Clinical Research Coordinator

1 month ago

Yonkers, United States Actalent Full time

Onsite Oncology Clinical Research Coordinator Opportunity

Description:

Coordinates the initiation and activation of all new clinical trial protocols.

+ Coordinates the preparation of study tools including but not limited to study binders, medication diaries, eligibility checklists and flow sheets (as required).

+ Using Oncore®/Excel ®/Word, develops study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets (as required). In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patients' charts and medical history to confirm protocol eligibility and obtains source documents (i.e. medical record documentation) as needed.

+ Under the direction of the RNC and/or physician, ensures that IRB approved informed consent form has been obtained, signed, placed in the medical record, and that a copy was provided to the patient.

+ Maintains research record (e.g. patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled into studies

+ In collaboration with the RNC and physician, assists with grading adverse events using the most recent version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales. Completes Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines.

+ Ensures research record (e.g. patient consent, eligibility, CRFs, registration confirmation, corresponding source documents, etc.) is maintained for all patients enrolled

+ Using Oncore®, provides regular reports to the tumor study group members and Principal Investigator on all studies to which he/she is assigned.

+ Understands and anticipates needs of study sponsors. Serves as study liaison with study sponsors, schedules monitoring visits and conference calls. Provides accurate, timely, intelligent responses to sponsors' queries.

Additional Skills & Qualifications:

Bachelors Degree Minimum

1-3 years of clinical research experience - recruiting patients, data collection/data entry - well rounded

2+ years of oncology experience

Experience working in multiple EDC systems (Medidata and Inform highly preferred - this person will be working on multiple systems)

+ Robust background in data management (60% of this job is data management/coordination)

+ Experience recruiting, screening, consenting patients for clinical trials (40 % of the job will be this working in the Clinic)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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