Senior Clinical Research Coordinator - CNS

Company
AES
Location
Queens, United States
Salary
Competitive
Posted
19 Jul 2019
Closes
02 Aug 2019
Ref
1synexus/TP/13884/2345
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Summary

We are seeking aSenior Clinical Research Coordinator to join our CNS site in Queens, NY!

The Clinical Research Coordinator - CNS (CRC-CNS), as delegated by the principal investigator, primarily executes and coordinates daily Psychiatric, Central Nervous System (CNS) and general medicine clinical research activities according to the organizations SOPs, GCP and FDA/ICH guidelines. May assist the /Site Director with quality control and leadership activities and may provide leadership/guidance, support mentoring and training in the absence of the Site Director. Schedules and conducts study specific training and site in-services to study related staff on new or amended protocols; educates patients and their families about treatments and possible side effects. The CRC-CNS has demonstrated clinical expertise in CNS related research by conducting psychiatric rating scales/assessments and by working with people with varying degrees ofmentalillnesses in an out-patient and in-patient environment. Optimizes recruitment and enrollment while maintaining a high level of quality. Additionally, this role seeks to improve the sites operations by providing support in management of change, development within the site and process improvement. The CRC-CNS typically carries a larger study load and is able to function at a high level of competency with more complex or high enrolling trials. The CRC-CNS must also be able to perform clinical tasks (i.e. phlebotomy, EKGs, vital signs, etc.).

Role Responsibility

  • Utilizes universal precautions, obtains and maintains certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them;
  • Work under direction of principal investigator. Must be a leader at the site and available to assist staff and management in the activities of a research site;
  • Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
  • Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;
  • Perform interview/ratings on study subjects to determine current levels of functioning and to create a clinical impression of the study subject's current mood throughout the duration of the study;
  • Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;
  • Serve as Study Coordinator for multiple CNS and general medical clinical trials;
  • Manage onsite research protocol activities and assist staff in organization to ensure study protocol procedures and good clinical practices:
  • Manage and participate in study recruitment to ensure enrollment goals are met or exceeded;
  • Direct and guide Research Assistant and other Coordinators on study specific tasks;
  • Provide leadership to junior staff at the site (non-management responsibilities);
  • May perform managerial duties as assigned (time card and PTO approval) by senior management in the absence of on-site management. May take on other responsibilities at the site in the absence of the Site Manager/Director
  • Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up, schedules patients, obtains informed consent, administers study medications;
  • Perform appropriate research protocol procedures which may include, but are not limited to: vital signs, pregnancy tests, blood collection and processing, ECGs, alcohol breath tests and administers pain assessments;
  • Ensure study related reports and patient results are reviewed by investigator in timely manner;
  • Responsible for completion of case report forms, ensuring accuracy of data and reporting of adverse events to sponsor;
  • Dispense investigational product and instruct subjects on usage and potential drug interactions;
  • Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.;
  • Prepare presentations to schedule training for physicians, nurses and staff on research protocol;
  • Provide patient education regarding disease process and involves patient and family in decision-making processes;
  • Generate patient enrollment and tracking reports for supervisor. Tabulate enrollment statistics;
  • Maintain accountability of own ongoing professional growth and development;
  • Perform necessary functions as approved by Operations, for the conduct of clinical research;
  • Maintain strict confidentiality of patients, employees and sensitive company information at all times and adheres to HIPAA Guidelines;
  • Responsible for drug accountability, maintaining study product logs and inventory of supplies;
  • Coordinate and conduct pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative, including completion of minutes and follow-up reports;
  • Maintain contact and interacts with monitors and sponsors;
  • Attend investigator meetings; and
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.


Ideal Candidate

  • A Bachelor's degree AND a minimum of 3years of experience conducting CNS research trials. More than 5years' experience in study coordination, in addition to a combination of education and CNS related experience, may be substituted for education listed.
  • Certification as a Clinical Research Coordinator is preferred.
  • Prior CNS clinical and research experience providing care to people with varying degrees ofmentalillnesses; in-patient research experience required.
  • Expertise with GCP and FDA/ICH regulations; Must adhere to protocol requirements;
  • Phlebotomy and EKG experience;
  • Exceptional organizational skills, attention to detail and follow through;
  • Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;
  • Ability to type proficiently (35+ wpm);
  • Excellent verbal and written communication skills;
  • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
  • Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;
  • Must be a strong leader, willing to lead by example and willingness to step in and do any job within their site;
  • Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information;
  • Must be a strong leader and willing to train others.


Package Description

We offera comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!

We are an Affirmative Action and Equal Opportunity Employer.

About Synexus

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.

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