At Lensa, a dynamic biotech firm headquartered in Gaithersburg, MD, the In-House Clinical Research Associate plays a pivotal role in propelling clinical programs forward. This position anchors the transition from preclinical promise to human trials, ensuring rigorous oversight of studies that could redefine treatments in oncology and rare diseases. Fully remote, it demands precision and initiative in a fast-evolving pharmaceutical landscape. Day-to-day, the role centers on developing and refining clinical study protocols tailored to Phase I-III trials, incorporating FDA feedback loops for seamless submissions. Expect to conduct virtual site initiation visits, training investigators on GCP compliance while tracking enrollment metrics through real-time dashboards. Collaborate cross-functionally with biostatisticians to analyze interim data, flagging safety signals via MedDRA coding, and preparing IND amendments. Routine tasks include auditing source documentation remotely via EDC systems like Veeva or Medidata Rave, resolving queries to maintain data integrity, and contributing to DSMB reports that guide trial pivots. The successful candidate will manage 4-6 active sites per protocol, fostering relationships to boost retention amid competitive recruitment. Candidates must hold a Bachelor's in life sciences, nursing, or pharmacy, backed by 3+ years in clinical research, ideally within biotech CRA roles. Proficiency in ICH-GCP guidelines and eTMF management is non-negotiable, alongside hands-on experience with CTMS platforms. CCRP or ACRP certification strengthens applications. Technical prowess in protocol design and pharmacovigilance pairs with soft skills like adaptive problem-solving and meticulous attention to regulatory nuances. Strong virtual communication enables effective stakeholder alignment, while analytical acumen turns complex datasets into actionable insights. Lensa cultivates a collaborative, science-driven culture where remote teams connect via innovative platforms, emphasizing work-life balance and continuous learning. Professional growth thrives through mentorship and conference access in the vibrant Gaithersburg biotech hub. Compensation features market-rate salary, comprehensive health coverage, generous PTO, and 401(k) matching.