Clinical Research Associate 2

SUNY Upstate Medical University • Syracuse, NY

82d • $65,000 - $80,000

About The Position

The Clinical Research Associate II (CRA II) will join a team of experienced coordinators and manage various research trials, including first in human through phase 3 trials. The role will be expected to manage 4 or more studies simultaneously. The CRA II will ensure compliance with FDA guidelines and follow GCP for all managed studies. The CRA II will interact daily with clinicians, sponsors, IRB, regulatory agencies and other research professionals. This is a subject / patient facing role, the candidate needs the ability to communicate directly with study volunteers, collecting detailed clinical information and communicating that to the study team. The CRA II will be responsible for all aspects of the trial conduct including; IRB submission, regulatory documents, training staff, overseeing enrollment of appropriate study subjects, creation and completion of source documents, database entry and query resolution. This position will be the point person on assigned clinical trials and flexible availability is expected. This role is also the key contact for study sponsors / collaborators; therefore, a high level of professionalism and communication skills are required. This role will be expected to maintain a national certification (SoCRA or ACRP).

Requirements

• A Bachelor's degree and 3 years related experience or equivalent combination of education and experience.
• Ability to function in a professional environment with high attention to detail.
• Exemplary communication and organizational skills.
• Fluent with Microsoft Office products including Excel.
• Experience with clinical documentation and HIPAA guidelines.

Nice To Haves

• Clinical Research Associate Certification (SOCRA or ACRP) OR eligibility to sit for exam for certification.
• Clinical skills including phlebotomy.
• Ability to take and record accurate vital signs.
• Obtain EKG tracings and general medical terminology.

Responsibilities

• Manage various research trials, including first in human through phase 3 trials.
• Ensure compliance with FDA guidelines and follow GCP for all managed studies.
• Interact daily with clinicians, sponsors, IRB, regulatory agencies and other research professionals.
• Communicate directly with study volunteers, collecting detailed clinical information.
• Responsible for all aspects of trial conduct including IRB submission and regulatory documents.
• Train staff and oversee enrollment of appropriate study subjects.
• Create and complete source documents, database entry and query resolution.
• Act as the point person on assigned clinical trials.
• Maintain a high level of professionalism and communication skills.

What This Job Offers

• Job Type: Full-time
• Industry: Hospitals
• Education Level: Bachelor's degree