Senior In-House CRA

Summary:

The Remote based, Senior In-house CRA performs a key role in building relationships with site personnel (clinical coordinators, study investigators, pharmacists), while contributing significantly to the management and execution of the clinical trial. CRAs will collaborate with other cross-functional team members in this high-profile role. They will communicate regularly with Clinical Trial Managers (CTMs) regarding work progress and apply knowledge of clinical site and vendor oversight. The Senior In-house CRA will also provide oversight of monitoring activities and may be expected to co-monitor with CRO or contract CRAs, and/or as a primary site monitor for study sites.

Responsibilities:

· Assist in the development of informed consent forms.

· Assist in the development of study training materials, study plans and study tools.

· Provide critical review of site monitoring visit reports.

· Track metrics for monitoring visits and monitoring visit reports and document trends.

· Ensure the Monitoring Plan is followed.

· Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Management.

· Conduct remote and/or on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study.

· Work closely with Clinical Supplies to ensure timely drug delivery to sites and resolve outstanding site action items related to investigational product.

· If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff.

· Participate as needed in site study drug training (unblinded CRA role).

· Perform in-house clinical study data review.

· Create and maintain study-related tracking tools.

· Assist in the review and maintenance of the clinical Trial Master File; perform study file audits.

· Participate in review and QC of study documents (protocol, ICF template(s), TMF, etc.) and the user acceptance testing of EDC and IRT systems.

· Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO’s CRAs on these activities.

· Provide guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions.

· Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified.

· Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.).

· Partake in regular team meeting/teleconferences.

· Participate/present at CRO, Vendor and Investigator Site meetings as necessary.

· Participate/present at Site and Investigator Meetings as necessary.

· Regular Travel Required: 25-30%

Qualifications:

· BS degree in life sciences or healthcare discipline.

· At least 5 years of clinical operations experience including 2 years of recent experience monitoring oncology trials preferred.

· Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.

· Demonstrated efficiency in partnering with CROs and vendors.

· Maintain professionalism in difficult situations.

· Remain flexible in terms of assignments in support of a trial.

· Ability to remain organized while effectively managing time and assigned tasks.

· Good verbal and written communication skills; enjoys frequent interaction with others.

· Able to work in a face pace environment.

· Able to prioritize tasks and work independently.

· Works collaboratively in a small team environment.

· Experience working with EMR, EDC, eTMF and CTMS systems.

· Able to travel an average of 25%, both domestically and internationally.

· Global experience required