Clinical Research Coordinator - Endocrinology

Clinical Research Coordinator - Endocrinology

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role supports the development of new products and innovation and performs basic, translational, and/or clinical research toward solving a specific problem for an entity or community. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education.

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Our team within the Division of Endocrinology focuses on studies to improve care for people with diabetes, thyroid disorders, and other endocrine conditions through a mix of industry-sponsored and investigator-initiated research studies. The coordinator plays a role in bringing clinical research to life by keeping studies organized and on track—recruiting and meeting with participants, and collecting and managing data.

This position is an excellent opportunity for someone interested in clinical research who is curious, detail-oriented, reliable, and eager to learn in a supportive and fast-paced environment.

• Assists in the recruitment of study participants.
• Completes follow up with study participants in prescribed settings as required.
• Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
• Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the PI, the study sponsor and Institutional Review Board.
• Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
• Performs basic laboratory activities as needed.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
• Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
• Maintains inventory of all study supplies.
• Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient’s record. Verifies information with the physician.
• Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
• Conducts a QC check of completed CRFs prior to submission for data entry.
• Coordinates resolution of all data queries.
• Completes data entry as warranted.
• Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

• Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.
• Basic Life Support (BLS) certification may be required based on specific role requirements.

• Two (2) years in research related activities.
• IATA Hazardous Good Shipping certification.
• CITI Human Research Protection certification.

• Typical clinical and administrative office setting.

• High degree of organizational talents, data collection, and analysis skills.
• Requires meticulous attention to detail.
• Excellent computer skills including word processing.
• Ability to prioritize quickly and appropriately.
• Excellent communication and interpersonal skills.
• Systematic record-keeping.

$44,778.55 – $55,978.47

Entry level

Full-time

Research, Analyst, and Information Technology

Hospitals and Health Care

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