Clinical Research Coordinator

Requisition Number: 3508

Position Title: Clinical Research Coordinator 1

External Description:

Summary:  The Clinical Research Coordinator is responsible for assuring that the integrity and quality of all assigned phase 1 clinical research trials are maintained and that the trials are conducted in accordance with Good Clinical Practice guidelines and ICH guidelines as applicable. 

Responsibilities:

Tasks may include but are not limited to:

• Reviews study protocol.
• Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits by Monitors or Sponsor representatives.
• Performs quality checks on source documents specific to the study.
• Reviews approved regulatory documents from the IRB/IEC.
• Attends in-house protocol meetings to review study-related procedures, staffing, and visit flow.
• Schedules medical coverage for physicals, dosing, etc.
• Coordinates the trial from phone screening through study completion.
• Uses experience to schedule study procedures so they are efficient and timely for all involved while maintaining study integrity.
• Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose.
• Maintains and documents communication with Sponsor or Sponsor representative(s) throughout the clinical trial.
• Responsible for giving subject instructions at check-in and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
• Ensures randomization procedures are completed per study requirement.
• Obtains and documents adverse event data on appropriate forms.
• Assures quality and completeness of source documents and Case Report Forms (CRFs) collected during the course of the study.
• Assists with monitoring visits on-site and available during visits for correction, questions, etc.
• After close-out visit has been conducted, prepares study documents for archiving, according to timelines.
• Responsible for completing all necessary training for the position, including WIs and SOPs.
• Helps train new Coordinators, Assistant Clinical Research Coordinators, and Research Associates by serving as a mentor.

 

OTHER SKILLS AND ABILITIES:

• Excellent written and oral communication skills. 
• Ability to understand complex written and oral instructions. 
• Basic computer knowledge and applications required for the generation of business correspondence and preparation of regulatory and other study documents. 
• Strong interpersonal skills. 
• Excellent attention to detail. 
• Exceptional organizational skills. 
• Ability to set and meet deadlines with high-quality work.
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.
• Possible equipment includes, but is not limited to:  computers, rolling carts, fax machine, photocopier, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, allergy testing equipment, scales, microscope, calculators, vital signs equipment, and ECG machines

REQUIREMENTS:

• Bachelor’s Degree (preferably in the field of Life Sciences or Health)
• Excellent attention to detail. 
• Exceptional organizational skills. 
• Ability to set and meet deadlines with high-quality work.
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.

Preferred Requirement: 0-2 years of clinical research experience

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Research Coordinator

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.