Job Summary

Provides expert research assistance and support to physicians, applicable departments, and health-related professionals on various clinical, health services, behavioral and organizational research studies/projects. Organizes, conducts and manages clinical and institutional research projects as assigned by the Clinical Operations Director of the CTC.

Responsibilities

• Markets the site • Assist with development of study budgets • Assists the PI in determining study feasibility • Knowledge of protocol requirements within specified setting • Maintains relationship with the study sponsor • Interacts with the IRB, office staff, and other department personnel • Educates patients and staff about the protocol • Prepares, submits, and maintains regulatory documents (e.g. IRB, FDA, etc.) • Tracks the study budget & payments • Documents study progress and communication • Documents participant study visits • Resolves queries on study data • Transcribes source information onto Case Report Forms (CRFs) • Coordinates, prepares for and participates in monitoring visits, audits & inspections • Orders study supplies as necessary • Closes out the study, and assures appropriate storage of study documentation Subject-Oriented Tasks • Recruits and enrolls study subjects • Develops and manages advertising for the study • Screens subjects for eligibility • Discusses the study with subjects and carries out the consent process • Schedules study visits and protocol research activities • Ensures that tests, procedures and research activities are conducted in compliance with the protocol • Interviews & evaluates subjects within the required time intervals provided in the protocol • Identifies, documents, reports and follows-up on adverse events • Maintains test article (drug or device) accountability • Oversees storage and administration of study medications • Provides documentation to Pharmacy for investigational drug dispensing • Coordinates study subject reimbursement • Process and organize new protocol as it arrives. • Process IRB packets for signatures and approvals as directed. • Maintain accurate filing for protocols for tracking original and subsequent activity on protocols and approval documentation. • Process addendums to active protocols. • Preparing documents for IRB. • Communicate the data gathered from research activities to Principal Investigator. • Document that IRB has been notified of a protocol change that is administrative or significant; confirm all IRB approvals. • Assist Clinical Trial Coordinator in performing telephone and written communications with physician providers and patients. • Excellent writing skills. • Collect and manage data needed per study. • Excellent Customer Service and Communication skills. • Initiative and ability to manage large and frequently changing workload. • Assist in performing telephone and written communications with physician providers and patients. • Assist in mentoring of Clinical Research Coordinator I as assigned. • Maintain education and knowledge as expected with experience in all Institutional and regulatory policies and processes and have ability to demonstrate execution. Maintain discussion with Clinical Operations Director and other more senior staff. • Other duties as assigned. • Provide education and training to Clinical Research Coordinator I. • Present education projects as assigned.

Knowledge, Skills & Abilities

Patient Group Knowledge (Only applies to positions with direct patient contact)The employee must possess/obtain (by the end of the orientation period) and demonstrate the knowledge and skills necessary to provide developmentally appropriate assessment, treatment or care as defined by the department’s identified patient ages. Specifically the employee must be able to demonstrate competency in: 1) ability to obtain and interpret information in terms of patient needs; 2) knowledge of growth and development; and 3) understanding of the range of treatment needed by the patients.Competency StatementMust demonstrate competency through an initial orientation and ongoing competency validation to independently perform tasks and additional duties as specified in the job description and the unit/department specific competency checklist.Common Duties and Responsibilities(Essential duties common to all positions)1. Maintain and document all applicable required education.2. Demonstrate positive customer service and co-worker relations.3. Comply with the company's attendance policy.4. Participate in the continuous, quality improvement activities of the department and institution.5. Perform work in a cost effective manner.6. Perform work in accordance with all departmental pay practices and scheduling policies, including but not limited to, overtime, various shift work, and on-call situations.7. Perform work in alignment with the overall mission and strategic plan of the organization.8. Follow organizational and departmental policies and procedures, as applicable.9. Perform related duties as assigned.

Education

Master's Degree (Required) Experience: 2 years.Substitution: Bachelor's degree with 4 years of experience or LPN with 7-9 years of experience may substitute for Master's degree and 2 years of experience.

Credentials

Cert Clinical Research Assoc (Required) Within 3 years of hireWithin 3 years of hire

Work Schedule: Days

Status: Per Diem

Location: Memorial-MSOB

Location of Job: US:WV:Charleston