Clinical Research Project Manager

Rex Laboratory Services   •  

Chapel Hill, NC

Industry: Misc. Healthcare

  •  

5 - 7 years

Posted 340 days ago

Description

Clinical Research Project Manager

Job Summary:
The UNC HCS Office of Research Support & Compliance (ORSC) is the coordinating center for clinical trials and research in participating UNC HCS Network Entities. ORSC responsibilities include administration and support for the participating sites with respect to regulatory compliance, Good Clinical Practice and overall quality assurance. This position requires local travel within the state of North Carolina to UNC HCS network entities. Travel to conferences, training and possibly, to Investigator Meetings, may also be required.

Responsibilities:
• Provide oversight, project management, project coordination, and quality assurance monitoring for clinical trials and research studies
• Communicate with the network entities, maintaining positive and cooperative relationships in day-to-day interactions with investigators and study sties
• Serve as a conduit to advocate and facilitate System collaborations
• Participate in the execution of clinical trials and research studies including, but not limited to:
o Create and update study manual of operations and standard data collection procedures for all participating sites;
o Provide education and training to physicians and staff at UNC HCS Network Entities, as assigned;
o Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol;
o Provide patient care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research practices;
o Collaborate to create study-specific informed consent document template, as required;
o Prepare sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies, and conducting site initiation visits;
o Maintain master trial files, and manage the study progress in relation to project timelines;
o Ensure sites’ compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms;
o In collaboration with the Program Manager, conduct ongoing site quality assurance visits, and prepare detailed visit reports;
o Maintain accurate records of the receipt, inventory, and dispensation of study drug, devices and materials. Work with the site-based nursing staff, to ensure administration of study drug to research subjects as defined by the study protocol;
o Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as required by the study protocol. Provide processing and shipment of samples per protocol.
o Comply with standard operating procedures of the sponsor, institutional review board (IRB), UNC HCS and/or consortium involved with the trial.
o Conduct remote source data verification of CRF critical data elements;
o Screen all adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study sponsor and all participating site IRBs;
o Attend investigator and coordinator meetings and teleconferences, as required;
o Participate on relevant research committees when appropriate;
• Develop forms, processes, SOPs and policies, as required

Qualifications

Required Qualifications:
• RN with current North Carolina license
• At least 5 years’ experience in clinical trials research, preferably as a project manager;
• Proficient in electronic data capture systems;
• Exceptional attention to detail;
• Able to multi-task and manage competing priorities effectively;
• Understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research;
• Experience in reading medical records;
• Willingness to travel up to 50% of the time;
• Certification as a clinical research associate or the equivalent is desirable;
• Training/experience as a clinical monitor

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