Asthma Clinical Research Project Manager
Working under the general direction of the Director and supervised by the Lab Manager of the Asthma Research Center (ARC), the Project Manager (PM) develops, executes, and oversees work on several research study protocols funded by the NIH and/or 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 complete protocols and become certified for procedures such as pulmonary function testing (PFT) and related challenges. S/he must be skilled at defining and adhering to time-lines and disseminating appropriate information to subjects, peers, and managers.
Principal Responsibilities:
- Contributes to protocol authorship and plans for the implementation of the specified procedures for research studies evaluating asthma treatments and medications. May draft CRFs and build databases.
- Actively responsible for the recruitment of study subjects for ARC and own studies. This includes development and implementation of recruitment strategies, telephone screening of potential subjects, enlisting participation by scheduling appointments and sending out necessary paperwork.
- Performing study visits, including the administration of consent, performing PFT, following ARC procedures for study visits, and appropriate follow-up with subjects.
- Collects and reviews study data, ensuring compliance with protocol and data integrity. Drafts corrective action plans for any issues identified through QC. Ensures queries are responded to in a timely manner.
- Oversees regulatory aspects of trials, including monitoring or coordinating a monitoring body, safety and protocol violation documentation as appropriate. Develops and prepares content for study IRB/IND amendments and reports. Ensures audit-ready files are kept.
- Serves as the primary contact for assigned project for both internal and external communications. Directly responds to inquiries regarding study protocol and policy. Ensures necessary meetings are held and minutes kept and distributed. Hosts site visits. Negotiates study timelines and keeps team members accountable.
- Develops and finalizes project budgets for baseline establishment, and reports on monthly financial status. May prepare invoices based on study progress.
- Prepares and presents regular and ad-hoc study progress reports for weekly meetings, departmental managers, and study sponsors.
- Trains and educates peers on study procedures. Guides work of others assigned to support projects in a matrix management environment. May author or revise Manual(s) of Operation, and may also contribute to ARC policy and guidance documents.
- All other duties as assigned
Qualifications:
- BS required, MS/MPH or health-related degree and at least three years’ experience in clinical research is preferred. Individuals with extensive clinical trials experience without an advanced degree will be considered.
Skills/Competencies Required:
- Strong organizational and communication skills.
- Experience in a clinical environment.
- Strong analytical and computer skills required proficiency with Microsoft Access, Excel, Word, and Outlook.
- Effective problem solving skills.