Senior Clinical Research Associate II

This is a fully remote position, open to applicants in Finland.

📋 Description

• Conducts site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely, ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and protocol guidelines.

• Utilizes judgment and expertise to assess the overall performance of sites and their staff, providing recommendations for site-specific actions; promptly communicates or escalates serious issues to the project team and formulates action plans.

• Maintains an up-to-date understanding of ICH/GCP Guidelines, relevant regulations, and company standard operating procedures (SOPs) and processes.

• Ensures that the informed consent process is performed and documented adequately for each subject or patient as required.

• Demonstrates a commitment to safeguarding the confidentiality of each subject or patient.

• Evaluates factors that may impact the safety of subjects or patients and the integrity of clinical data at investigator or physician sites, including protocol deviations and pharmacovigilance issues.

• Reviews site processes in accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP).

• Performs Source Document Review of relevant site source documents and medical records.

• Confirms that the clinical data recorded in the case report form (CRF) is accurate and complete through the review of site source documents and medical records.

• Employs query resolution techniques both remotely and on-site, providing guidance to site staff as needed, and ensures query resolution is completed within agreed timelines.

• Leverages available hardware and software to facilitate the effective conduct of clinical study data review and capture.

• Ensures compliance with electronic data capture requirements at the site.

• May oversee investigational product (IP) inventory, reconciliation, and reviews of storage and security protocols.

• Confirms that the IP has been dispensed and administered to subjects or patients in accordance with the protocol.

• Identifies issues or risks associated with blinded or randomized information related to the IP.

• Applies knowledge of GCP, local regulations, and organizational procedures to ensure proper labeling, importation, and handling of the IP.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Ensures that the investigator or physician site understands the requirement to archive essential documents according to local guidelines and regulations.

• Documents activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documents in accordance with SOPs and the Clinical Monitoring Plan/Site Management Plan.

• Aids in subject or patient recruitment, retention, and awareness strategies.

• Inputs data into tracking systems as needed to monitor all observations, ongoing statuses, and action items until resolution.

• Understands the project scope, budgets, and timelines for personal and team activities within the clinical team, managing site-level activities and communications to ensure project objectives, deliverables, and timelines are achieved.

• Must be agile in adapting to changing priorities to meet goals and targets.

• May serve as the primary liaison with study site personnel, or collaborate with the Central Monitoring Associate.

• Ensures that all assigned sites and project-specific site team members receive the necessary training and comply with applicable requirements.

• Prepares for and participates in Investigator Meetings and/or face-to-face meetings with sponsors.

• Takes part in and may lead global clinical monitoring or project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions based on project-specific requirements.

• Offers guidance at both the site and project levels regarding audit readiness standards and assists in preparing for audits and necessary follow-up actions.

• May provide direct supervision, training, and/or mentorship to junior-level CRAs, while also being mentored and assigned lead tasks under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager.

• Supports subject or patient recruitment, retention, and awareness strategies, and may be assigned to develop study and country-level informed consent forms, among other duties.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must display strong computer skills and be open to embracing new technologies.

• Exceptional communication, presentation, and interpersonal skills are essential.

• A moderate level of critical thinking skills is expected.

• Ability to manage travel requirements of up to 75% on a regular basis.

🏝️ Benefits

• We are dedicated to fostering the growth of our employees through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.

• We are committed to cultivating an inclusive culture where you can truly be yourself.

• Driven to Deliver – this embodies the commitment of our colleagues to show up every day and create solutions that can significantly impact someone's life.