Job Description
The Clinical Research Coordinator conducts and manages clinical trials in accordance with the study protocol, GCP, and Eximia Research Network’s SOPs.
Role & Responsibilities:
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Research Network’s SOPs
- Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
- Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
- 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, participates in the ICF process(es), after 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 in accordance with ALCOA-C principles 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 Eximia Clinical Network 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 Eximia Clinical Network SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner as set forth in the Clinical Trial Agreement
- 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
Education/Experience:
- Bachelor’s degree with 1 year of relevant experience in the life science industry OR
- Associate’s degree with 2 years of relevant experience in the life science industry OR
- High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry
Required Licenses/Certifications:
- Phlebotomy if applicable and required by state law
- Intramuscular dose administration and preparation if applicable and required by state law
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 to moderate walking required
- Limited to lifting up to 30 pounds
Job Tags
Work at office, Local area, Flexible hours,