Cancer Center Jobs

Clinical Research Manager - Clinical Protocol & Data Management

Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center

February 17, 2022
Clinical Research Manager

Columbia University

Herbert Irving Comprehensive Cancer Center – Clinical Protocol and Data Management office

Scope:
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.

Description:
Responsibilities include, but are not limited to:

STAFFING

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)

SUPERVISION

Monitors, directs, and supervises staff in a manner that facilitates 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 CRCs 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 a multidisciplinary team 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, training, etc.

OTHER

Performs other related duties as assigned.

Requirements:
(Applicant MUST meet these minimum qualifications to be considered an applicant):

Bachelor’s Degree or equivalent in education, training and experience, plus 4 years of related experience

Preferred Qualifications: 
Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.

Other requirements:
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).

To apply: https://opportunities.columbia.edu/en-us/job/522026/clinical-research-manager

Or email: [email protected]