Sr CRA II

w2 contract role (6-month renewable)

Pay Rate: 64.90/hr

ALL TRAVEL HOURS PAID (door to door)

benefits provided

Job Title:

Senior Clinical Research Associate II (Sr CRA II)

Job Description

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.

+…