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Research Project Coordinator Cardiology

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Company: Baylor Health Care System

Location: Plano, TX

Date Posted: July 2, 2014

Source: Baylor Health Care System

Job Location: Plano, TX

Under general direction of a Research Program Team Leader, the Research Program Coordinator is responsible for planning, developing, implementing, managing and reporting on multiple aspects of a multidisciplinary research program. The Research Program Coordinator will use project management skills and tools to develop and implement strategies that ensure timely advancement of a proposed research program to meet intended goals and objectives while complying with all institutional, federal and state rules and regulations and funding constraints. The Research Program Coordinator will motivate positive working relationships within the program team, including internal and external team members. The Research Program Coordinator will organize, direct and develop team resources to effectively meet program commitments.

Job Functions

I.Work with team leader and others as appropriate to define the strategicinitiatives, scope, goals and timelines of the Research Program

II. Develop Program budgets and ensure that budget requirements are met,including review ...

Job Location: Plano, TX

Under general direction of a Research Program Team Leader, the Research Program Coordinator is responsible for planning, developing, implementing, managing and reporting on multiple aspects of a multidisciplinary research program. The Research Program Coordinator will use project management skills and tools to develop and implement strategies that ensure timely advancement of a proposed research program to meet intended goals and objectives while complying with all institutional, federal and state rules and regulations and funding constraints. The Research Program Coordinator will motivate positive working relationships within the program team, including internal and external team members. The Research Program Coordinator will organize, direct and develop team resources to effectively meet program commitments.

Job Functions

I.Work with team leader and others as appropriate to define the strategicinitiatives, scope, goals and timelines of the Research Program

II. Develop Program budgets and ensure that budget requirements are met,including review of Program-related contracts and approval of invoices withinthe Program budget

III. Use project management skills to ensure that the Program progressesaccording to established timelines

IV. Serve as the Program’s liaison with internal and external departments andpersonnel involved in or contributing to the Program to resolve barriers to theadvancement of the Program’s strategic initiatives

V. Foster relationships with external entities, including academia and thepharmaceutical and biotechnology industry; maintain current relationships andestablishing new relationships with entities that can contribute to the objectivesof the Program

VI. Design and implement processes and procedures to ensure advancement of theProgram’s strategic initiatives

VII. Provide guidance to Program team members and interact regularly with theProgram team to determine resource needs, coordinate activities of operationalareas and identify deliverables and target due dates

VIII. Organize and conduct team meetings to ensure adherence to strategicinitiatives, goals, budget and timelines

IX. Continually evaluate staff performance and progress against deliverables;identify and resolve issues that may impact Program timelines and budgets

X. Communicate Program status internally and externally and seek help withissues that cannot be resolved at Program team level

XI. Implement and execute management decisions

XII. Ensure efficient communication and reporting of the operational activitiesrelated to the Program by Program team members

XIII. Provide Program representation for internal and external meetings (e.g. partnerships)

XIV. Provide Program leadership through Program team management and evaluation

XV. For clinical research programs:

1 Design and prepare clinical development plans

2 Engage internal and external experts as necessary to develop the clinical studydesign

3 Assist in the selection of potential investigators

4 Present clinical rationale and clinical protocol at Investigators’ meetings

5 Prepare supporting documents, including the clinical protocol, Investigator’sBrochure, case report forms, informed consent documents and components of anIND application

6 Complete regulatory filings for product candidates

7 Provide necessary support to extramural investigators to support regulatory filings

8 Schedule and organize meetings with regulatory authorities

9 Track and report on progress of clinical research studies

10 Organize and monitor data collection and analysis

11 Identify and ensure timely filing of any intellectual property generated by the Program

12 Plan and support any communication activity linked with the Program, for bothscientific and public relation purposes

13 Serve as single point-of-contact for clinical research studies

Qualifications

I.Masters degree in the life sciences with at least 5 years of successful experience or M.D.,

Ph.D., and/or Pharm.D. with at least 3 years of successful experience in preclinical and clinical

drug development in a field relevant to the Program, including prior project management within

pharmaceutical, regulatory or clinical areas

II.Minimum of 5 years clinical research experience in a field relevant to the Program

III.Knowledge of clinical drug development and regulatory processes in a field relevant to the

Program

Req ID:184694_1

Job ID: 184694_1

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