Clinical Research Manager
- Requisition no: 522026
- Work type: Full Time
- Location: Medical Center
- School/Department: Herbert Irving Comprehensive Cancer Center
- Grade: Grade 105
- Categories: Health/Clinical
- Job Type: Officer of Administration
- Regular/Temporary: Regular
- Hours Per Week: 35
The candidate will be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs) and Data Coordinators(DCs); creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies. The Clinical Research Manager reports directly to the Clinical Research Program Manager.
Responsibilities include, but are not limited to:
Posts/justifies new and replacement positions, screens applicants
On-boards and trains staff (protocol, university, departmental training)
Liaises with the HICCC HR representative for scheduling medical surveillance, JCAHO, and other HR-related functions.
Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals)
- Monitors, direct, and supervises staff in a manner that facilitates an efficient level of operations.
- Determines CRC and DC workloads and protocol assignments.
- Assures the subject data collected by the CRCs is organized and submitted in a timely manner.
- Develops quality control mechanisms to ensure accurate data reporting.
- Assists with CRF development, accuracy, and implementation for investigator-initiated trials.
- Ensures CRC’s are adequately prepared for and successfully manage all monitoring and/or auditing visits.
- PROTOCOL MANAGEMENT
- Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.
- Organizes projects and collaborates with multidisciplinary teams and other health care personnel as needed to complete assigned tasks.
- Attends regularly scheduled conferences and meetings.
- DEPARTMENT INITIATIVES
- Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs).
- Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
NCI RELATED FUNCTIONS
Assumes the role of site Clinical Research Associate (CRA) for the National Clinical Trial Network Programs (Alliance, SWOG, other) if assigned this role.
Manages and submits NCI research base membership applications for new investigators and research staff.
Ensures staff access and training on various NCI consortia group systems; obtains CTEP IDs, establishes roles and privileges, and maintains rosters.
Works with the CPDM Compliance Core to create a Q/A oversight plan for internal monitoring of NCI-sponsored trials.
Obtains, reviews, disseminates data quality reports to PI’s and research staff, including component sites. Enforces data quality, timely submission, and query resolution.
- Performs other related duties as assigned.
- Bachelor’s Degree or equivalent in education, training, and experience, plus 4 years of related experience.
- Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.
Minimum one year of supervisory experience
Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
Excellent interpersonal and organizational skills.
Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.