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Research Study Coordinator

Siyan Clinical Research


Location:
Santa Rosa, California
Date:
07/12/2017
2017-07-122017-08-11
Job Status:
Full Time
Categories:
  • Clinical Operations
Siyan Clinical Research
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  • Research Salary

Job Details

Siyan Clinical Research is a leading psychiatric clinical research center in Northern California. We have an immediate opening for a Part time/Full time Study Coordinator. The Study Coordinator is responsible for supporting clinical research conducted by principal investigator. Assisting in project assignment and ensures that pre-established work scope, study protocol, state and federal regulatory requirements. This position serves as the principal administrative liaison for assigned clinical trials ensuring adherence to guidelines for the collection of clinical data and/or administration of clinical studies.

Essential duties and responsibilities:

Obtaining informed consent per ICH/GCP guideline and site SOPs.

Interviewing and collecting data from study participants.

Scheduling subject visits.

Obtaining subject vital statistics (including height, weight, BMI, pulse, respiratory rate, blood pressure, etc.) and ECGs.

Dispensing/collecting study medication and providing accurate Investigational Product accountability.

Collecting subject laboratory specimens according to protocol.

Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned.

Maintaining a thorough understanding of all data collection instruments and collecting data accurately according to protocol.

Facilitate weekly meetings and supervise research associates and other staff working on pharmacologic and behavioral studies; provide guidance as a supervisor, conduct regularly scheduled supervisory meetings with direct reports

Oversee, plan for, manage, and problem-solve the data needs including creating and modifying survey instruments, interview guides, and case report forms

Independently manage regulatory affairs of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH) and other funding agency reports

Generate as-needed reports for study team, including reports on recruitment, enrollment, retention, and adverse events

Supervise and manage recruitment; contacting and building working relationships with primary providers in the community

Perform other related duties as required or assigned.

Knowledge:

A body of information needed to perform a task; May be obtained through education, training or experience

Medical and research terminology

Knowledge of federal regulations, good clinical practice (GCP)

Skills:

The proficiency to perform a certain task

Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel

Verbal and written communication skills

Interpersonal skills, detailed -oriented and meticulous

Abilities:

An underlying, enduring trait useful for performing duties

Communicate and work effectively with a diverse team of professionals

Organizational and prioritizing capabilities

Work independently in a fast pace environment with minimal supervision at off-site facilities

Available to work on flexible time

Education:

Minimum Required: High School Diploma

Preferred: Bachelor’s College Degree (4 yr. program)

Experience:

Minimum 1 year experience in Clinical Trial/Research

Minimum 2 years experience in the Healthcare Field

Certification/License:

Preferred:

  • Clinical Medical Assistant (with research experience)
  • RN or LPN
  • Phlebotomy experience and certificate experience.
  • GCP Certification
  • Research Professional Certification-CCRP or exam eligibility certification

Job Benefit:

Competitive Salary : Depending upon educational credentials and experience

Health Insurance

401 K Plan

Vacation, Sick leave and other benefits.

Job Type: Full-time

Required education:

High school or equivalent

Required experience:

Healthcare: 2 years

Clinical Research: 1 year