CLINICAL PROJECT MANAGER / 40 HOUR / DAY / BWH DIV. OF MEDICINE-PULMONARY

Responsibilities

GENERAL SUMMARY/ OVERVIEW STATEMENT

Working under the general direction of the Director and the Laboratory Manager of the Asthma Research Center (ARC), the Project Manager (PM) develops, implements and oversees several research study protocols funded by the NIH and pharmaceutical companies. The PM is responsible for all aspects of the clinical trials with which s/he is involved. This includes screening, enrolling and following subjects through the trials, managing the administrative aspects of these trials, training appropriate staff, and monitoring the studies progress to assure data quality and adherence to ARC and study-specific protocols as well as timelines. The position requires a detail-oriented individual with an ability to understand complex protocols, obtain appropriate certifications for pulmonary function testing (PFT), and maintain research records, adhere to time-lines and disseminate information to subjects, peers, and managers.

PRINCIPAL DUTIES AND RESPONSIBILITIES

. Develops and plans the implementation of procedures for research studies evaluating asthma treatments and medications.

2. Actively responsible for the recruitment of study subjects for ARC and own studies. This includes developing and implementation of recruitment strategies, telephone screening of potential subjects, enlisting participation by scheduling appointments and sending out necessary paperwork.

3. Performing study visits, including administration of consent, performing PFT, following ARC procedures for study visits, and appropriate follow up with subjects.

4. Collects and reviews study data, ensuring compliance with protocol and data integrity.

5. Oversees administrative aspects of trials, including data quality, protocol violation reporting and adverse event reporting.

6. Serves as the primary contact for assigned projects for both internal and external communications (including preparing for Monitor site visits). Directly responds to inquiries regarding study protocol and policy.

7. Develops and prepares content for study IRB submissions.

8. Prepares and presents weekly data reports for meetings, departmental managers, and study monitors.

9. Trains and educates peers on study procedures.

10. All other duties as assigned.

Requirements

QUALIFICATIONS

BS required, MS/MPH or health related degree with at least 5 years experience in conducting clinical trials is preferred. Individuals with extensive clinical trials experience without an advanced degree will be considered.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED

Strong organizational and communication skills.

Clinical experience in performing pulmonary function testing and general clinical procedures (such as spirometry, methacholine challenges, sputum inductions, exercise physiology, allergy skin testing, blood drawing, vital signs) preferred.

Strong analytical and computer skills required, proficiency with Microsoft Access, Excel, Word and Outlook.

Effective problem solving skills.

WORKING CONDITIONS

Will work 100% of the time in the Asthma Research Center, this includes the Research Office and the Research Lab where subject testing is completed. The office is shared with several other staff (e.g., Study Coordinators and Project Managers). Specific workspace will be assigned in the Research Office and includes sharing of general space with other staff.

Shift

Day Shift

EEO Statement

An EEO, AA, VEVRAA Employer