Clinical Research Compliance Specialist

Overview: At Alliance Clinical Network we're people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day.

As a Clinical Research Compliance Specialist you will support 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.

Benefits include medical, dental, vision insurance, 401(k) retirement plan with a company-match, paid time off and company holidays.

Essential Duties and 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.

Qualification Requirements: To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Education and Experience:

• 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.

Special Skills, Knowledge, and Abilities:

• 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. Celebrates successes.
• Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions.
• 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.

Certificates, Licenses, Registrations: Maintain GCP certification and other on-the-job certifications as required.

Travel Required: 5-10% (candidates will travel between 2 local facilities)

Physical Demands and Working Conditions: The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to stand, walk, sit, kneel, use hands to finger, handle, or feel, and talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• This job requires Specific vision abilities, including close vision, depth perception, and the ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• An essential function of the job is to be able to comply with all applicable federal, state and local safety and health regulations that would apply to this job.
• The employee must move about the workspace to access work surface and shelves, cabinets, drawers, and equipment that are at, below or above the work surface.
• Nothing in this job description limits management’s right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor is it intended to be an all-inclusive list of the skills and abilities required to do the job.

While every attempt has been made to outline the basic job responsibilities, adjustments in the process may change and expand the job duties. In addition, employees may be asked to perform duties outside of this description at the discretion of the Executive Management Team.