Senior Clinical Research Associate

Cynet Systems•Durham, NC

8d•Onsite

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

Bachelor's Degree in a scientific discipline or healthcare preferred.
Requires at least 4 years of on-site monitoring experience.
An equivalent combination of education, training, and experience may be accepted in lieu of a degree.
In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Strong therapeutic and protocol knowledge.
Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, 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 effectively working relationships with coworkers, managers, and clients.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., 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/originals (as required) 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, if applicable.
Manage site finances according to executed clinical trial agreements and retrieve invoices according to local requirements, if applicable.