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Clinical Rsch. Prog./Proj. Mgr

Company: Massachusetts General Hospital(MGH)
Location: Charlestown
Posted on: May 18, 2018

Job Description:

The Huntingtons Disease Clinical Translational Research Program is hiring a highly motivated individual to run our clinical program. Receiving very general direction from the Principal Investigator, the incumbent will oversee and manage the HD clinical translational program and its clinical trials research. The position requires a comprehensive and detailed understanding of Institutional Review Board (IRB) and clinical research procedures, as well as management skills with a high degree of initiative and independent judgment. The incumbent should demonstrate basic competency for caring for patients with cognitive and behavioral impairment, including impaired decision making capacity.



Principal Duties



Manage all aspects of the clinical research protocol, including all clinical and neuropsychological and biomarker assessments, ensures that clinical data bases are kept up to date.

Manages all study related documents including Institutional Review Board protocols and continuing reviews, Investigational New Drug applications, and other regulatory documents related to the clinical protocols.

Interprets and applies GCP and IRB policies to support research compliance.

Coordinates training program for, and oversight of, clinical coordinators/staff and manages assessment of competency for lab members with regards to data acquisition and analysis.

In charge of establishing and monitoring safe, compassionate and excellent practices clinical research, which aims to provide the highest quality environment for performing patient-oriented research with patients suffering from serious neurologic and psychiatric illnesses while maintaining the safest practice standards.

Assists in the preparation for Clinical Trial Monitoring visits and internal/external reviews.

Establishes standards for the delivery of research procedures, acts as a role model by providing excellent service to internal and external contacts.

Evaluates and standardizes operating procedures (SOPs) and effectively troubleshoots and resolves issues.

Is a resource for patients and staff

Recruit participants for research protocols

Attends bi-weekly clinic and reports study progress as appropriate.



Regulatory:

Provide oversight and advise Clinical Research staff

Drawing on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines, participate in the design and implementation of new proposals and projects, as appropriate

Plan and conduct project team meetings

Participate in planning and implementing training opportunities/programs

Lead in the timely execution of high quality clinical research projects leveraging knowledge, expertise, and risk mitigation.

Build effective, high performance teams via expert communication, decisiveness, prior experience and technical expertise

Lead all activities relating to formal communication with regulatory agencies (FDA, Health Canada, etc), funding agencies (NIH, industry sponsors, foundations, etc) and safety monitoring boards

Troubleshoot study/portfolio related issues and escalate, as appropriate

Take on additional tasks and responsibilities, as requested.







Skills/Abilities

* Excellent written and verbal communication skills

* Advanced time management and analytical skills.

* Ability to organize information.

* Ability to handle sensitive information with absolute confidentiality.

* Knowledge of Institutional Review Board applications.

* Working knowledge of software applications including Microsoft Word, Excel and Power Point.

* Ability to make decisions independently and/or to escalate issues as needed.

* Ability to seek information and second opinion when needed.

* Ability to problem-solve, suggest and implement solutions, as needed.

* Dependability, perseverance, flexibility and skills as a team player

* Ability to multitask in a challenging environment.

* Excellent communication skills.

EDUCATION:

BS degree in health related field

Nursing degree or associated health care related degree highly preferred.



EXPERIENCE:



Minimum of 5 years of clinical research experience, including management of all stages of interventional drug trials from study start up though data lock and study close out.



SUPERVISORY RESPONSIBILITY (if applicable):

Supervises day to day operations of all study staff



WORKING CONDITIONS:

Day to day operations are performed at the Charlestown Navy Yard.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged

Keywords: Massachusetts General Hospital(MGH), Boston, Clinical Rsch. Prog./Proj. Mgr, Healthcare, Charlestown, Massachusetts

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