Job Summary

Works with the research leaders in clinical departments and service lines to manage the strategic portfolio of research projects within that specialty area in order to fulfill our mission and benefit our patients, our community and CAMC. Coordinates selected clinical research trials and manages projects assigned by the Operations Director of the Clinical Trials Center or other research leaders.

Responsibilities

Administrative/Regulatory 30% • Prepares feasibility analysis independently or with collaboration with Principal Investigator (PI) and management • Develops 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 • Conducts quality assurance audits for the department or service line research portfolio Research Study Management 20% • 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 • Manages study budgets to help departmental productivity and demonstrate profitability where appropriate Communication 20% • Liaises with sponsor and PI regarding trial startup, expected timelines, progress and study 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 15% • Collaborates across the Institute of Academic Medicine to support research portfolio management • Supports and co-leads department or service line research meetings • Onboards, trains and mentors new employees as assigned • Prepares and presents formal educational sessions/workshops to physicians, staff and other stakeholders as directed • Maintain expertise in institutional and regulatory policies and processes • Participates in or leads departmental or service line meetings as directed Business Development 15% • Works with leadership and physician stakeholders to review service line or department research portfolio and identify therapeutic gaps • Identifies new trials to close therapeutic gaps • Markets CAMC as a clinical trials site to sponsors • Develops, maintains and manages 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: Master's Degree - Related Field and 3 - 5 years experience Substitution: Bachelor's degree or LPN with 5 - 7 years of experience

Credentials

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

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