Clinical Research Coordinator Associate (24-Month Fixed-Term)

Responsibilities

• Prepare initial study documents for IRB submission in compliance with all local, state and federal regulations.
• Advise the IRB of amendment changes to the protocol and complete annual protocol renewals.
• Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines.
• Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations.
• Participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies.
• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coverage of studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.
• Aid in the development of recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.
• Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
• Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Maintain drug accountability, adequate study supplies and equipment.
• Oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject’s medical record.
• Report all serious adverse events promptly to investigators, sponsors and the IRB.
• Protect the rights, safety and well-being of human subjects involved in the clinical trials.

Qualifications

• Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Physical Requirements

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.