Clinical Research Coordinator Associate (12-Month Fixed-Term)

Stanford Reglab; California; On-site; USD 54,000 - 78,000; Full time

Job summary

Stanford University’s Department of Obstetrics & Gynecology is seeking a Clinical Research Coordinator Associate (CRCA) to support a variety of women’s health clinical research studies. The CRCA will coordinate moderately complex aspects of one or more studies under close supervision of the clinical research manager and/or principal investigator.

Experience working with diverse populations is preferred, and familiarity with regulatory requirements and good clinical practice is a plus.

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.
• Experience working with diverse populations is preferred.
• Knowledge of regulatory requirements and good clinical practice (GCP) is a plus.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies; coordinate studies from start-up through closeout.
• Determine eligibility and obtain consent from participants according to protocol; assist in recruitment.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data; manage study databases and study documents.
• Ensure compliance with protocols; prepare regulatory submissions and ensure IRB renewals are completed.
• Assemble study kits, monitor scheduling of procedures and charges, and attend sponsor meetings as primary contact.
• Monitor expenditures and adherence to study budgets; resolve billing issues with finance/management staff.
• Interact with the principal investigator to ensure patient safety and proper study conduct.
• Ensure essential documentation and recording of data per regulatory requirements.
• Participate in monitor visits and regulatory audits.

Skills

Interpersonal skills

Microsoft Office

Medical terminology

Education

Two-year college degree / Bachelor's degree

Job description

Stanford University's Department of Obstetrics & Gynecology is seeking a Clinical Research Coordinator Associate (CRCA) to support variety of women's health clinical research studies. CRCA joining the team is expected to coordinate moderately complex aspects of one or more clinical studies under close direction of clinical research manager and/or the principal investigator. Experience working with diverse populations is preferred. More details about the department at obgyn.stanford.edu.

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.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS

Occasional evening and weekend hours.

WORK STANDARDS

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.

Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.
• Ability to drive day or night.
• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

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.

Minimum Education and 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.

Certificates and Licenses Required

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