Clinical Research Coordinator
Location: San Antonio, Texas, United States
Requisition Number: 3438
Position Title: Clinical Research Coordinator 1
SUMMARY: The Clinical Research Coordinator 1, under the guidance of the Senior Coordinator Group Manager, and each clinical trial’s Principal Investigator, 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 and ICH guidelines as applicable. The Clinical Research Coordinator 1 works under the general supervision and guidance of the Senior Coordinator Group Manager.
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 interacts with sponsors, subjects, outside vendors and fellow employees.
- 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 meeting 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.
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:
- Excellent written and oral communication skills.
- Ability to understand complex written and oral instructions.
- Basic computer knowledge and applications required for 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.
Required: Bachelor’s Degree (preferably in the field of Life Sciences or Health) or 1-2 years of clinical research experience.
Preferred: 2 to 5 years of clinical research experience.
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, and fluctuation in work load.
Possible physical demands include, but are not limited to: occasional 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; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; and exposure risk to potentially infectious blood and/or body fluids, fumes or chemicals.
The Clinical Research Coordinator 1 is independently responsible for planning his/her workload and time required for the successful recruitment of volunteers who are eligible according to protocol inclusion and exclusion criteria. There will be times when an adjustment in work hours, to include weekends, is necessary. The responsibility will be inclusive of the timeline required for successful enrollment of a clinical trial. Timelines will be dependent upon the length of the study, the length of time prior to study recruitment and length of time for study conclusion.
The Clinical Research Coordinator 1 is responsible for the workload assigned to him/her as the Senior Coordinator Group Manager deems necessary. Workload will be assessed by difficulty of protocol enrollment, length of clinical trial and quantity of clinical trials currently assigned to the Clinical Research Coordinator 1. The Clinical Research Coordinator 1 is responsible for ongoing communications with the Senior Coordinator Group Manager, Project Manager and the Principal Investigator to ensure that timelines of assigned projects are met and that the integrity and quality of the clinical trial is maintained. Must be able to follow written and verbal communication. Must be punctual.
The Clinical Research Coordinator 1 will be the primary contact for the study subjects, as well as site staff. He/she must be available for daily communication as per the demands for successful enrollment of a clinical research trial as well as the safety of the subjects.
The Clinical Research Coordinator 1 is responsible for communicating problems, questions and/or clarifications. These communications can include, but are not limited to, proper dispensing of test article, test article accountability, protocol clarifications, protocol deviations, scheduling of monitoring visits, adverse event reporting and enrollment updates. The Clinical Research Coordinator 1 will communicate all problems, questions and/or clarifications to the Senior Coordinator Group Manager and/or Project Manager for their direct communication with the Sponsor.
The Clinical Research Coordinator 1 will work closely with the Recruitment Services Supervisor during the recruitment process. The Clinical Research Coordinator 1 will work with the Coordinating Staff, Investigator(s), and the Senior Coordinator Group Manager as often as necessary for successful completion of the trial.
The Clinical Research Coordinator 1 will document and maintain records of all oral communications with the Sponsor’s representative in the Study Master File. Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
Employment Type: Regular
Community / Marketing Title: 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.