Clinical Research Coordinator

Urology Associates of Central California has a robust and rapidly expanding research department that is seeking an experienced Clinical Research Coordinator. This is a full-time position. If you are ambitious, adaptive, great at multitasking with a strong attention to detail this may be the role for you. We are looking for a dynamic team player to join our team and help us grow our research department.

The Research Coordinator is responsible for coordinating the day-to-day activities of research protocols. This position ensures accurate data collection, documentation, organization, and safety of research participants in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practice (GCP) and Site Standard Operating Procedures (SOPs).

KNOWLEDGE, SKILLS, AND ABILITIES (REQUIRED):

· Strong critical thinking and follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

· Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations.

· Ability to work well independently as well as in a team environment.

· Strong interpersonal, customer service, and multi-tasking skills are critical.

· Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in a research environment or have a willingness to learn and demonstrate proficiency within six months of hire.

· Ability to be flexible, organized, detail-oriented and tenacious in follow-through.

· Possess the ability to work well under pressure, multi-task and manage deadlines.

· Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.

· Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.

· Be knowledgeable of the Sponsor’s protocol so that all activities are completed accurately and completely.

· Ability to exercise sound judgment in set priorities with a strong attention to detail

· At least 2 years of clinical research coordinating experience

· Ability to execute all clinical research activities with moderate supervision

· Ability to adhere to IRB approved protocols

· Participate in the informed consent process of study subjects

· Support the safety of clinical research patients/research participants

· Coordinate protocol related research procedures, study visits, and follow-up care

· Screen, recruit and enroll patients/research participants

· Maintain study source documentation

· Report adverse events

· Phlebotomy experience preferred

This position is M-F, no weekends. We offer health insurance, life insurance, dental insurance, vision insurance, 401k, paid vacation and sick leave, and holiday pay

Clinical Research Assistant

Urology Associates of Central California has a robust and rapidly expanding research department that is seeking a Clinical Research Assistant. This is a full-time position. If you are ambitious, adaptive, great at multitasking with a strong attention to detail this may be the role for you. We are looking for a dynamic team player to join our team and help us grow our research department.

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects.</p>

As a clinical research assistant, responsibilities include preparing and processing lab samples, assisting in screening patients, taking biological samples or vital signs, and organizing data. Your job is to assist the researchers in any way possible, helping them conduct sound, ethical, and scientifically accurate research in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practice (GCP) and Site Standard Operating Procedures (SOPs).

Qualifications and Responsibilities

Assist with screening participants for study eligibility & enroll with accuracy in various databases.

Assist with scheduling of subject appointments in accordance with the protocol and call subjects with study reminders.

Understand protocol structure and how to interpret study requirements to assess study compliance and ensure quality control.

Complete simple to moderately complex data collection tasks and understand and follow proper documentation techniques.

May help maintain study supplies, lab kits, and reorder as needed.

Accurately and effectively draw blood as required by the protocol.

Processes blood samples in accordance with research protocols, fully labels them, and stores them properly per protocol instructions.

Packages and prepares samples for shipping to designated central laboratories.

Assists physicians and nurses in the evaluation of the patient.

Prepares patients for office visits.

Performs phlebotomy and EKG, documents vital signs and other tasks as needed.

Assists all Clinical Research Coordinator in facilitating Good Clinical Practice (GCP) and compliance and clinical patient care.

Strong critical thinking and follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.

Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations.

Ability to work well independently as well as in a team environment.

Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in a research environment or have a willingness to learn and demonstrate proficiency within six months of hire.

Possess the ability to work well under pressure, multi-task and manage deadlines.

Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures. Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.

Be knowledgeable of the Sponsor’s protocol so that all activities are completed accurately and completely.

This position is M-F, no weekends. We offer health insurance, life insurance, dental insurance, vision insurance, 401k, paid vacation and sick leave, and holiday pay

Please Contact Kristin Santeufemia @ 559-321-2924

Email: KSanteufemia@urologyassociates.net

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