Clinical Research Coordinator

The Clinical Research Coordinator 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 outreports.
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 AND1 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

Application Question(s):

What are your compensation expectations?

Experience:

Clinical research: 1 year (Required)

License/Certification:

RN, LPN, or CMA (Preferred)

Ability to Commute:

Norfolk, VA 23502 (Required)

Work Location: In person

Eximia Clinical Research

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Clinical Research Coordinator