Clinical Research Associate II

Company DescriptionPSI is a leading Contract Research Organisation with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job DescriptionAs a CRA II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.

Home-based position from anywhere in DenmarkYour responsibilities will include:

Conducting and reporting all types of onsite monitoring visitsDriving the study startup phase (if applicable)Performing CRF reviews, source document verification and query resolutionBe responsible for site communication and managementSupervising study activities, timelines, and schedules for each siteActing as a point of contact for in-house support services and vendorsSupporting quality control, such as compliance monitoring and reports reviewParticipating in feasibility researchSupporting the regulatory team in preparing documents for study submissions and regulatory approvalQualificationsDegree in Life Sciences (or similar), or an equivalent combination of education, training & experienceAt least 2 years of experience conducting independent on-site monitoring visits, ideally on multiple projects at a timeDemonstrable experience in all types of monitoring visits in Phase II and/or IIINative/Fluent Danish and advanced EnglishStrong written and verbal communication skillsIntermediate to Advanced knowledge of MS OfficeAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills are essentialAs you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel.

Experience supporting Gastroenetreology studies is an assetAdditional InformationMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.