Clinical Research Compliance Specialist

ALLIANCE CLINICAL LLC • Lewisville, TX

136d

About The Position

The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents.

Requirements

• An associate degree in healthcare or a related field is preferred.
• At least two (2) years of clinical research experience as a Clinical Research Coordinator (CRC) or one (1) year of experience as a Clinical Research Associate (CRA) is required.
• Proficient in Microsoft Word, Excel and Adobe Acrobat.
• Working knowledge of medical and/or clinical trial terminology.
• Working knowledge in relevant scientific fields.
• Strong attention to detail.
• Must be able to prioritize competing demands.
• Must possess excellent verbal and written communication skills.
• A proven ability to multi-task in a rapidly changing environment.

Nice To Haves

• Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.
• Adapts quickly to changing priorities to perform as needed in his/her role.
• Remains calm when faced with changes to (and in) his/her work.
• Effectively relays understanding of diverse perspectives.
• Can handle communication upwards and downwards as needed.
• Presents information in a clear, well-thought-out way and tailored to the audience.
• Shows support for the new direction even when the details have not been finalized.
• Spots early indications of underperformance and takes corrective actions.
• Works with partners inside his/her function to find the best solutions that align with functional priorities.
• Supports the creation/implementation of data management plans by understanding site/study data sourcing techniques and overall compilation.
• Independently assists data management tasks/processes in line with study-related data plans.
• Identifies and resolves data queries and requirements based on knowledge of the origin, flow, and management of data through a clinical study.
• Ensures compliance with SOPs related to data quality within assigned studies.
• Contributes to study management and research procedures by consistently executing assigned tasks in compliance with GCP guidelines, with minimal supervision.
• Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support).
• Shows awareness of basic safety, ethical, and HPP considerations, and regulatory requirements in terms of documentation and study conduct.
• Assists in the development of relevant technical, study, and/or regulatory materials to ensure compliance with regulatory, safety, & ethical requirements.

Responsibilities

• Conduct SOP/GCP/Compliance Training with coordinators at site.
• Ensure sites are adhering to ACN’s policies and procedures.
• Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity.
• Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures. Escalate significant findings to CTNx Management.
• Coach and Support CRCs and PIs on a continuous basis based upon audit findings.
• Monitor the protocol and regulatory compliance of clinical research studies (with low —to high-risk research designs) in multiple treatment areas.
• Review research data from source documentation for accuracy, completeness, and timeliness.
• Collaborate with the offshore compliance team and the onsite study team to effectively address critical findings.
• Strictly adhere to confidentiality and compliance standards.
• Collect, review, maintain, and audit essential documents.
• Assist with developing documents and implementing study-specific risk monitoring plans.
• Support ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities.
• Serves as the main point of contact in compliance audits and interim monitoring visits.
• Read and comprehend new research protocols as well as amended protocols.
• Meet assigned targets, goals, and completion deadlines.
• Utilize analytical, problem-solving, and critical thinking.
• Utilize precise attention to detail.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Comply with all company policies, procedures, and conduct.

Benefits

• 401 (k) Retirement Plan
• Medical, Dental, and Vision Insurance
• Paid Time Off (PTO)
• Floating Holidays
• And more!

What This Job Offers

• Education Level: Associate degree