Assistant Clinical Research Coordinator
Location: San Antonio, Texas, United States
Requisition Number: 3343
Position Title: Assistant Clinical Research Coordinator
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.
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.
Required: High School or GED Diploma
Preferred: Six months of experience in clinical research performing data transcription, source review / maintenance and query resolution.
Other: Possible mental demands include, but are not limited to; reading, math, intense concentration, verbal communication, written communication, client contact, attention to detail, multiple tasks, frequent interruptions, fluctuation in workload.
Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids.
Workloads will be assigned. There will be times when an adjustment in work hours to include weekends is necessary. They must work closely with the Coordinator and Research Associate to assure a study is conducted within GCP guidelines. Must be able to follow written and verbal communication. Must be punctual.
The Assistant Clinical Research Coordinator will be the back-up contact for the study subjects, as well as the Sponsor. He/she must be available for daily communication with study subjects and Sponsor representatives as per the demands for successful enrollment of a clinical research trial as well as the safety of the subjects. They will be responsible for communicating problems, questions and/or clarifications to the Coordinator and Research Associate. As subject screening and enrollment occur, the Assistant Coordinator will work with the Coordinator, Investigator(s) and the Senior Manager, Study Conduct as often as necessary for successful completion of the trial.
Employment Type: Regular
Community / Marketing Title: Assistant Clinical Research Coordinator
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 Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.