Job Description
Looking for a Medical Assistant to join our team as a Clinical Research Coordinator in Spokane, WA.
**Relocation candidates will not be considered at this time.
Summary:
The Clinical Research Coordinator conducts and manages clinical trials in accordance with the study protocol,GCP, and company's SOPs.
Duties/Responsibilities:
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and company's SOPs
- Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
- Implement research and administrative strategies to successfully manage assigned protocols.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
- Maintain confidentiality of patient protected health information, sponsor confidential information and company confidential information
- Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and company's SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
- Ensure staff are delegated and trained appropriately and documented
- Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
- Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
- Execute recruitment strategies defined by Clinical Research Team
- Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
- Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
- Promote respect for cultural diversity and conventions with all individuals.
Qualifications
Required Skills:
- Demonstrated knowledge of medical terminology
- Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Demonstrated ability to work in a fast-paced environment
- Demonstrated verbal, written, and organizational skills
- Demonstrated interpersonal and communication skills
- Demonstrated ability to work as a team player
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to multi-task
- Demonstrated ability to follow written guidelines
- Demonstrated ability to work independently, plan and prioritize with some guidance
- Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
- Must be detail oriented
- Demonstrated problem solving and strategic decision making ability.
- Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.
Required Physical Abilities:
- Sit or stand for long periods of time
- Travel locally and nationally
- Communicate in person and by a telephone
- Limited walking required
- Limited to lifting up to 30 pounds
Job Tags
Relocation, Flexible hours,