Employment Type:

Full time

Shift:

Day Shift

Description:

This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with cardiology clinical trials and industry sponsored studies preferred.

• Assist in the recruitment of study participants.

• Screen patient charts to identify eligible study patients.

• Review all prospective protocol patients' charts to evaluate protocol eligibility, advise investigators of needed tests to complete pre-treatment work-up.

• Assist in coordinating the collection of all protocol required laboratory testing (i.e. blood, bone marrow, urine, etc.) Extract data from study participants source documents.

• Assist the investigators in evaluating, documenting, and reporting adverse events and other safety related data.

• Conduct telephone screening calls for patients inquiring about their participation in clinical trials. Interact and educate patients and families to help them gain an understanding and alleviate anyapprehension regarding the studies.

• Obtain written informed consent from patient allowing for free expression of fears, questions, etc., to ensure patient understanding.

• Ensure the accuracy and completeness of site regulatory documentation including but not limited to IRB and FDA approvals and reports, and adverse event documentation.

• Participate in site initiation, monitoring and close out visits.

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