Study Coordinator ll

Johnson County Clintrials•Houston, TX

22d•$18 - $25•Onsite

About The Position

Study Coordinator II Location: Juno Research in Houston, TX Department: Study Management Purpose: The Study Coordinator position is responsible for the coordination and administration of clinical studies under the direction of the Site Director, and the Principal Investigator. Position Summary: The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director. Key Responsibilities (Essential Functions): Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials Assist with mentoring and training study team members Maintain required records of study activity including study logs, case report forms, and/or regulatory forms Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements. Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc. Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information. Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits. Professional communication and collaborative work ethics with CRAs at Site visits. Order and track supplies or devices necessary for study completion. Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes. Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies. Track enrollment status of volunteers and documentation in Clinical Conductor system. Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc. Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups Collect, process and ship laboratory specimens Adherent to safety and privacy regulations Key Responsibilities may vary depending on work location

Requirements

Excellent communication, interpersonal, analytical and problem-solving skills
Microsoft Office Suite proficiency
Writing and verbal communication skills
Knowledge of medical terminology and concepts
Proficient typing and data entry skills
Strong study documentation skills in compliance with ALCOA+ preferred
Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadlines
Must be fluent in speaking and understanding Spanish and English
Foreign Medical Graduate or Medical Assistant with extensive medical knowledge and training
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
BS/BA in Life Science or related discipline or equivalent work experience
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Minimum 3 years of experience coordinating clinical trials, including the activities listed above
Demonstrated relationship building, with strong verbal and written skills.
Ability to successfully coordinate protocols with overlapping timelines
Ability to explain importance of GCP guidelines and their application
Ability to train others on coordinating responsibilities and protocol adherence
Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
Strong interpersonal skills with attention to detail a must
Proven ethical and professional codes of conduct
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.

Nice To Haves

Previous nursing, medical assistant experience in a clinical setting a plus
CCRC certification a plus

Responsibilities

Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
Manage multiple concurrent trials
Assist with mentoring and training study team members
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
Professional communication and collaborative work ethics with CRAs at Site visits.
Order and track supplies or devices necessary for study completion.
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
Track enrollment status of volunteers and documentation in Clinical Conductor system.
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Collect, process and ship laboratory specimens
Adherent to safety and privacy regulations