Senior Clinical Research Program Manager

Clinical Research Project Manager/ Site Activation Specialist

Provides management of research administration at a clinical site(s) including monitoring the quality and accuracy of clinical trial data. Follows the established monitoring Standard Operating Procedures (SOP) and protocol-specific monitoring plan. Participates in site initiations and trainings.

Job Responsibility

• Trains, coaches, supports and mentors Site Clinical Research Managers and other team members.
• Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture.
• Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies.
• Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct.
• Participates in site initiations and trainings.
• Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability.
• Performs study close-out monitoring activities.
• Provides pre-review assistance prior to regulatory inspections and submissions.
• Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA.
• Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns.
• Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff.
• Assists in developing appropriate education and training sessions for investigators and clinicians involved in research.
• Works on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
• Regularly makes new recommendations on new processes, tools, and services that can impact multiple projects and other functions.
• May provide technical guidance and direction to support team members, contractors and/or other vendors.
• May serve as project/technical lead for ongoing processes or short-term projects within function or family.
• Performs related duties, as required.

Job Qualification

• Bachelor's Degree or equivalent combination of education/related experience, required. 3-5 years relevant experience, required.
• Working knowledge of FDA regulatory processes, including IND submissions, preferred
• Familiarity with ClinicalTrials.gov registration and maintenance, preferred
• Ability to manage multiple projects and collaborate across team, preferred
• Experience in an academic medical center or cancer research environment, preferred
• Exposure to IIT lifecycle from concept through activation, preferred