Employment Type:

Full time

Shift:

Description:

Skills needed are RedCap and iMedidata (Rave). Experience with SWOG, ECOG-ACRIN, Alliance and NRG (Hybrid Remote)

Please only apply with :

Skills needed are RedCap and iMedidata (Rave). Experience with SWOG, ECOG-ACRIN, Alliance and NRG (Hybrid Remote)

POSITION PURPOSE

Manage a portfolio of investigator-initiated research projects. Projects include some multi-center clinical trials, retrospective studies, and observational studies. Project managers provide oversight and management of the project team in coordination with study principal investigators and the Director to move the project forward efficiently and according to good clinical practice (GCP) guidelines.

ESSENTIAL FUNCTIONS

1. Communicate with principal investigators, the Director, and the department team while maintaining positive and cooperative relationships in day-to-day interactions

2. Maintain research project timelines and manage timely execution of deliverables by the research team

3. Coordinate and attend research investigator and coordinator meetings and teleconferences, including preparing agendas and taking minutes

4. Create and update research study manual of operations and standard data collection procedures for all participating clinical research sites

5. Participate in the development of research study protocols, and create study-specific informed consent document templates

6. Assist with design of electronic case report forms (CRFs), research database validation and variables for data entry, as well as implementing best practices for data capture

7. Maintain study master files, and manage the research study progress in relation to project timelines

8. Monitor studies for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms

9. Prepare and maintain all IRB submissions and continuing reviews

MINIMUM QUALIFICATIONS

Experience:

• At least 3 years’ experience in clinical research, preferably as a project manager required.

• Proficient in electronic data capture systems, i.e., REDCap desired.

• Familiarity with the management of datasets, best practices for data security and management and with creation/maintenance of data dictionaries/code books desired.

• Familiarity with the content and processing of large sampled datasets from the Agency for Healthcare Research and Quality (AHRQ), including the National Inpatient Sample (NIS), National Readmission Database (NRD), etc. preferred.

• Understanding of statistical concepts which will be used for data management purposes preferred. Experiences in health services research preferred.

Education:

• Academic knowledge in a health science discipline that is generally associated with a bachelor’s degree.

Licensure/Certification:

• Certification as Clinical Research Associate or the equivalent is preferred.

Our Commitment to Diversity and Inclusion

Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.

Our Commitment to Diversity and Inclusion

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.

EOE including disability/veteran