Clinical Research Coordinator

SUMMARY OF POSITION :


The Clinical Research Coordinator (Neurology) works under the direction of the Research Manager, Medical Director, and Principal Investigator to coordinate clinical studies as assigned. The CRC will be responsible for document preparation and submission to the IRB; direct interaction and managing care of patients with memory disorders; working with patient caregivers; obtaining and documenting informed consent as per FDA & ICH/GCP Guidelines; data entry and query resolution; assisting in training and credentialing of research staff; ensuring that SOPs, research protocols, and regulatory requirements are followed.


JOB RESPONSIBILITIES:

• Participate in the implementation and management of clinical trials including but not limited to pre-site visits, IRB submission, principal investigator communication, site initiation visits, patient screening, accrual and follow-up, informed consents, monitor visits, case report form submissions, and reporting of severe adverse events
• Assure adherence to SOPs, good clinical practice, and FDA regulations
• Work to ensure all IRB required submissions are submitted according to regulations
• Record accurate and timely data onto case report forms according to protocol/sponsor requirements
• Plan and implement pre-study activities on assigned trials by developing timelines for conducting and completing the clinical protocol
• Participate in patient screening, recruitment, enrollment and follow-up of assigned clinical trials
• Develop systems to aid in meeting accrual goals
• Resolve protocol queries as assigned
• Participate in scheduling and coordinating pre-study site visits, initiation visits, and monitoring visits
• Obtain informed consent, randomize patient according to protocol, schedule patient visits/tests and assess/document toxicities and adverse effects
• Perform Vital Signs, including measurement of study subject's weight, height, blood pressure, heart rate, temperature, oxygen saturation, and respirations according to study protocol
• Obtain blood and urine samples from study subjects and process according to study protocol and IATA specifications
• Retrieve specimens from pathology department and prepare for shipment according to study protocol and IATA specifications
• Prepare study subject and perform ECGs according to study protocol
• Administer and rate Cognitive Scales and Assessments as required by study protocol
• Assess patient compliance with study procedures and report any deviations to Lead Clinical Care Coordinator and sponsor
• Document protocol deviations and SAE's
• Dispense investigational product and maintain accountability logs
• Maintain source documentation files
• Work with monitors during visits to correct any data errors and answer queries
• Educate research staff and investigators on protocol specifics, investigational product, and other necessary items
• Support the activities of the principal investigators / sub-investigators
• Communicate effectively with physicians, patients, IRB, monitors, contract research organizations, and sponsors utilizing good interpersonal skills regarding the status of current and potential clinical trials
• Communicate with Clinical Research Manager on a regular basis concerning study accrual, screening numbers, monitoring visits, etc.
• Participate in the orientation and training of new staff involved in the implementation and management of clinical trials
• Participate in the development and management of quality assurance and performance improvement activities within the program

JOB SPECIFICATIONS:

Minimum Qualifications

• Bachelor's of Science degree from an accredited college or university (nursing degree accepted but not required)
• Experience with GCP and regulatory requirements
• Experience administering and rating Cognitive Scales/Assessments
• Perform venipuncture and ECGs
• Processing laboratory and pathology samples as required per study protocol

Preferred Experience & Skills

• 1+ years experience in Neurology clinical research
• 2+ years experience in data management and data management software
• ACRP (Association of Clinical Research Professionals), or SoCRA (Society of Clinical Research Associates)
• Ability to anticipate and timely escalate potential issues to leadership
• Ability to manage multiple tasks and prioritize accordingly
• Act as a team player with positive attitude and excellent interpersonal skills
• Proficient in using Microsoft Excel, Word, and PowerPoint
• Ability to gather, organize, and verify data for projects
• Ability to maintain attention to detail to avoid errors of a technical or judgmental nature
• Maintain confidentiality of data and patient information according to HIPPA regulations