Clinical Research Program/Project Manager

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POST DATE 10/10/2017
END DATE 12/12/2017

Massachusetts General Hospital(MGH) Charlestown, MA

Location
Charlestown, MA
AJE Ref #
579723055
Job Classification
Full Time
Job Type
Regular
Company Ref #
3037819
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

GENERAL SUMMARY/ OVERVIEW STATEMENT:



We seek an energetic, organized, and detail-oriented project manager, with substantial experience in the conduct of cardiovascular clinical research studies. The Project Manager will be responsible for providing managerial, logistical, and administrative direction for Dr. Lubitzs research group under the general direction of the Principal Investigator, the physician investigators, and the Clinical Research Program Manager.



The Project Manager will be responsible for managing the day-to-day operations for a large-scale clinical trial at Massachusetts General Hospital. The candidate will organize project staff meetings, and communications with research nurses, physicians, clinical research coordinators, and high-level administrative staff. In addition, the Project Manager will oversee operational aspects related to electronic scientific data capture, financial and administrative information, develop best practices, create SOPs, assist with IRB submission and revisions, oversee regulatory registration and requirements (e.g., clinicaltrials.gov), oversee training of research staff to comply with study protocols, coordinate with institutional partners to assist with study execution, and assist professional staff in the dissemination of research and operational efforts through presentations and written material. The position requires strong leadership, project development skills, and the ability to work well in a team-based environment. While this is not a clinical position, it requires a good knowledge of basic clinical concepts and an understanding of how and when to communicate with clinicians. The Project Manager position requires the ability to be highly self-directing, resourceful, professional, and organized. The Project Manager will help ensure smooth communication and follow-up among all staff working with study subjects.

PRINCIPAL DUTIES AND RESPONSIBILITIES:



The incumbent will:



* Present reports defining project progress, problems, and solutions

* Implement new initiatives to support research mission and goals of excellence

* Liaise with Research Management, Partners Human Research Committee, Research Ventures and Licensing, Partners Clinical Trials Office, and other MGH and Department groups on Project initiatives or performance improvements

* Organize, facilitate, and implement operational meetings, training seminars, and study-specific team meetings

* Develop, monitor, and report on study budgets

* Provide fundraising and grant-writing assistance as necessary

* Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs

* Coordinate and supervise efforts for studies and provide guidance to the study specific staff in protocol implementation, meeting recruitment goals, performing clinical procedures, and managing data collection

* Establish recruitment strategies and assure implementation and goal attainment on trials and other funded research

* Monitor study performance for subject accession and data acquisition in accordance with the protocols and conveys information to PI

* Work with marketing staff to create print and web presence/material about the studies

* Assess educational needs of investigators and study staff, design training projects and conduct or facilitate individual and/or group training sessions

* Lead performance improvement initiatives for the study staff to ensure that researchers are in the best environment to succeed

* Serve as primary resource for all regulatory and operational aspects of the studies, overseeing submission and maintenance of documentation

* Design and implement quality assurance systems to assure compliance

* Assist with expediting funding and study start-up at MGH and other participating centers

* Oversee collection and integrity of study data

* Oversee regulatory affairs of the study

* Field study staff questions on a day-to-day basis

* Meet regularly with study PI, research nurses, and research coordinators

* Assist with audit preparation as necessary

* Accept responsibilities for special projects as requested





QUALIFICATIONS:



A minimum of 3 to 5 years of clinical research experience interacting with patients and the medical system as related to the duties and responsibilities specified. Experience with IRB administration and data management is required. Prior supervisory experience preferred. Experience with clinical trials strongly preferred


Bachelors degree required, masters degree preferred.



SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:



Excellent critical thinking skills and ability to work independently are essential

Must be self-motivated, and highly resourceful

Excellent verbal and written communication skills

Effective analytical and creative problem solving skills that support sound decision making,

Excellent discretion and judgment with the ability to problem solve independently, and knowing when to escalate to leadership

Ability to prioritize, delegate, and manage multiple responsibilities

Flexibility and organizational skills in a fast-paced, complex environment

Efficiency and sound leadership skills

Ability to navigate within a complex organization, e.g. to understand fit with organizational goals/priorities, build consensus, facilitate decision-making

Ability to maintain the utmost confidentiality of sensitive and personal information

Strong computer skills--Proficiency in Word, PowerPoint, Excel--are essential

Excellent communication skills with research staff and senior leadership

Ability to provide leadership for a large project with many small parts

Ability to establish priorities and react promptly to a wide variety of requests and needs

Strong knowledge of IRB processes and approval mechanisms included in ongoing IRB oversight

Knowledge of Good Clinical Practice (GCP) guidelines

Ability to develop templates, organize technical information, and maintain functional schedules

Ability to educate and conduct training sessions both on individual and group levels

Knowledge of and compliance with all hospital, State, and Federal regulatory requirements, including hospital policy and procedures, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Comfort interacting and communicating effectively with high-level hospital administration, physicians, Principal Investigators, all levels of hospital staff, external funding agencies, and maintain a variety of internal and external contacts

Possess an excellent command of the English language

Knowledge of medical terminology





WORKING CONDITIONS:



Clinical and office settings.



SUPERVISORY RESPONSIBILITY:



Incumbent will screen, hire, orient, and supervise staff members. Supervision of 2-8 Clinical Research Coordinators and collaboration with 1 research nurse.





FISCAL RESPONSIBILITY:



With the help of a Grant Manager, the incumbent will be responsible for developing, monitoring, and providing regular updates to the PI and the Program Manager on numerous study budgets. The Project Manager will be responsible for the purchasing of study-related equipment and