Clinical Research Associate
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, has an opening for an experienced Clinical Research Associate / Sr. Clinical Research Associate (title dependent on experience).
Reporting to the Director of Clinical Operations, you will be responsible for establishing effective working relationships with clinical trial sites and clinical vendors to ensure timely and accurate reporting of trial data.
- Ensure clinical sites are executing research according to the clinical protocol, local regulations, Code of Federal Regulations (CFR), ICH and Good Clinical Practice (GCP) guidelines
- Management of site activities including monitoring recruitment, enrollment, data collection and data entry
- Participate in vendor management and oversight
- Escalate identified risks to the Director of Clinical Operations or appropriate stakeholder and follow through to resolution
- Contribute to the development of study training and ancillary project management materials including databases and trackers
- Serve as study-level in-house CRA and accompany CRO clinical monitors on field visits as required
- Review site level clinical documents (ICFs, IRB approvals, etc.) and clinical monitoring reports; author clinical monitoring reports when needed such as during co-monitoring visits with CRO
- Review and maintain study level clinical plans (including, but not limited to, site monitoring plan, deviation plan, data management plan)
- Manage the Trial Master File (TMF) and perform ongoing quality reviews
- Liaise with the CRO and clinical sites to ensure clinical data is entered appropriately, assist with query and issue resolution, and follow up for collection, submission and QC of clinical imaging
- Support preparation of data and other information for internal and external presentations; participate in internal and external team meetings to share updates on progress of activities
- Support Health Authority Inspections and Inspection Preparedness efforts by company and CRO
- Additional responsibilities as assigned.
Required Skills & Qualifications:
- Bachelor’s degree in related field required. Minimum of five (5) years prior clinical trial experience including full trial lifecycle (site selection, initiation, data gathering, data lock and study close-out). Majority of this experience should be with Oncology clinical trials. Preference given to candidates with previous clinical monitoring experience and those with experience working on pivotal trials with registrational intent.
- Excellent written and verbal communications skills; able to effectively interact with people at all organizational levels and excellent interpersonal skills to establish positive and professional relationships.
- Ability to work independently, prioritize work and function in a matrix team environment.
- Strong understanding of regulatory requirements to ensure all trials comply with established protocols.
- Proficient at using electronic data capture (EDCs), trial master file (TMFs) and interactive response technology (IRTs).
- Proficiency with Microsoft Office Suite including Word, PowerPoint, Excel, Outlook, and Teams.
- Experience with global, early-phase clinical trials (phase I/II) preferred.
- Availability and ability to travel domestically and internationally to clinical trial sites and for internal company meetings is required with potential travel 20% of time.
- Must be located within and authorized to work in the United States today and in the future.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to email@example.com and tell us how you can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
Search Firms and Agency Representatives: Elevation Oncology is not accepting unsolicited resumes from search firms or agencies for any job posting. Resumes submitted to any employee of Elevation Oncology by any search firm or agency without an applicable contract in place will be the property of Elevation Oncology and no fee will be paid.