The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out 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 Clinical 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.
- Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting and participating in the ICF process(es), 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.
- Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study.
- Develop, coordinate, and 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.
- Verify and escalate patient safety concerns by ensuring 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 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.
- Create and execute recruitment strategies defined by Clinical Research Team.
- Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
- Understand product development lifecycle and significance of protocol design including critical data points.
- Understand the disease process or condition under study.
- Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing one’s work on an ongoing basis and in preparation for monitor visits.
- Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope.
- Other duties as assigned.
Qualifications
Education/Experience:
- Bachelor’s degree and 2 years relevant experience in the life science industry OR
- Associate’s degree with 4 years relevant experience in the life science industry OR
- High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience.
Required Licenses/Certifications:
- Phlebotomy if applicable and required by state law.
- Intramuscular dose administration and preparation if applicable and required by state law.
- Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role.
Required Skills:
- Demonstrated knowledge of medical terminology.
- Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Proficient ability to work in a fast-paced environment.
- Proficient verbal, written, and organizational skills.
- Proficient interpersonal and communication skills.
- Proficient ability to work as a team player.
- Proficient ability to read, write, and speak English.
- Proficient ability to multi-task.
- Proficient ability to follow written guidelines.
- Proficient ability to work independently, plan and prioritize with minimal guidance.
- Proficient ability to be flexible/adapt as daily schedule may change rapidly.
- Must be detail oriented.
- Demonstrated problem solving and strategic decision making ability.
- Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
- Demonstrated leadership ability.
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 Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Jupiter, FL: Relocate before starting work (Required)
Work Location: In person
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