Precision for Medicine

As a Clinical Research Associate II, you will monitor clinical studies at investigative sites, ensuring they're conducted and reported per protocol. You'll coordinate activities, identify investigators, and help prepare regulatory submissions with an impeccable eye for detail. You will identify risks and take responsibility for the quality of your work.

Lead new and existing CRO laboratory projects, accelerating the development and adoption of novel therapeutics. Manage assay development, clinical testing, biorepository/sample management and logistics, and kitting for client studies. Accountable for overall project/portfolio performance, serving as the cross-functional lead and monitoring operational delivery against contracted timelines and budget.

Provides overall support to study sites and clinical project teams engaged in clinical research studies, adhering to applicable protocols, SOPs, and regulatory requirements. Acts as point of contact for study sites and expected to work independently in providing support to CRA and sites. Can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.

Monitor and own the progress of clinical studies at investigative sites, ensuring clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

As the hub of central intelligence for studies, you will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery; addressing the challenges facing the research and development of novel compounds in Oncology and dedicated to positively impacting the health and lives of patients around the world.

The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company. This includes oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation.

The Manager Clinical Monitoring offers an additional development path for clinical research professionals. This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful.

Monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate all activities to set up and monitor a study. You will identify investigators and help prepare regulatory submissions.