Clinical Research Coordinator (Neuro-Psychiatric) Job at Eximia Research, Raleigh, NC

SG5VWWxWNk15bDBYMEZDaHFra3lONDlFVmc9PQ==
  • Eximia Research
  • Raleigh, NC

Job Description

Company Description

Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.

Clinical Research Coordinator

Eximia Clinical Research is looking for a CRC to join our team. As the CRC, you will act as a member of the clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Eximia Clinical Research’s SOPs.

**Specifically we would like someone with experience in Neuro-Psychiatric trials

Role & Responsibilities:

  • Serve as member of a study team to execute clinical trials
  • Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Clinical Research’s SOPs
  • 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 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.
  • 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.
  • Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
  • Ensure confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Research confidential information is maintained by all team members
  • Develop communication and escalation strategies within teams to that 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 Research 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
  • Ensure the creation, collection and submission of 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 in conjunction with patient recruitment staff
  • Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
  • Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
  • Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
  • Develop Quality Control strategies for team member projects
  • 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.
  • Understand the disease process or condition under study
  • Other duties as assigned

Qualifications

Education/Experience:

  • Bachelor’s degree and 2 years as a Clinical Research Coordinator

Required Licenses/Certifications:

  • Phlebotomy if applicable and required by state law
  • Intravenous/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:

  • Advanced 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
  • Advanced verbal, written, and organizational skills
  • Advanced interpersonal and communication skills
  • Advanced ability to work as a team player
  • Advanced ability to read, write, and speak English
  • Demonstrated ability to multi-task
  • Advanced ability to follow written guidelines
  • Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives
  • Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
  • Must be detail oriented
  • Proficient problem solving and strategic decision making ability.
  • Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
  • Proficient leader, mentor and team builder

Job Tags

Flexible hours,

Similar Jobs

Find Great People | FGP

Fleet Coordinator Job at Find Great People | FGP

 .... Ensure all fleet operations comply with federal, state, and local regulations, including DOT, OSHA, and company-specific policies....  ...Familiarity with fleet safety and maintenance certifications (e.g., ASE, CDL) is a plus. ~ Ability to interpret and apply complex regulatory... 

Cherry Bekaert

SEO Specialist Job at Cherry Bekaert

 ...focused on enabling your career growth and continuous professional development. Our Marketing Department team is looking for a SEO Specialist. The SEO Specialist will have the opportunity to work remotely from within the United States.Are you passionate about driving... 

Mumford Bjorkman Associates

Coating Inspector Job at Mumford Bjorkman Associates

&##127775; Join Our Dynamic Team of Coating Inspectors! &##127775; Are you seeking a fulfilling long-term career opportunity? Our small and specialized Tank Inspection firm, located in Newark, DE, serving the Mid-Atlantic region of the United States, is expanding its team...

National Logistics Service (NLSfreight)

Entry-Level Logistics Account Executive Job at National Logistics Service (NLSfreight)

 ...task ~ Self-starter who can work well under pressure and is motivated to succeed ~ Must be willing to learn Benefits Health care reimbursement Company 401K match Gym membership Paid Vacation Paid time off Paid training Exciting work culture... 

Signify Technology

Machine Learning Systems Engineer Job at Signify Technology

Machine Learning Systems Engineer 3D Generative AI A well-funded and fast-growing company at the forefront of 3D generative AI is seeking a Machine Learning Systems Engineer to help build the most advanced end-to-end machine learning infrastructure for 3D content...