Clinical Research Manager

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $95,000 - $105,000

Position Summary

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 Assistant Director, Clinical Research Operations.

Responsibilities

• 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, 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 CRC's are adequately prepared for and successfully manage all monitoring and/or auditing visits.

• Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.
• Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks.
• Attends regularly scheduled conferences and meetings.

• 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.

• 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 ID's, 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.

• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• 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).

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.