Experience:
No experience
Employment Type:
Full time
Posted:
8/23/2017
Job Category:
Health Care Provider
Clinical Research Manager
(This job is no longer available)
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Job Description

JOB TITLE: Clinical Research Manager

Location: Louis Stokes Cleveland VA Medical Center

Reports To: Executive Director, Cleveland VA Medical Research and Education Foundation

POSITION OBJECTIVE

The Clinical Research Manager (CR Manager) will manage the day-to-day activities of the Clinical Research Center (CRC), and will thereby support the various components of the Center's multi-disciplinary clinical research programs. The manager is responsible for the overall management and administration of active CRC protocols and associated activities. This position serves as the primary departmental resource for all aspects of CRC programming, and is responsible for ensuring that trials are administered consistent with sponsorship guidelines and quality standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

(The functions listed below are characteristics of the type of work associated with this job title. They are not all-inclusive)

Responsible for the daily administration and management of all aspects of the clinical trials/ clinical research program. Oversees scheduling and utilization of the CRC Clinical space.

Supervises the daily activities of the clinical coordinators as well as regulatory coordinators, ensuring prompt and accurate submission of protocols and related information required for study review, approval and management.

Oversee the planning, tracking and management of operational budgets to include the allocation of resources along project timelines.

Serves as a departmental resource and advisor to clinical trials coordinators and research staff. Assists study coordinators and researchers with questions associated with clinical trials administration, IRB coordination, and related matters. Functions as the departmental content expert for all clinical trials. Serves as a mentor for new research staff. Provides initial and on-going education to Investigators and research coordinators. Prepares study tools such as self-assessment checklists, source document templates, tracking logs, study activities flow chart, etc. Educates staff regarding new policies and procedures. Provides ongoing education to research coordinators as requested or needed by reviewing/ clarifying VA policies and procedures and/or helping them prepare study tools and organized study files. This education is provided either by meeting with the CRC Manager one on one and/or by email/phone consultation.

CR Manager will perform initial and annual assessments for all RNs and LPNs affiliated with the CRC. WOC staff, employed by the VA Foundation, will have their entire assessment performed by CR Manager. This includes core competencies as well as research specific competencies. VA staff nurses will have only research specific competencies assessed by the CR Manager. VA "research only" staff will have the entire assessment performed by CR Manager.

Assists faculty and administration with the recruitment, applicant interviewing, assessment and hiring processes for new research coordinator staff. Obtains input from Principal investigators (PI) during the annual performance evaluation process.

As needed, the CR Manager will provide support for approved research projects by performing nursing functions. For example, study related exams, vital signs, EKG, Phlebotomy, obtain biological specimens (blood, urine), IV insertion and support.

Works with the CRC Medical Director, PI and Executive Director of the Cleveland VA Medical Research and Education Foundation (CVAMREF) to actively recruit for new clinical trials to assist in the successful growth of the CRC, and to determine the feasibility of incoming research proposals including development and review of clinical trial budgets.

Trains new and existing staff on department standard work practices, flows, documentation methods, and overall study administration processes. Assists administration with the development and implementation of new clinical trials administration methods.

Develops and administers quality assurance protocols designed to monitor and improve the accuracy and integrity of all core elements of the clinical trials program, including: participant selection and enrollment; clinical trial protocol compliance; regulatory paperwork preparation by study staff participant flow and satisfaction; consent documentation; data collection and reporting.

Maintains working knowledge of FDA and related regulatory agency requirements and standards as related to the clinical trial industry.

Actively participates in new study proposal development and preparation

Together with the CRC Medical Director, the CR Manager and CVAMREF Executive Director serves as a primary point of contact and communication with all external and internal stakeholders regarding clinical trials activities. Manages stakeholder communications and relationships with appropriateness and professionalism.

Maintains effective relationships with individuals and contacts within the LSCVAMC Research Service. Utilizes discretion in the communication of study-related information. Adheres to regulatory requirements regarding the communication of protected health information.

Performs all duties and responsibilities in a fashion which coincides with the LSCVAMC mission statement towards patients, visitors, staff, peers, physicians and others within the system.

Performs other related duties as instructed by the CRC Medical Director.


About the Company

The Cleveland VA Medical Research and Education Foundation (CVAMREF) is a nonprofit organization that is affiliated with the Louis Stokes Cleveland Department of Veterans Affairs (VA) Medical Center. CVAMREF provides a flexible funding mechanism to support research and education at the Cleveland VA. Our mission is to promote research partnerships to advance the success of VA research.

Qualifications

Applicants must be eligible to work in the specified location