, clinical, regulatory, drug supply and administrative staff as necessary to accomplish the above responsibilities.
- Perform other clinical duties when requested.
- BS/BA degree or equivalent (background in life sciences preferred)
- Minimum 2+ years of experience working in oncology trials
- Demonstrated knowledge of protocol in oncology studies
- Working knowledge of FDA regulations and ICH/GCP guidelines
- Proven ability to demonstrate strong decision making and problem solving skills
- Must be willing to travel as needed (domestic and international ~20%)
No Phone calls.
Curis is an Equal Opportunity Employer committed to a diverse, inclusive workplace. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.