Clinical Research Coordinator Associate

Overview

Clinical Research Coordinator Associate (1 Year Fixed-Term)

Department:
School of Medicine, Redwood City, California, United States. The Department of Orthopaedic Surgery conducts musculoskeletal research across subspecialties and aims to advance treatments for musculoskeletal injury and disease. The CRCA will oversee clinical studies within the PMR/Lifestyle Medicine division, working under supervision and collaborating with coordinators, research assistants, physicians, scientists, biostatisticians, residents, and medical assistants involved in spinal care research.

The role requires strong communication and documentation skills and the ability to juggle competing project priorities and deadlines.

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and obtain 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, 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 (PI) regularly, ensuring patient safety and adherence to proper study conduct.
• Clearly communicate to PI and research team regarding project status and any issues/barriers to project implementation.
• Interact with lead biostatistician regularly, ensuring proper study implementation and data management.
• Meet with PI and research manager regularly to refine project prioritization.
• Juggle multiple open research projects while meeting deadlines for deliverables.
• Respond to team communications (email, phone) in a timely and accurate manner.
• 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.
• Conduct scientific and educational writing collaborating with the PI and researchers to research, develop, and disseminate evidence-based resources for both professional and lay audiences.
• Other duties may also be assigned.

Education & Experience (required)

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

(required)

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.
• Skills in scientific/health education writing are valued but not required.

Desired Qualifications

• Excellent verbal and written communication skills in English required.
• Prior experience with patients or research subjects is desired.

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

• 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 up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects weighing more than 40 pounds.
• Reasonable accommodation will be provided as required by law.

Occasional evening and weekend hours.

The expected pay range for this position is $34.56 to $40.30 per hour.…