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Clinical Research Coordinator

InSite Clinical Research DeSoto, TX

  • Posted: 25 days ago
  • Full-Time
  • Benefits: medical, vision, 401k, dental
Job Description

Job Summary

Coordinates and administers research study associated activities, under the immediate direction of a principal investigator, following Good Clinical Practice (GCP) guidelines in an inpatient/outpatient setting. Assists in project planning, develops and maintains recordkeeping systems and procedures, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Coordinates research subjects, as appropriate, and serves as principle administrative liaison for the project.

Reports To

Reports directly to Principal Investigator, Sub-Investigator, Operations/HR Manager, and Quality Assurance Manager.

Responsibilities and Duties

  • Plans and coordinates the initiation of research study protocol.
  • Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for study protocol.
  • Assist in recruitment process for potential subjects.
  • Instructs and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
  • Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff.
  • Enter collected data into electronic data capture (EDC) systems in a timely manner (generally 24-72 hours).
  • To perform laboratory functions such as vital signs, ECG, blood draw, PK sampling, centrifuge, packing up and shipping out.
  • Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
  • Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
  • Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper voluntary informed consent; tracks subjects’ information from multiple projects.
  • Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
  • Attend investigator meeting(s) as necessary required per protocol.
  • Maintain contact with sponsors to schedule and coordinate site visits.
  • To participate in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.
  • To perform miscellaneous job-related duties as assigned.

Qualifications and Skills

  • Fluent in verbal and written English communication skills.
  • CCRC (ACRP) certification.
  • Applicable Bachelor's Degree (Highly Preferred) or Master's Degree in applicable clinical fields.
  • Understanding of ICH/GCP guidelines for human research (Previous GCP certification preferred).
  • Computer competency including proficiency in Microsoft Word and Excel.
  • Understanding Phases I-IV drug development processes.
  • Experience in psychiatric/central nervous system clinical trials highly preferred.
  • Understanding and knowledge of psychiatric medications.
  • ECG, phlebotomy skills, IV infusion, and any other technical skills (if applicable) related to the completion of a study visit as required by the protocol.

Benefits

  • Medical, Dental, and Vision Insurance
  • Health Reimbursement Arrangement
  • Retirement Plan
  • Employee Assistance Program
  • Paid Time Off & Holidays
  • Life/Accidental Death & Dismemberment and Long Term Disability

EEO Statement

InSite Clinical Research, LLC is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Job Type: Full-time

 

Company Description
InSite Clinical Research has been serving the Dallas-Fort Worth Metrolpex since its establishment in 2004. Dr. Raj Shiwach serves as the Principal Investigator for Phase I, II, III, and IV clinical research trials primarily involving CNS (Central Nervous System) disorders. InSite Clinical Research has an extensive history of successful participation in double-blind placebo controlled clinical trials.

InSite Clinical Research has participated in clinical trials in the following indications: Schizophrenia, Schizoaffective Disorder, Bipolar Mood Disorder, Major Depressive Disorder, Anxiety Disorder, Tardive Dyskinesia, ADHD, Chronic Pain, Migraines, Fibromyalgia, Autism, Alzheimer’s, Diabetes, Smoking Cessation, Insomnia, and Chemical Dependency.

OUR MISSION & VALUES

Insite Clinical Research is committed to the ethical performance of Clinical Research Trials accordance with Good Clinical Practice (GCP) guidelines. Upholding respect for our patients we strive to contribute to furthering more effective drug therapies. Our goal is to provide excellent patient care and the utmost safety. InSite Clinical Research is dedicated to improving the mental health and quality of life for all humankind. We contribute to the advancement of scientific knowledge by conducting high quality clinical research leading to the future treatments and cures of tomorrow.

InSite Clinical Research

InSite Clinical Research has been serving the Dallas-Fort Worth Metrolpex since its establishment in 2004. Dr. Raj Shiwach serves as the Principal Investigator for Phase I, II, III, and IV clinical research trials primarily involving CNS (Central Nervous System) disorders. InSite Clinical Research has an extensive history of successful participation in double-blind placebo controlled clinical trials. InSite Clinical Research has participated in clinical trials in the following indications: Schizophrenia, Schizoaffective Disorder, Bipolar Mood Disorder, Major Depressive Disorder, Anxiety Disorder, Tardive Dyskinesia, ADHD, Chronic Pain, Migraines, Fibromyalgia, Autism, Alzheimer’s, Diabetes, Smoking Cessation, Insomnia, and Chemical Dependency. OUR MISSION & VALUES Insite Clinical Research is committed to the ethical performance of Clinical Research Trials accordance with Good Clinical Practice (GCP) guidelines. Upholding respect for our patients we strive to contribute to furthering more effective drug therapies. Our goal is to provide excellent patient care and the utmost safety. InSite Clinical Research is dedicated to improving the mental health and quality of life for all humankind. We contribute to the advancement of scientific knowledge by conducting high quality clinical research leading to the future treatments and cures of tomorrow.

Address

941 York Dr.

DeSoto, TX
75115 USA

Industry

Healthcare

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