Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.
We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.
Clinical Research Associate/Senior Clinical Research Associate
Location: South San Francisco, CA or Stamford, CT or Remote
Associate Director/Director, Clinical Operations
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.
The Clinical Research Associate / Senior CRA in collaboration with the Clinical Trial Manager and/or other operational leadership, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
Roles and Responsibilities of the Position*
Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
Contribute to deliverables within study, drive to solutions across a multi-functional study team.
Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
Use performance metrics and quality indicators to assist with driving study execution.
Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
Support Health Authority inspections and CQA audits as required.
Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
Provide proactive identification of potential risks and development/implementation of actions to avoid or mitigate.
Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed. The CRA may have opportunities to lead creation/updates/review of study documents, as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
Participate in vendor specification development and management/oversight. Vendor oversight activities may include responsibility for specific tasks associated with oversight (ie, review of monitoring visit reports generated by CRO) or may opportunities to lead the overall management of a specific vendor (ie, travel vendor), as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
Management of TMF set-up, ongoing quality review, and final reconciliation.
In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
Contribute to development / coordination of study training and study training materials for study team, investigational sites, and vendors.
Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Assist with Investigator Meeting coordination and planning.
In addition to all activities listed, Senior CRAs must be able to manage larger, more complex deliverables within a clinical trial with minimal oversight.
Required Qualifications and Background
BA/BS Degree in a relevant discipline with 2-4 years’ experience in the clinical trial environment required (inclusive of site level or other relevant experience) for Clinical Research Associate level; direct sponsor and/or CRO experience or 5+ years relevant non-sponsor or CRO experience required for Senior CRA level.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Ability to multi-task effectively and prioritize assignments from multiple sources.
Excellent organizational skills.
Strong communication skills, both written and oral; proficiency in English.
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Physical Demands / Travel
The physical demands of this job are consistent with light office duties. Up to 25% travel may be required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is in an office.
The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.