Clinical Research Coordinator

Provision Healthcare•Knoxville, TN

18d

About The Position

The Clinical Research Coordinator (Utility) works under the direction of the Research Lead, 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; oncology patients; Pulmonology patients, and any new areas the we may open. 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.

Requirements

Graduate of an accredited college or university with a bachelor’s degree of science.
(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

Nice To Haves

1+ years experience in 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

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