Part -Time Clinical Research Coordinator

About the role

Optum NY/NJ is seeking a Part-Time Clinical Research Coordinator to support oncology care teams and guide patients through clinical research activities.

Responsibilities

• Comprehend study protocols and ensure all procedures and assessments (including screening and end of treatment) are carried out per protocol specifications.
• Collect and document accurate and verifiable data.
• Maintain protocol, GCP, ICH compliance.
• Adhere to organizational SOPs.
• Be present at all required study visits to assist the investigator with adherence to the protocol and collect all data for visit.
• Absorb and assist in scheduling the study procedures and appointments (scans, EKGs, labs, any outside exams).
• Absorb and assist in carrying out administrative procedures for the consent, enrolling and randomization process.
• Prepare, process, and ship laboratory specimens as required per protocol.
• Complete study synopsis notes and enter data into the study-specified database, electronic data capture (EDC).
• Collect complete medical and disease history via chart review and patient interview.
• Collect current medication list, subject health information, and occurrence of adverse events.
• Plan the subject calendar in advance for cycles and visits based on the schedule of assessments, including ability to efficiently manage your and the subject's time, and to think ahead for the next visit.
• Absorb and assist in the provision and collection of study medications and performing drug accountability.
• Participate in monitor visits as needed.
• Prescreen EMRs for potential patients to enroll in studies.
• Communicate effectively with physicians, multi-disciplinary teams, patients, sponsors, CROs, and other team members.
• Prepare and be available for monthly recruitment calls with sponsors regarding prescreening updates, patient enrollment projections, barriers to recruitment, elaborate on inclusion/exclusion criteria difficult to meet, etc.
• Prepare and be responsible for database locks that occur every 3 months for all active studies. Turnaround time is within 24 hours to respond to urgent emails.
• Attend investigator meetings for all active studies.
• Performs other duties as assigned.

Qualifications

• High School Diploma/GED
• 1+ years of clinical research experience
• 1+ years of knowledge of GCP (good clinical practice)
• 1+ years of knowledge of clinical data entry
• 1+ years of computer proficiency experience with Microsoft Office (Word, Excel, and Outlook) and be able to access multiple web applications
• Ability to travel to the locations below: 90 South Bedford Road, Mount Kisco, 10549, 30 Columbia Street Poughkeepsie, NY 12601, 600 Westage Business Center Drive, Fishkill, NY 12524, 1400 Old Country road, Westbury, NY 11590 (One to two times a month)
• Ability to travel 100% of the time and have reliable transportation, with a current and non-restricted state of New York's Driver's License and State-required insurance
• Access to a designated quiet workspace in your home (separated from non-workspace areas) with the ability to secure Protected Health Information (PHI)
• Live in a location that can receive a UnitedHealth Group approved high-speed internet connection or leverage an existing high-speed internet service
• Reside within a commutable distance to Westchester County, NY and surrounding communities

Preferred Qualifications

• Knowledge of oncology medical terminology

Soft Skills

• Ability to work independently and maintain good judgment and accountability
• Demonstrated ability to work well with health care team
• Strong organizational and time management skills
• Ability to multi-task and prioritize tasks to meet all deadlines
• Ability to work well under pressure in a fast-paced environment
• Excellent verbal and written communication skills; ability to speak clearly and concisely, conveying information in a manner that others can understand, as well as ability to understand and interpret information from others