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Job Summary
Clinical Research Project Manager with monitoring experience
Responsible for the management of multiple clinical research studies. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time. Responsibilities also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities, oversee budget management and subcontracts with associated institutions.
The Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums. The goal is to maximize effective utilization of personnel and resources, while maintaining high levels of quality. The position will be responsible for conducting clinical trial monitoring activities to ensure participant safety, data integrity, protocol compliance, and adherence to applicable regulatory requirements and Good Clinical Practice (GCP) standards. Responsibilities include supporting site initiation, conducting interim monitoring visits, identifying and resolving compliance and data quality issues, and completing site close-out activities to ensure high-quality clinical trial conduct.
Qualifications
. Study Document Development and Management
Prepare study protocols and informed consent forms.
Develop recruitment materials.
Develop manuals of procedures.
Prepare site and staff training materials.
Provide and manage a study portal for access to study documents and trial materials.
2. Regulatory Management
Develop and manage the Investigator’s Brochure, as applicable.
Prepare and submit Investigational New Drug (IND) applications and amendments, as applicable.
Prepare and submit IND expedited safety reports, as applicable.
Prepare and submit IND annual progress and safety reports, as applicable.
Submit Institutional Review Board (IRB) applications and required reports.
Manage site regulatory documents and the Trial Master File (TMF).
Manage ClinicalTrials.gov postings.
Notify the FDA of study closure, as applicable.
3. Investigational Product Management
Purchase and procure investigational products (IP) and placebos.
Develop investigational product labels.
Label and distribute investigational products.
Maintain investigational product records and reporting.
Develop pharmacy manuals.
4. Data Management and Biostatistics
Develop case report forms (CRFs).
Build and manage clinical databases.
Develop the Clinical Data Management Plan, including randomization implementation.
Develop and provide study conduct reports.
Collaborate with biostatistics to build and manage the randomization system.
Collaborate with biostatistics to develop the Statistical Analysis Plan.
Collaborate with biostatistics to conduct data analysis.
5. Safety Oversight and Clinical Trial Monitoring
Administer oversight committees, such as the Data Safety Monitoring Board (DSMB).
Develop pharmacovigilance and safety monitoring plans.
Review safety data.
Report serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to the IRB and sponsor, as applicable.
Develop site initiation and…