Lead Clinical Research Associate
Duties and Responsibilities:
The Lead Clinical Research Associate (LCRA)/ Monitoring Oversight Lead (MOL) is responsible for the performance of assigned Field Based Clinical Research Associates (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. (S)he will work cross-functionally with internal and external stakeholders to ensure quality and integrity of data being collected from investigative sites (either on site or remotely) and ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Sponsor or Vendor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. (S)he will provide Sponsor oversight of monitoring activities performed by Contract Research Organizations (CRO), and perform monitoring, co-monitoring, site management and trial management activities for Phase II-IV clinical research projects. Additional responsibilities may be to support Clinical Trial Management activities including identification of investigators, building relationships with investigators/trial site staff, development of Case Report Forms, Trial Master File oversight, implementation of enrollment and recruitment strategies, conducting sponsor oversight visits, preparation of the monitoring plan, oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.
The primary responsibilities for the LCRA/MOL include:
• Oversight of field monitors, including CRO monitors, and site activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
• Develop, execute, manage and ensure compliance of the Monitoring Plan.
• Review trip reports and track scheduling, report submission metrics, deviations from protocol and/or site expectations, and action items.
• Proactively identify, prevent, and mitigate program risks. Manage/resolve site and/or monitoring issues including appropriate retraining, issue escalation, and/or implementing corrective actions to prevent recurrence.
• Develop training materials and study tools for sites and CRAs use.
• Develop and implement enrollment and recruitment strategies.
• Review and provide feedback on study protocols, assist in the design of case report forms, study manuals, and other study documents
• Support other objectives for the clinical operations department (i.e., Safety Report distribution and process development)
Bachelor of Science degree required; Nursing degree is a plus.• CCRA Certification preferred
• Minimum 10 years’ relevant experience in clinical research with at least 5 years monitoring and/or co-monitoring of clinical trials (Phase III required and Oncology experience preferred).
• Preferably experience as a Lead CRA from a CRO and/or pharmaceutical company.
• Extensive knowledge of trial oversight activities is required.
• Experience managing clinical trial vendors preferred
• Ability to plan, organize and prioritize own tasks in a fast paced and changing environment.
• Good oral and written communication skills.
• Ability to work independently as well with interdisciplinary teams (internal and external).
• Result and goal-oriented and committed to contributing to the overall success of Progenics.
• Ability to travel domestically up to 20%-travel to investigator sites for co-monitoring activities.
Technical Skills Required:
• Strong experience with clinical study technologies, including electronic data capture (EDC), interactive response technology (IRT), electronic Trial Master File (eTMF), clinical trial management (CTMS) systems
• Strong proficiency with MS Office Suite
• Have strong written and verbal communication skills
• Have highly effective interpersonal and organizational skills
• Demonstrate the critical elements of GCPs and federal regulations as it relates to clinical monitoring, IRB and Investigator responsibilities.
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