Senior Clinical Research Associate

This is a fully remote position, open to applicants in Sweden, +1 more country.

📋 Description

• Independently carry out site monitoring functions for clinical trials.

• Provide leadership, guidance, and oversight to Clinical Research Associate (CRA) teams.

• Ensure compliance with project scope, standard operating procedures (SOPs), timelines, budgets, study protocols, and Good Clinical Practice (GCP) requirements.

• Review monitoring visit reports and conduct co-monitoring and evaluation visits.

• Coordinate cross-functional resolution of issues related to clinical trial monitoring.

• Assist with the development of Monitoring Plans, training presentations, ethics documentation, and negotiations related to site contracts.

• Conduct qualification, initiation, interim, and close-out visits, both remotely and onsite.

• Prepare accurate monitoring visit reports that detail site issues, resolutions, protocol deviations, study progress, and enrollment metrics.

• Review source documents and ensure the integrity of Case Report Form (CRF) data.

• Conduct quality control checks of electronic Trial Master File (eTMF)/Trial Master File (TMF) documents and oversee investigational product accountability.

• Review regulatory binders for sites and maintain ongoing communication with study sites.

• Monitor patient enrollment and respond to requests from sponsors.

• Facilitate the reporting of adverse events and reconcile Serious Adverse Event (SAE) reports with source documentation and CRFs.

• Resolve discrepancies in data queries with CRAs/Clinical Trial Coordinators (CTC) and data management teams.

• Identify issues at sites and develop effective problem-solving strategies.

• Prepare sites for audits.

• Participate in internal meetings, client/sponsor discussions, scientific forums, and other relevant gatherings.

• Train and mentor new CRAs.

• Collaborate on the development and maintenance of Clinical Trial Management Systems (CTMS).

• Provide monthly billing information and manage budgets for standalone projects.

• Handle conflicting priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• At least 4 years of clinical monitoring experience in the pharmaceutical, biotechnology, or Contract Research Organization (CRO) sectors.

• Ability to independently manage monitoring activities.

• Experience in oncology.

• Willingness to travel within Denmark and Sweden.

• Fluency in Danish, Swedish, and English.

• A quality-focused mindset; meticulous, thorough, and detail-oriented.

• Strong organizational skills with the capacity to multitask in a dynamic environment.

• Proficiency in managing priorities, organizing time, and solving problems efficiently.

• Strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership capabilities.

• Willingness to travel and ability to manage stress effectively.

• Professional demeanor, trustworthy, and disciplined in approach.

• Aptitude for solving unstructured or ambiguous challenges.

• Proficient command of local languages and English for EU monitoring activities.

• Excellent communication and interpersonal skills with a focus on customer service.

• Competent in using computers, including familiarity with clinical trial management systems, clinical trial databases, and electronic data capture tools.

• Knowledgeable about clinical research, ICH GCP, local regulations, and regulatory and ethical requirements.

• Ability to build and maintain positive relationships with sponsors, sites, and project team members.

• Degree in a scientific health-related field.

• Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or a related scientific health discipline.

🏝️ Benefits

• Flexible remote work arrangements.

• Part-time work schedule.

• Contingency Workforce contract.