Keep the discussion going--join our JobWatch Group on LinkedIn!

Sign In
 [New User? Sign Up]
Mobile Version

Clinical Research Manager

Drexel University College of Medicine

Philadelphia, Pennsylvania
  • Information Systems
  • Data Management
Drexel University College of Medicine
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

To establish and oversee the day-to-day activities of the clinical research trials in the Division of Infectious Diseases and HIV Medicine. To facilitate patient education and recruitment of subjects for studies. Individual will interact with regulatory organizations 
such as the Institutional Review Board (IRB), Office of Research and clinical faculty and other departments. The individual will collect subject data, supervise data entry and data management. When needed individual will also develop IRB submissions, budgets and be responsible for proper research billing practices in accordance with Drexel University College of Medicine policies and procedures. 


Bachelor's degree in a Human Services related field. Master's degree preferred. 
Minimum of three years' experience with clinical research preferred. 

Must be able to function independently with an ability to obtain advice in uncertain clinical situations and handle multi-facets of the study. 
Must be well-organized, detail-oriented and self-directed. 
Must have basic computer skills including the use of data base management and spreadsheet software. 

Must be articulate individual with strong oral and written communication skills. 
Must have a fundamental understanding of clinical research principles and the cooperative group approach to clinical investigation. 
Must be familiar with transportation of hazardous goods procedures. 

Essential Functions 

I. Accurate and timely performance of tasks. 
a. Coordinate program of clinical investigational studies for the Division of Infectious Diseases and HIV Medicine, under the direction of the Division Chief. 
b. Manage communication/correspondence between sponsor and Division investigators for assigned studies. Includes oversight of all site visits as assigned. 
c. Prepare new study proposals and informed consents to be sent to the Institutional Review Board (IRB) for approval. Maintain continued reporting for renewal of ongoing studies. 
d. Manage all communication/correspondence for assigned studies between IRB and Infectious Diseases and HIV/AIDS Medicine Division under the direction of the Division Chief. 
e. Meet with sponsors to open and close studies and maintain regulatory documents for present and future review by sponsor and/or FDA. 
f. Manage and direct patient follow-up. 
g. Collect and enter data on case report forms. 
h. Establish and maintain study files for assigned studies. 
i. Coordinate with laboratory personnel to obtain results and specimens for study. 
j. Communicate with pharmacy, nursing, medical staff and home care agencies to ensure protocol is being followed. 
k. Communicate with home care agency for outpatient treatment. 
I. Communicate with sponsor whenever necessary to report/consult on clinical status of a patient.
m. Oversee research assistants on various clinical trials. 
n. Help develop standard operating procedures for the conduct of clinical research in our Division. 
o. Attend weekly research meetings. 
II. Correctly and accurately participate in Quality Control (QC) and Quality Assurance (QA) programs for sponsors. 
III. Demonstrate professional and courteous behavior. 
1) maintains established professional ethics of project confidentiality as outlined in policies. 
2) works with fellow employees to constructively and expeditiously resolve problems. 
3) Presents professional image of the institution and DUCOM system when attending extracurricular meetings, etc. as required. 
IV. Maintains confidentiality of workplace information according to the policies and procedures of the institution. 
V. Other 

1) Provide access to clinical charts to outside study nurses as directed by Division Chief. 
2) Assist study nurses with patient contact as directed by the Division Chief. 
3) Assist study nurses with patient scheduling. 
4) Provide liaison between outside study nurses 
and co-investigators for the follow-up of clinical events, serious adverse events and deaths. 
5) Implement procedures to maintain patient 
confidentiality as provided by the Privacy Act and FAR Clauses 52.224-2 as well as 
Pennsylvania Act 148. 
6) Adheres to Human Resources policies regarding absences and insures that responsibilities are 
covered during planned absences. 
VI. Performs other duties as assigned by the Division Chief. 

Supplemental Position Information 

Drexel University offers an attractive benefits package including tuition remission, a generous retirement package with matching funds (up to 11 percent) and an opportunity to join a talented team of professionals directly helping the University achieve its record growth and quality reputation. 

Background investigations are required for all new hires as a condition of employment, after the job offer is made. Employment may not begin until the University accepts the results of the background investigation. 

Drexel University is an Equal Opportunity/Affirmative Action employer, welcomes individuals from diverse backgrounds and perspectives, and believes that an inclusive and respectful environment enriches the University community and the educational and employment experience of its members. The University prohibits discrimination against individuals on the basis of race, color, national origin, religion, sex, sexual orientation, disability, age, status as a veteran or special disabled veteran, gender identity or expression, genetic information, pregnancy, childbirth or related medical conditions and any other prohibited characteristic. Please visit our website to view all University Policies and Workplace Postings. 
Powered ByLogo