Description:

JOB PURPOSE:

Perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or study coordinator/supervisor

CORE DUTIES:

Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing 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.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
Requirements:

MINIMUM REQUIREMENTS:

Education & Experience:

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.

Knowledge, Skills and Abilities:

Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
Certifications and Licenses:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

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.

Ability to drive day or night, if applicable.

Notes:

Hybrid 3-4 days onsite per week