Assistant Clinical Research Coordinator
Location: San Antonio, TX, USA
Notice
Requisition Number: 3259
Position Title: Assistant Clinical Research Coordinator
External Description:
SUMMARY: The Assistant Clinical Research Coordinator, under the general supervision and guidance of the Senior Manager, Study Conduct, is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines.
RESPONSIBILITIES:
Tasks may include but are not limited to:
• Always represents Worldwide Clinical Trials Early Phase Services (WCTEPS) in a professional manner (verbal, written and in appearance) when interacting with Sponsors, subjects, outside vendors and fellow employees.
• Reviews study protocol for studies as assigned.
• Attends study initiation visits for their studies.
• During involvement in trial, helps assure source documents for the trial are accurate and thorough.
• Performs data transcription and maintenance of paper study and source documents .
• Performs quality checks on source documents specific to the study
• Responsible for scheduling clinical lab repeat orders.
• Assists the Coordinator with the management of the trial from phone screening to end of study.
• Prepares for study check-in by reviewing study specific documents, preparing check-in supplies, and dorm rooms.
• Attends logistics meetings to review study-related procedures, staffing, and visit flow for assigned studies.
• Serves as the back-up contact for subjects by answering questions or addressing concerns and contacts subjects for study changes as required.
• Covers subject visits (i.e. outpatient visits, check-ins, check-outs, and dose qualifications) as assigned.
• Obtains and documents adverse event data on appropriate source documents.
• Responsible for tracking infractions to In-House Facility Rules.
• Works with the Coordinator in submitting subject payment request.
• Assists with preparing rooms for Monitoring visits.
• Assists with query resolution.
• Helps the Coordinator prepare study documents for long-term storage.
• Complies with in-house documentation requirements.
• Follows Worldwide Clinical Trials Drug Early Phase Services (WCTEPS) safety guidelines.
• Identifies study conduct risk and reports them to his/her Supervisor .
• Responsible for completing all necessary training for their position, including SOPs and WIs.
• Responsible for requesting, scheduling, and attending any training required for this position.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
• Strong interpersonal and communication skills.
• Ability to understand written and oral instructions.
• Basic computer knowledge and applications required for generation of business correspondence and preparation of regulatory and other study documents.
• Excellent attention to detail and organizational skills.
• Ability to meet deadlines with high quality work.
• Knowledge of the clinical research process, including Good Clinical Practices.
• Possible equipment includes, but is not limited to; computers, rolling carts, fax machine, photocopier, telephone, spirometry, allergy testing equipment, scales, calculators, vital signs equipment, ECG machines.
REQUIREMENTS:
Required: High School or GED Diploma
Preferred: Six months of experience in clinical research performing data transcription, source review / maintenance and query resolution.
City:
State: Texas
Employment Type: Regular
Community / Marketing Title: Assistant 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.