Lightship is the premier provider of enterprise level, technology enabled direct-to-patient clinical research. In this capacity, Lightship functions as a telemedicine-enabled site within a clinical research study, which makes research participation of patients in clinical research possible using technology and home visits by our nurses and other advanced health practitioners.
Lightship is seeking an experienced clinical research professional to join our team as a clinical research associate. The candidate should have in-depth knowledge of GCP, ICH, and other relevant regulatory requirement to planning and conduct of clinical studies. The successful candidate possesses a strong background in study start up, conduct, clinical trial monitoring, quality control and have a history of successfully working with a cross functional study teams and study vendors. The clinical research associate will work directly with a study manager for the successful deployment of clinical studies. They will also work in a pivotal role collaborating with study mangers, study coordinators and research nurses.
This position is a remote position. A successful candidate will possess a willingness and desire to work independently without significant supervision. Additionally, this position may require moderate travel
We would like to offer you:
- An opportunity to help re-envision how clinical research is executed and deliver high-quality research outputs
- The chance to work with a patient-centered, clinically oriented, collaborative team to deliver enterprise grade direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup
- Competitive compensation
- Top notch healthcare (medical, dental, and vision) for you and your family.
- Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
- A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
- Generous paid parental leave
- Short & long-term disability
- Life insurance and More!
You will be responsible for:
- Assisting investigators, sub-investigators, study manager and other Lightship personnel in successful implementation and conduct of clinical research studies
- Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, ICH, FDA, and IRB requirements
- Adhering to study protocol and performing the assigned study tasks per delegation
- Coordinating / conducting study activities with, investigators, clinical research nurses and other study personnel
- Assisting with the preparation, review, and maintenance of essential regulatory documents
- Tracking and reporting study metric to the study management team and management
- Maintaining meticulous accuracy in completing all study documentation (paper and electronic) and ensuring that ALCOA-C standards are upheld, including:
- Assisting in developing informed consent, source forms, case report forms, and other study materials (paper and electronic)
- Assisting investigators, study managers, and other personnel in internal study monitoring activities
- Ensuring data queries and data corrections are completed in a timely manner according to Good Documentation Practices
- Collaborating with patient recruitment team in planning and implementation patient engagement strategies
- Assisting in record retention activities after study is completed
- Coordinating general study activities, including:
- Assisting with study start-up including the development and maintenance of study specific clinical assets
- Assisting with the management of study vendors, including tracking vendor deliverables and invoices according to contracts
- Managing study supplies, materials, equipment and IMP
- Assisting patients, investigators, and study personnel in troubleshooting problems with supplies, equipment, or vendors
- Coordinating and scheduling meetings as requested, including preparing meeting agendas, keeping minutes, and distributing minutes to relevant parties
- Participating in site qualification, initiation, and monitoring visits, as requested; assisting with external and internal audits, as requested
- Assisting with resolving budget questions related to patients’ activities
- Supporting the Study Manager in preparing and distributing study related reporting including but not limited to:
- Screening, recruitment and enrollment metrics
- Timeline maintenance
- Data management including queries, protocol deviations and adverse events
- Other tasks and responsibilities as needed
- Strong communication skills including written and verbal
- Knowledge of ICH /GCP guidelines
- Ability to work with cross functionally and multitask
- Maintain flexibility or have the ability to adapt in a fast-paced environment
- Exceptional time management and organizational skills, with an emphasis on attention to detail
- Strong computer skills including but not limited to Microsoft Office
- 2+ years in clinical research in CRA or equivalent experience required
- Bachelor’s degree in Life Science or healthcare related field preferred
- Previous remote work experience, preferred
- Bilingual, preferred
Our commitment to diversity & inclusion:
Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.
Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.