Job Information
Loxo@Lilly Contract In-House Clinical Research Associate (CRA) in Helena, Montana
Loxo@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@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 Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Contract In-House Clinical Research Associate 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
Required Qualifications and Preferred 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
Available locations for this role:
Stamford, CT
South San Francisco, CA
Indianapolis, IN
US Based-Remote
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.
Work Environment:
This position’s work environment is in an office.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email loxoaccommodation@loxooncology.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.