Job Overview

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

Essential Functions

•  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 plan 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. Escalate 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. May support start-up phase.
•  Ensure copies/originals (as required) 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 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.
•  If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
•  If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

•  High School Diploma or equivalent Degree in scientific discipline or health care preferred.
•  Requires at least 4 years of year of on-site monitoring experience.
•  Equivalent combination of education, training and experience may be accepted in lieu of 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 as provided in company training.
•  Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
•  Written and verbal communication skills including good command of English language.
•  Organizational and problem-solving skills.
•  Effective time and financial management skills.
•  Ability to establish and maintain effective working relationships with coworkers, managers, and clients.