Senior Clinical Research Associate II

Syneos Health

Clinical Research Associate managing site qualification and monitoring compliance for clinical trials. Joining Syneos Health to work within an integrated life sciences team.

Posted 5/21/2026full-timeRemote • 🇫🇮 FinlandSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Demonstrates diligence in protecting the confidentiality of each subject/patient.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP).
Conducts Source Document Review of appropriate site source documents and medical records.
Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Verifies site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
Verifies issues or risks associated with blinded or randomized information related to IP.
Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Supports subject/patient recruitment, retention and awareness strategies.
Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.
Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
Must be able to quickly adapt to changing priorities to achieve goals/targets.
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
May provide direct supervision, training and/or mentorship to more junior level CRAs. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.
Supports subject/patient recruitment, retention, and awareness strategies. May be tasked to develop study and country level informed consent forms, among other responsibilities.

Requirements

What you’ll need

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills.
Moderate level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis.

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.
Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Good Clinical PracticeICH Guidelinesclinical data reviewsource document reviewquery resolutioninvestigational product managementdata entryclinical monitoringprotocol complianceclinical trial management

Soft Skills

communication skillspresentation skillsinterpersonal skillscritical thinkingadaptabilityteam collaborationproblem-solvingmentorshipleadershiporganizational skills

Certifications

Bachelor’s degreeRegistered Nurse (RN)