Senior Clinical Research Associate/ Task Manager I

Provides clinical operations and site monitor leadership and management.  Responsible for monitoring all types of clinical trials. Assures adherence to ICH Good Clinical Practice, investigator integrity, and compliance with protocol and all study procedures.  Performance of this position requires considerable on-site commitment at investigational sites.  Identifies and resolves problems in the study monitoring process and co-ordinates monitoring activities across projects.  May serve as the Clinical Team Leader for small projects or projects of low complexity, or as local/regional Lead CRA / Clinical Team Leader (CTL) as required, and manage CRAs to conduct effective site monitoring.  Serves as mentor to more junior staff.

Job Responsibilities:
Primary responsibility  is site management and performance (including documentation) of in-house and on-site monitoring (all types of visits) activities for multiple investigational sites in accordance with designated project assignment (including applicable SOPs, GCP and applicable international/national regulatory requirements)
Assists in co-ordination of translation of applicable study documents, for example consent forms, as required.
Participates in CRA training programs, and serves as a mentor for more junior staff.
May serve as the Clinical Team Leader for small projects or projects of low complexity, or  serves as local/regional Lead CRA/ CTL with responsibility for managing a certain subset of clinical activities as required.
In Lead CRA / CTL role, reviews CRA site visit reports and is responsible for checking that  reports are completed, and distributed in accordance with the applicable SOPs and International/National regulatory requirements, project scope of work, approved budget and timelines.
Identifies and records non-conformity with Company procedures and SOPs, and recommends and implements corrective and/or preventative action.  Ensures that conformity occurs.

Job Qualifications:
Prefer RN, BSN, BS/MS or BA in Health or Biological Sciences and 2-4 years related experience, or two-year Associates degree and 3-5 years experience in health related field, or high school diploma or equivalent and 7 or more years related experience.
At least three years clinical monitoring experience, encompassing all the activities of a Clinical Research Associate (all types of monitoring visits) required
Computer literacy required, including well-developed computer skills in MS Word and Excel program experience preferred.
Sound knowledge of medical terminology
Advanced working knowledge of clinical monitoring responsibilities, procedures (SOPs),  and ability to apply GCPs, ICH and applicable National and International regulatory guidelines are essential.
Demonstrates strong clinical monitoring and operations knowledge and experience (all types of monitoring visits). Understands roles and interactions between the support functions in the clinical study operations process including safety, regulatory, biometrics, data management, and clinical suppliesEffective verbal and written communications skills.  Good command of English, spoken and written, essential