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Clinical Trials Manager

Tufts Medical Center


Location:
Boston, Massachusetts
Date:
04/10/2018
2018-04-102018-05-10
Categories:
  • Clinical Operations
Tufts Medical Center
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  • Research Salary

Job Details

Working under the supervision of the Director of the Neely Center for Clinical Cancer Research, this position is responsible for the management and administration of the Neely Center Cancer Clinical Research Center. This includes management of staff, training activities, development of policies and procedures appropriate for center operations, and interfacing with cancer center leadership and investigators. Responsible for interface with cooperative groups, pharmaceutical company sponsors, monitoring organizations, Regulatory Organizations, inpatient and outpatient facilities, and departmental and non-departmental personnel to assure a collaborative environment and high quality outcomes. Responsible for financial management in collaboration with hospital Research Administration.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS :

Responsible for the supervision (hiring, training and performance evaluation) of Neely Center staff.

Administers Cooperative Group activities (ECOG, Alliance, NRG, etc) grants at the main institution (TMC) and oversees the activity of its affiliates: monitors accrual and delinquency status, coordinates all TMC network activities.

Disseminates information on available clinical trials in written and oral formats to physicians, nurses, clinical studies coordinators, other hospital personnel, and referring physicians as needed

Develops and administers programs to maximize accrual onto clinical trials

Interacts with Principal Investigators (PI's), treating physicians, nurses, inpatient and outpatient facilities, and their personnel to assure compliance to study protocols and requirements.

Oversees data collection and Clinical Study Coordinator activities to monitor quality accuracy, and timeliness of data submission.

Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

Reviews proposed protocols to assess feasibility of undertaking projects.

Collaborates with Tufts MC Research Administration to obtain signed contracts, budgets and other necessary documents.

Oversees and assists in the opening of new studies and creating patient consent forms as needed.

Oversees and assists with ongoing regulatory maintenance

Works to develop short and long term planning objectives for the clinical trials office; works with the affiliate staff to develop satellite sites for the conduct of clinical trials.

Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment

Performs other similar and related duties as required or directed.

JOB REQUIREMENTS:

JOB KNOWLEDGE AND SKILLS:

Experience with management of personnel.

Knowledge of or prior experience with the conduct of major clinical trials.

High degree of organizational, data management and analytical skills.

Requires meticulous attention to detail.

EDUCATION:

Level of knowledge generally obtained through a master's degree in science, business administration, public health, healthcare administration, or nursing.

EXPERIENCE:

7+ years of experience in clinical research operations

Job Type: Full-time

Required education:

  • Bachelor's
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