Research Associate/ Project Manager - Clinical Assay Development

Employment Type:

Full time

Shift:

Description:

Manage a portfolio of scientific director-initiated research and development projects, and assist with the conduct of research and assay development at Warde Medical Laboratory. Projects include clinical assay development and validation in toxicology, chemistry and hormone measurement. Clinical Assay Development Research Project Manager provides oversight and management of the project team in coordination with study scientific directors and the administrative director in order to move the project forward efficiently and according to CLIA, NYSDOH and FDA requirements. The position requires an individual who can manage multiple projects, prioritize competing deadlines, and who is energized by working in a dynamic research environment.

Location: Warde Lab, Ann Arbor

40 hours a week

POSITION PURPOSE

Manage a portfolio of scientific director-initiated research and development projects, and assist with the conduct of research and assay development at Warde Medical Laboratory. Projects include clinical assay development and validation in toxicology, chemistry and hormone measurement. Clinical Assay Development Research Project Manager provides oversight and management of the project team in coordination with study scientific directors and the administrative director in order to move the project forward efficiently and according to CLIA, NYSDOH and FDA requirements. The position requires an individual who can manage multiple projects, prioritize competing deadlines, and who is energized by working in a dynamic research environment.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Conducts routine and non-routine lab procedures and experiments for toxicology, chemistry, and molecular clinical test development. This includes the conduct of relevant preliminary experiments and analytical validation experiments, applying basic scientific principles. As needed, is assigned to supports development and validation of new technologies for toxicology, chemistry or molecular assays. Documents and maintains detailed and precise records of the validation experiments performed. Communicate with scientific and administrative directors, and the department team while maintaining positive and cooperative relationships in day-to-day interactions; Maintain research project timelines and manage timely execution of deliverables by the research team; Maintain study master files, and manage the research study progress in relation to project timelines Coordinate and attend research investigator and coordinator meetings and teleconferences, including preparing agendas and taking minutes; Monitor studies for compliance with CLIA, NYSDOH CLEP, and FDA guidelines, including completion of regulatory documents and proper completion validation packets; Serve as a resource to the scientific directors team, working across departments to drive project progress and completion; Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participate in their resolution. Maintains the confidentiality of information acquired pertaining to patient, physicians, colleagues, and visitors to Warde Medical Laboratory. Discusses patient and hospital information only among appropriate personnel in appropriately private places. Behaves in accordance with the Code of Conduct, Service Excellence Standards, and the Mission, Vision and Values of SJMH. Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.

OTHER FUNCTIONS AND RESPONSIBILITIES

Performs other duties as assigned.

REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE

Education:

Minimum: Bachelor's degree in Chemistry, Medical Technology, or related STEM e.g.; (Biology, Chemistry, Biochemistry, biomedical engineering).

Preferred: Advanced degree, e.g.; MS, PhD, MBA or previous work experience that demonstrates an understanding of test or assay development in a clinical laboratory.

Experience:

Minimum: Three years of full-time experience as a medical laboratory scientist or technical specialist with experience in clinical assay development setting, or equivalent

Preferred: Technical experience in chemistry, specifically HPLC and/or mass spectrometry techniques. Two years of formal operations leadership experience overseeing progressively complex projects and interfacing with development teams

Certification/Licensure: Certification as a research associate, project manager or the equivalent is desirable.

REQUIRED SKILLS AND ABILITIES

Able to multi-task and manage competing priorities across multiple projects effectively; Excellent interpersonal, oral, and written communication skills with exceptional attention to detail; Ability to participate in new experimental designs, plan and conduct laboratory experiments, assemble and interpret data. Ability to exercise critical thinking to provide feedback on experimental design and experimental approaches to assay development. Experience with laboratory information management system (LIMS) is preferred. Strong skills in standard Office applications including Excel, preferred MS Project or equivalent. Ability to aggregate, sort, arrange, and present data and information in a logical meaningful way for discussion by others. Ability to use other software required to perform essential functions. To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance Portability and Accountability Act (HIPAA) and Trinity Health's Confidentiality of Information Standards, as well as other regulatory entities, individuals employed in this position will be granted systems and information access as appropriate for this position.

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