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Clinical Research Manager II

2 months ago

Remote, Oregon, United States Parexel Full time

Join us in making a difference in clinical research.

The Clinical Research Associate serves as the primary liaison for clinical sites, responsible for overseeing site quality and performance from the initial identification phase through to the final close-out. This role is essential in fostering strong relationships with sites, ensuring accountability for site performance, and implementing effective patient recruitment strategies. The Clinical Research Associate will assess compliance with regulatory standards and the site's ability to meet study requirements, while also resolving any issues that may arise during the process.
Responsibilities include managing the trial's execution at designated sites, safeguarding the rights and welfare of participants, and ensuring the integrity of the data collected. The Clinical Research Associate will also evaluate staff training effectiveness and develop strategies for patient recruitment, while maintaining compliance with the approved protocol and applicable regulations.
An initiation Clinical Research Associate (iCRA) may be designated to manage pre-site initiation activities and support protocol amendments as necessary.

Key Responsibilities:

Start-up Phase:

Act as the primary contact for assigned sites, ensuring quality and timely delivery during the start-up phase.

Establish and nurture relationships with investigators and site personnel. Conduct feasibility assessments and site qualifications, which may include:

-Preparation and negotiation of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA).
-Conduct remote Qualification Visits (QVs).

Generate reports from visits and utilize problem-solving skills to address site-related issues. Develop and manage strategies for the preparation and approval of essential regulatory documents. Customize and negotiate Informed Consent Forms (ICF) and any necessary amendments. Prepare and submit applications to IRB/IEC and regulatory authorities, ensuring follow-up until final approval is received. Maintain the trial master file in accordance with project plans and company policies. Proactively identify and resolve site-related questions and issues, including potential risks to activation timelines and patient recruitment strategies. Facilitate access to study systems for allocated sites and ensure compliance with training requirements. Participate in Investigator meetings, audits, and regulatory inspections as required. Work independently with minimal oversight, while keeping management informed of progress and challenges.

Maintenance Phase:

Serve as the primary contact for assigned sites, ensuring adherence to study protocols and addressing any site issues that arise.

Foster relationships with investigators and site staff. Support sites in accessing relevant study systems and ensure compliance with training requirements. Evaluate on-site staff assignments and implement corrective actions as necessary. Address and resolve site issues, including training needs and documentation deficiencies. Follow up on outstanding issues from previous visits. Respond to site-related inquiries promptly. Utilize knowledge to identify and address data quality and integrity issues. Participate in internal and external meetings, audits, and inspections as required. Review and approve updated site documentation, including regulatory documents. Collaborate with site staff to evaluate and enhance recruitment strategies. Conduct on-site visits and remote contacts as needed. Generate visit reports and assess site compliance and performance. Manage study supplies and ensure proper documentation of their status. Monitor site payment statuses and follow up on data entry and queries. Conduct site-specific training as necessary. Assess site facilities and recognize the impact of non-compliance on study timelines.

Overall Responsibilities:

Ensure timely completion of project objectives and maintain accurate trial management systems.

Collaborate with team members to achieve project goals and encourage support among colleagues. Maintain up-to-date Clinical Trial Management Systems (CTMS) and ensure high-quality data entry compliance. Ensure assigned sites are prepared for audits and inspections. Monitor compliance with ICH-GCP and relevant regulations. Delegate tasks to administrative support as needed and provide guidance. Demonstrate commitment to high-quality work and foster a positive work environment. Maintain knowledge of applicable guidelines, regulations, and company policies. Provide feedback for performance evaluations and strive for continuous improvement. Complete additional administrative tasks in a timely manner.

Required Skills:

Strong problem-solving abilities. Initiative and independence in work, with a proactive approach to seeking guidance. Excellent presentation and communication skills. Client-focused mindset. Flexibility in adapting to new tasks and learning opportunities. Ability to prioritize and manage multiple tasks effectively. Strong decision-making skills in ambiguous situations. Team-oriented attitude and appreciation for collaboration. Proficiency in Clinical Trial Management Systems (CTMS) and MS Office applications. Attention to detail and commitment to quality work. Ability to mentor and support team members. Willingness to travel as required by the study phase.

Experience and Education:

Significant experience in site management or clinical research, with a solid understanding of trial methodologies. Degree in biological sciences, pharmacy, or a related health discipline preferred, or equivalent nursing qualification.

EEO Disclaimer:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.