1+ months

Clinical Study Coordinator

Kelly Services
Garden Grove, CA 92841
**Clinical Study Coordinator** - Garden Grove or Long Beach

**Job Summary:**

The Study Coordinator is responsible for coordinating clinical research studies conducted by principal investigator(s) in a variety of complex activities involved in the collection, compilation, documentation and collection of clinical research data under the direct supervision of the Principal Investigator.

Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory policies and procedures.

The Research Coordinator/Nurse oversees and coordinates the daily activities of clinical research studies; this includes but is not limited to study start- up activities, creating source documentation, obtaining informed consent, educating participants on the details of the research study, facilitating participant care and follow-up per protocol and completing CRF/eCRF per protocol guidelines.

Arrange and facilitate the coordination of company departments necessary for protocol execution.

**Responsibilities and Essential Duties**


+ Develop relationship with sponsors, CROs, monitors, investigators and Staff. Maintain relationship in a professional and educational manner.

**Pre-Study and Pipeline:**

+ Determine feasibility of company facility to conduct the study in accordance to protocol requirements.

+ Arrange and facilitate the coordination of departments for protocol execution.

+ Collect clinic demographics and complete site questionnaires for pipeline studies.

**Post Site-Selection Activity:**

+ Develop individual recruitment strategy for each study based on addressing the unique challenges identified for patient recruitment and formalize a recruitment plan collaboratively with study team and investigator(s).

+ Participates in required training and education programs.

+ Responsible for education of clinic staff regarding clinical research.

+ Provide guidance to ancillary personnel involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel.

+ Coordinate the development of forms, questionnaires and the application of research techniques; assist in writing procedures manuals for data collection and coding.

+ Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.

**Study Execution:**

+ Lead patient identification efforts by active screening activities from investigator(s) clinics, hospital, referral networks, marketing, etc.

+ Screens potential patients for protocol eligibility.

+ Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls/randomizes patients on protocol.

+ Coordinates patient care in compliance with protocol requirements.

+ Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA, FDA, and ICH.

+ Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

+ In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.

+ May disburse investigational drug and provide patient teaching regarding administration.

+ Coordinates and maintains investigational drug accountability.

+ Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis.

+ Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.

+ Responsible for accurate and timely data collection, documentation, entry, and reporting.

+ Schedules and participates in monitoring and auditing activities.

+ Cooperate and assist with monitor for monitoring visits by answering questions, providing requested materials, and answering queries to complete resolution.

+ Evaluate and interpret collected clinical data in conjunction with principal investigator(s) as appropriate; prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions.

+ Confer with principal investigator(s) to assist in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication.

**Minimum Qualifications**


+ Education: BS or MS degree in the life sciences or psychology field required.

+ BS with 5 years experience or MS with 3 years clinical research experience managing projects individually and within a group setting.

+ Superior interpersonal, people management and communication skills.

+ Strong technical expertise with Microsoft Office products (particularly Word, Outlook and PowerPoint), and Windows XP are essential. Experience using a customer relationship management database is preferable. Knowledge of web-based technologies and experience using content management systems are mandatory.


+ Minimum of 2 years experience in Phase I Phase III drug and/or device studies.

+ Strong project management, analytical, organizational and problem solving skill

+ Understanding of ICH and GCP regulations.

**Specialized Skills:**

+ Demonstrated ability to work on deadlines, set priorities and juggle multiple projects without compromising quality.

+ Superior interpersonal, people management and communication skills.

+ Strong technical expertise with Microsoft Office products (particularly Word, Outlook and PowerPoint), and Windows XP are essential. Experience using a customer relationship management database is preferable. Knowledge of web-based technologies and experience using content management systems are mandatory

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at


Posted: 2019-11-29 Expires: 2020-04-18

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Clinical Study Coordinator

Kelly Services
Garden Grove, CA 92841

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