Clinical Research Project Manager

Mass General Brigham•Boston, MA

3d•Hybrid

About The Position

The Clinical Research Project Manager with monitoring experience manages multiple clinical research studies and serves as a key liaison with sponsors, IRBs, core laboratories, site principal investigators, and study staff. The role coordinates trial initiation and patient recruitment, expedites project approval and study start-up, contributes to project standard operating procedures, develops recruitment strategies, and oversees budgets and subcontracts. Reporting to and working closely with the Center for Clinical Investigation Coordinating Center (CCI-CC) Director, the Project Manager develops, implements, and manages clinical trial operations for ongoing trials and research consortia. The position aims to use personnel and resources effectively while maintaining high quality. It conducts clinical trial monitoring to protect participant safety, support data integrity and protocol compliance, and ensure adherence to applicable regulations and Good Clinical Practice (GCP) standards. Monitoring work includes supporting site initiation, conducting interim monitoring visits, resolving compliance and data-quality issues, and completing site close-out activities. The role also oversees study document development and management; regulatory submissions and records; investigational product management; data management and biostatistics coordination; safety oversight; site activation, training, and trial conduct; study closure and reporting; and quality assurance and process improvement. The position is hybrid, based at 221 Longwood Avenue, with 40 scheduled weekly hours and a day shift. The stated annual pay range is $63,252.80–$102,596.00.

Requirements

Bachelor’s degree in a related field required; experience in lieu of a degree is not accepted.
Five to seven years of research-related experience required.
Ability to make independent and effective decisions.
Strong organizational and communication skills.
Strong database management and computer skills.
Demonstrated analytical and problem-solving skills.
Strong budget management skills.

Nice To Haves

Master’s degree in a related field preferred.
One to two years of supervisory experience preferred.
Clinical trial monitoring experience preferred.

Responsibilities

Manage multiple clinical research studies and serve as a liaison among sponsors, IRBs, core laboratories, site principal investigators, and study staff.
Coordinate trial initiation and patient recruitment, and expedite project approvals and study start-up.
Participate in developing and maintaining project standard operating procedures; develop recruitment advertising strategies; oversee budgets and subcontracts.
Work with the CCI-CC Director to develop, implement, and manage clinical trial operations for ongoing trials and research consortia, using personnel and resources effectively while maintaining quality.
Conduct clinical trial monitoring to support participant safety, data integrity, protocol compliance, regulatory compliance, and GCP adherence.
Support site initiation; conduct interim monitoring visits; identify and resolve compliance and data-quality issues; and complete site close-out activities.
Prepare study protocols, informed consent forms, recruitment materials, manuals of procedures, and site and staff training materials; provide and manage a study portal for trial documents and materials.
Develop and manage Investigator’s Brochures, as applicable; prepare and submit IND applications, amendments, expedited safety reports, and annual progress and safety reports, as applicable.
Submit IRB applications and required reports; manage site regulatory documents and the Trial Master File; manage ClinicalTrials.gov postings; and notify the FDA of study closure, as applicable.
Procure, label, and distribute investigational products and placebos; maintain related records and reporting; and develop pharmacy manuals.
Develop case report forms, build and manage clinical databases, develop the Clinical Data Management Plan including randomization implementation, and develop and provide study conduct reports.
Collaborate with biostatistics to build and manage randomization systems, develop Statistical Analysis Plans, and conduct data analyses.
Administer oversight committees such as a Data Safety Monitoring Board; develop pharmacovigilance and safety monitoring plans; review safety data; and report SAEs and SUSARs to the IRB and sponsor, as applicable.
Develop site initiation and monitoring plans; conduct site initiation, interim monitoring, and close-out visits.
Conduct site feasibility assessments and approve site activation; provide site training and initiation; oversee recruitment, informed consent, and participant research procedures; ensure appropriate recording of AEs, SAEs, and SUSARs; and investigate and remediate site noncompliance.
Oversee site closure and required reporting; coordinate return or destruction of unused investigational products; notify the IRB of study closure; prepare and submit final study reports; oversee archiving of site records, including the site Trial Master File; coordinate publication of trial findings; and collaborate with biostatistics on final data analysis.
Oversee the development, implementation, and administration of quality assurance processes; develop metrics and tools to monitor, trend, and report performance; and facilitate or participate in stakeholder communications regarding training, performance measures, and quality assurance.
Supervise and train staff.