"Clinical Research Manager"

Position Summary

Contributes to the management and oversight of clinical trials. Works closely with Principal Investigators (PI), Regulatory Affairs and Study Team to coordinate and ensure the successful completion of the clinical activities within the agreed timelines and budget, and in compliance with the required quality, Good Clinical Practice and ICH Guidelines. Overall, will coordinate activities related to clinical studies, monitor and document progresses. Serves as liaison between site personnel and the sponsor.

Job Responsibilities

• Participates in the oversight and monitoring of investigator/coordinator compliance with IRB and institutional requirements and the approved protocol.
• Conducts site-initiation visits, routine and closed out visits to assure adherence to local and federal requirements.
• Conducts monitoring activities for Department's research clinical trials including pre-of source documentation to confirm subject eligibility, confirmation of informed consent and to validate accuracy and completeness.
• Responsible for identification of any serious adverse events and protocol deviations at the site; ensures that these are appropriately reported.
• Issues data query forms to the study team; anticipates, recognizes and resolves issues proactively with the site study team; provides the monitoring reports in detail for the regulatory files.
• Communicates with investigators and the study team, and ensure compliances with protocols, regulatory requirements, and good clinical practices; assists site personnel with internal audits or regulatory inspections.
• Assures that research regulatory documents are filed and maintained in accordance with FDA regulations, ICH guidelines, local regulations and SOPs.
• Serves as liaison between site personnel and the sponsor.
• Serves as the primary Clinical Research Coordinator/Monitor of pharmaceutical clinical trials in the department.
• Performs PFTs as a back for the research subjects of department
• Manages and monitors all aspects of the compliance with IRB and institutional requirements and the approved protocols.
• Manages all financial transactions related to subjects/patient care services, for accuracy and compliance.
• Performs the function of a Clinical Research Coordinator on all Pharmaceutical trials that are not in conflict with trials monitored under this role.

Education

• Bachelor's Degree

Experience

An academic degree in Life Sciences and good knowledge of good clinical practice and local regulations.

Minimum of five years with on-site monitoring activities, preferably in genetics medicine and pulmonary medicine.

Experiences with FDA Audit and/or Federal Regulatory agencies preferred

Extensive technical knowledge of the functioning of IBCs, DSMBs and IRBs, including extensive knowledge of the technical requirements of the federal regulations that govern human subjects research, adverse events reporting, state laws governing research, and WCMC policies

Comprehensive and practical knowledge of the principle of clinical trial conduct in accordance with ICH/GCP and other clinical trials-related regulations or guidelines

Thorough knowledge of clinical development processes and conduct of clinical studies.

Knowledge, Skills and Abilities

• Excellent communication skills.
• Strong analytical and problem solving skills.
• Demonstrated organizational skills and ability to pay close attention to detail.
• Dependable, self-motivated and able to work with minimal supervision.
• Good computer skills.

Licenses and Certifications

• Certification with CCRP and/or CCRA preferred.