Sr CRA II

Senior Clinical Research Associate II (Sr CRA II)

This Senior Clinical Research Associate II role performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. The position focuses on ensuring protocol and regulatory compliance, maintaining audit readiness, and protecting participant rights and data integrity in accordance with ICH-GCP, applicable regulations, and standard operating procedures. The Sr CRA II conducts both remote and on-site monitoring visits, manages documentation and systems, and develops strong collaborative relationships with investigational sites across various sponsor and monitoring environments.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process for assigned studies.
• Conduct remote and on-site monitoring visits using a risk-based monitoring approach to assess protocol adherence and regulatory compliance.
• Apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and define corrective and preventive actions that bring sites into compliance and reduce risk.
• Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review, using both on-site and remote monitoring activities.
• Assess investigational product accountability through physical inventory checks and detailed records review.
• Document observations, findings, and follow-up actions in monitoring reports and correspondence, using approved business writing standards and submitting documentation in a timely manner.
• Escalate observed deficiencies, issues, and potential risks to clinical management promptly and track all issues through to resolution.
• Maintain regular communication with investigative sites between monitoring visits, as needed, to confirm protocol compliance, follow up on previously identified issues, and ensure timely and accurate data entry.
• Conduct monitoring activities in accordance with the approved monitoring plan and study-specific procedures.
• Participate in the investigator payment process by providing accurate and timely information and documentation as required.
• Share responsibility with project team members for resolving site issues and findings, and investigate and follow up on findings as applicable.
• Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) and update study systems, including the Clinical Trial Management System (CTMS), according to study conventions.
• Perform quality control checks of reports and data generated from CTMS or other study systems when required.
• Participate in investigator meetings as needed, supporting site staff training and alignment with study requirements.
• Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigative sites.
• Initiate clinical trial sites in accordance with relevant procedures to ensure compliance with the protocol, regulatory requirements, and ICH-GCP obligations, making recommendations where appropriate.
• Ensure proper trial close-out at investigative sites, including retrieval of trial materials and verification of final documentation.
• Confirm that essential documents are complete, accurate, and filed appropriately according to ICH-GCP and applicable regulations.
• Conduct on-site investigator site file reviews in line with project specifications and timelines.
• Contribute to project deliverables by assisting in the preparation of project publications, tools, and study-related materials.
• Support the project team by performing additional study tasks assigned by the CTM, such as reviewing trip reports, creating newsletters, and leading CRA team calls.
• Facilitate effective communication between investigative sites, the sponsor, and the internal project team through clear written, oral, and electronic communications.
• Respond to company, sponsor, and regulatory requirements, including participation in audits and inspections, and support timely resolution of audit findings.
• Complete administrative tasks, including expense reports and timesheets, accurately and within required timelines.
• Contribute to process improvement initiatives and other project work aimed at enhancing quality, efficiency, and consistency across studies.

Essential Skills

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or an equivalent and relevant formal academic or vocational qualification.
• Previous experience comparable to at least 2+ years as a clinical research monitor or Clinical Research Associate.
• Valid driver's license, where applicable.
• Effective clinical monitoring skills, including on-site and remote monitoring.
• Demonstrated understanding of medical and therapeutic area concepts and medical terminology.
• Excellent understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including a critical mindset, in-depth investigation capabilities, and the ability to perform root cause analysis and problem solving.
• Ability to manage and apply risk-based monitoring concepts and processes.
• Strong oral and written communication skills, with the ability to communicate effectively with medical and clinical personnel.
• Ability to maintain strong customer focus through active listening, attention to detail, and sensitivity to underlying site or sponsor concerns.
• Effective interpersonal skills and strong attention to detail.
• Strong organizational and time management skills, with the ability to prioritize tasks and manage multiple assignments.
• Ability to remain flexible and adaptable in a wide range of scenarios and changing study requirements.
• Ability to work effectively both independently and as part of a multidisciplinary team.
• Proficient computer skills, including solid knowledge of Microsoft Office applications and the ability to learn new software and clinical systems.
• Good English language proficiency and grammar skills.
• Strong presentation skills for site meetings, investigator meetings, and internal team communications.

Additional Skills & Qualifications

• Experience working in varied monitoring environments such as full-service outsourcing (FSO), functional service provider (FSP) models, and government-sponsored studies.
• Experience developing collaborative relationships with investigational sites and site staff.
• Familiarity with Clinical Trial Management Systems (CTMS) and other study tracking tools.
• Experience supporting or participating in investigator meetings and site initiation visits.
• Experience contributing to project publications, tools, and communication materials such as newsletters.
• Demonstrated ability to support audits and inspections by sponsors or regulatory authorities.
• Comfort working in a large, global contract research organization environment supporting diverse therapeutic areas and leading pharmaceutical and biotechnology companies.
• Ability to contribute to process improvement initiatives and cross-functional project work.
• Combination of education, training, and directly related experience may be considered to meet role requirements.

Work Environment

This position is 100% home-based, providing the flexibility of working remotely while supporting clinical trial sites. The role requires significant travel, typically 6080% of the time, with an average of 810 overnight visits per month to investigative sites. You will use standard office technology, including Microsoft Office and clinical trial systems such as CTMS, to manage documentation, communication, and study tracking. The work involves regular virtual and in-person interactions with site staff, internal project teams, and sponsors, and requires comfort with frequent travel, varying site environments, and a mix of remote and on-site responsibilities.