Senior Clinical Research Associate

Cynet Systems•Durham, NC

About The Position

Perform monitoring and site management work to ensure that sites are conducting studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Requirements

Requires at least 4 years of on-site monitoring experience.
In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong therapeutic and protocol knowledge.
Computer skills including proficiency in Microsoft Word, Excel, PowerPoint, and the use of laptops and mobile devices.
Strong verbal and written communication skills.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and stakeholders.

Nice To Haves

Bachelor's Degree in a scientific discipline or healthcare field preferred.
An equivalent combination of education, training, and experience may be accepted in lieu of a degree.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, escalating quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution, with potential support during the start-up phase.
Ensure copies or originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP, ICH, and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and completing other required study documentation.
Act as a mentor for clinical staff, including conducting co-monitoring and training visits.
Collaborate and liaise with study team members for project execution support as appropriate.
Support the development of project subject recruitment plans on a per-site basis, as applicable.
Manage site finances according to executed clinical trial agreements and retrieve invoices in accordance with local requirements, as applicable.