Job Summary

Coordinates all aspects of clinical research trials. Assists in managing relationships with sponsors, physicians, applicable departments, and other staff for organizational research studies/projects. Manages research projects as assigned by the Operations Director of the Clinical Trials Center (CTC).

Responsibilities

Research Study Management 45% • Develops deep understanding of protocol requirements for each study • Collects and manages data per study protocol • Orders study supplies as necessary • Processes and organizes new investigational product as it arrives • Provides documentation to pharmacy for investigational drug dispensing • Appropriately documents participant study visits • Transcribes source information onto the Case Report Forms (CRFs) • Resolves queries on study data • Coordinates study subject reimbursement • Documents and communicates study progress to sponsors and management • Tracks study budget and payments Administrative/Regulatory 30% • Assists Principal Investigator in determining study feasibility • Assists with development of study budgets • Prepares documents for the Institutional Review Board (IRB) • Processes IRB packets for signatures and approvals as directed • Ensures that tests, procedures and research activities are conducted in compliance with the approved protocol • Maintains test article (drug or device) accountability • Oversees storage and administration of study medication • Prepares, submits and maintains regulatory documents (e.g. IRB, Food and Drug Administration (FDA), etc.) • Processes addendums to active protocols • Documents that the IRB has been notified of a protocol change as appropriate • Identifies, documents, reports and manages follow up for adverse events • Maintains accurate approval and tracking documentation • Coordinates, prepares for and participates in monitoring visits, regulatory body audits and inspections • Closes out the study, assures appropriate storage of study documentation and other subject- oriented tasks Physician and Patient Communication 20% • Communicates with sponsor and PI regarding trial startup, progress and closure • Communicates with the IRB, staff and other personnel as required • Educates staff regarding study protocol • Screens subjects for study eligibility and recruits/enrolls study subjects • Discusses the study with subjects and carries out the consent process • Schedules study visits and protocol research activities • Interviews & evaluates subjects within the required time intervals provided in the protocol • Communicates all IRB approved protocol changes to appropriate stakeholders • Shares data and information gathered from research activities with the PI Teamwork/Development 3% • Assist in onboarding and mentoring new employees as assigned • Maintain education and knowledge in institutional and regulatory policies and processes • Participate in departmental or study meetings as directed Business Development 2% • Markets CAMC as a clinical trials site to sponsors • Maintains relationships with study sponsors • Develops and manages advertising for studies in collaboration with Marketing and Communications as appropriate

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 Statement Must 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: 2-3 years of experience or LPN with 3-5 years of experience

Substitution: May substitute Master's degree and less than 2 years of experience for Bachelor's degree and more experience.

Credentials

• Drivers License (Required) CCRP-Certified Clinical Research Professional desired, not requiredCCRP-Certified Clinical Research Professional desired, not required

Work Schedule: Days

Status: Full Time Regular 1.0

Location: Memorial-MSOB

Location of Job: US:WV:Charleston

Talent Acquisition Specialist: Tamara B. Young tammy.young@vandaliahealth.org