Men27S Health - Clinical Research Project Manager 40 Hours Days - Bwh

Qualifications:

B.S. Required M.S. preferred.

Minimum 5 years of progressively more responsible clinical research experience.

Prior supervisory experience required.

Skills/Abilities/Competencies Required:

Must possess the ability to work independently and display initiative to introduce innovations to research study.

Must have sound interpersonal skills and the ability to supervise others.

Must possess strong analytical skills and conceptual thinking.

Excellent oral and written communication skills.

Ability to prioritize tasks and set deadlines.

Ability to identify problems and develop solutions.

High degree of computer literacy.

Ability to demonstrate professionalism and respect for subjects rights and individual needs.

Must obtain and maintain certification for Protection of Human Subjects and GCP.

Working Conditions:

Pleasant general office with modern environment/furnishings. Daily interaction with the Operations Director PC study staff and PI. Quiet atmosphere can be fastpaced during deadlines.

Supervisory Responsibilities:

Responsible for supervising staff involved on PC study at the Johns Hopkins site including assistance in evaluating and training and orientation.

Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race sex color religion national origin sexual orientation protected veteran status or on the basis of disability.

General Summary / Overview Statement:

This position will work very independently with guidance from the Operations Director and/or Principal Investigator (PI) on the Prostate Cancer (PC) clinical study in the Mens Health Unit. S/He will coordinate all activities of research including but not limited to: subject recruitment efforts subject study visits IRB protocol development protocol amendments and protocol deviation reporting and other regulatory responsibilities supervising the daily activities of research at the clinical trial site at Johns Hopkins implementing and maintaining quality assurance procedures performing statistical analyses.

Principal Duties and Responsibilities:

1 collaboration with the Operations Director and or PI develops implements and/or maintains an orientation and training program for all staff related to the PC study.

2.May coordinate all (or portion) of research study activities. Function as a resource for all study issues. Identifies problems and develops solutions. This includes acting as lead coordinator on this complicated trial.

3.Designs implements and evaluates recruitment strategies for study participants at both the BWH and Johns Hopkins sites.

4.Interact with patients/subjects with regard to study including patient education procedural instruction and followup. May serve as a liaison between patient and physician.

5.Responsible for overseeing the data collection process. Ensures integrity of patient data.

6.Implements and maintains quality assurance procedures and systems.

7.Plans designs and performs statistical analyses.

8 collaboration with PI prepares and may present certain portions of presentations in addition to preparing articles for publication.

9.May be responsible to monitor study budget in collaboration with the Administrative Director.

10.Has management responsibility for study personnel involved in the PC study including hiring evaluation orientation and training.

11.Serves as the primary contact for outside vendors utilized to ensure efficient operations of the study.

12.On a daily basis executes the procedural managerial and policy decisions made for the study.

13.All other duties as assigned.