- Meet with the Research team regularly to review consortium projects and action item
- Maintenance and update of the petal website with the web designer monthly
- Updating and other websites monthly and as needed
- Schedule and organize the PETAL Consortium Retreat/Symposium and semiannual meeting
- Develop written materials for internal and external audiences in alignment with program and consortium goal
- Contribute to the strategic development of the PETAL Consortium
- Promote consortium efforts to collaborate with Marketing and Development in seeking gifts for PETAL Consortium
- Contribute to and foster a team environment
- Scientific writing activities will largely be comprised of organizing the workflow and coordination of investigators and CRCs performing components of larger research projects.
- Facilitate the coordination of major translational research platforms, including but not limited to blood, plasma collection, liquid biopsy, and serial biopsy
- Contribute to other strategic planning and special project oversight as requested
- Contribute towards preparation of progress reports of the consortium and submission to sponsor
- Research opportunities for collaboration with outside academic and industry entitie
- Develop and manage Investigator's Brochure (if applicable)
- Prepare and submit Investigational New Drug (IND) application and amendments (if applicable)
- Prepare and submit IND Expedited Safety Reports (if applicable)
- Prepare and submit IND Annual Progress and Safety Reports (if applicable)
- Submit IRB Applications and required reporting
- Manage site regulatory documents and Trial Master File (TMF)
- Manage posting
- Notification of study closure to FDA (if applicable)
- Assist in preparation of protocol and informed consent form
- Prepare Recruitment material
- Oversee preparation of Manuals of Procedure
- Oversee site and staff training material
- Manage study portal and access to study documents and trial material
- Assist in developing Case Report Form
- Assist in development study conduct report
- Administer oversight committees such as Data Safety Monitoring Board
- Develop Pharmacovigilance / Safety Monitoring plan
- Review of safety data
- Report SAE/SUSARS to IRB
- Develop site initiation and monitoring plan
- Conduct site initiation
- Conduct interim monitoring
- Conduct site close-out
- Site feasibility assessment
- Approve site activation
- Provide site training and initiation
- Investigation/remediation of site non-compliance
- Site closure and reporting
- Monitor return / destruction of unused IP (if applicable)
- Notification of study closure to IRB
- Prepare and submit Final Study Report
- Archival of site records including site TMF
- Oversee publication of study finding
- Oversees development, implementation and administration of quality assurance. This includes continuous development of metrics and tools to monitor, trend, and report performance measure
- Facilitates and/or participates in communication with internal and external staff as it relates to training, performance measures, and quality assurance
- Strong verbal and written communication skill
- Ability to proactively anticipate and identify issues/projects and initiate plans to addre
- Self-motivated, independent and strong problem-solving skill
- Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization
- Ability to document and communicate the status of progress against plans, taking corrective action as necessary
- Analytical skills necessary to comprehend complicated issues and formulate creative solutions for problem solving
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Senior Project Manager, Center for Clinical Investigation, Coordinating Center - Boston, United States - Brigham & Women's Hospital(BWH)
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Description
General Summary/Overview Statement:
The Coordinating Center Senior 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.
Integration of machine learning and genomics to predict outcomes for newly diagnosed, relapsed and refractory mature T-cell and NK-cell neoplasms: a global study of the PETAL
Consortium.
The goal is to maximize effective utilization of personnel and resources, while maintaining high levels of quality.
Principal Duties and Responsibilities:
Serves as a liaison between the PETAL Consortium investigators, REDCap, biostatistics team, BostonGene team and Ikigai Labs Team
This includes:
oMaintaining a list of all participating investigators, their research teams, legal contract teams and administrative teams, REDCap team, BostonGene and Ikigai Labs Team
oOrganizing regular monthly meetings of the consortium members, setting up agenda ahead of the meeting, recording minutes at each meeting and taking key notes from each meeting including voting and consensus and following up on all discussions.
oDeveloping a plan for all projects, proposals of the consortium on a regular basis and ensuring follow-up on all discussions, and requesting an update on projects on at least a bi-monthly basi
oReview new projects and LOI's with Steering Committee members and progress of each project with key investigators for each proposal
oReview data collection and quality of data collection with REDCap manager at each participating institution and ensure compliance
oReview regular upload of data onto Ikigai Labs platform by serving as liaison between REDCap data manager and Ikigai Labs personnel.
oTracking payment as part of subcontracts made to each participating institution
Works closely with the CC Director and Assistant Director to oversee a core group of staff who will manage and perform the following:
Regulatory
Qualifications
Qualifications:
Bachelor's degree required, Master's preferred
At least 5 years of clinical research experience
Ideally, minimum of 2 years working within an academic clinical trial coordinating center
High proficiency with Microsoft Office, particularly with Excel
Skills/Abilities/Competencies Required:
Excellent interpersonal skills, with ability to interact all levels of the organization and foster collaboration
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead.
All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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