Clinical Research Coordinator -- Clinical Trials Center -- Memorial-Msob

Job Summary

Provide expert research assistance to CAMC physicians, faculty, 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 Project Director/Supervisor on a day-to-day basis.

Provide support and expert clinical trial expertise to the Director of the Clinical Trials Center, assigned Principal Investigator(s), faculty, 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 Trials Center Director on a day-to-day basis. This is to include project management and delegation of study activities.

Responsibilities

• Design of data collection methods, collecting, abstracting, and/or coding data for input to a computer for analysis. • Process and organize new protocols and assist in preparing IRB and IACUC grants documentation for institutional approval, including revisions, addendums, and renewals. • Verify and check data. • Perform library searches on MEDLINE as needed and peruse scientific journals for information. • Design data collection forms and survey questionnaire questions and forms. • Perform basic statistical analyses as assigned. • Report data and evaluations to Project Director. • Maintain and organize all required records, data, reports, and statistics per study. • Communicate findings/results to interested groups and Project Director. • Edit manuscripts and grant proposals as directed. • Utilize statistical software to perform statistical analyses and to produce graphic presentations of research data. • Excellent writing skills.

Research Study Management 50%

• Manage all studies assigned and exhibit project management and delegation skills to meet the expectations of the Clinical Trials Center. Meet job performance expectations for study metrics and team behavior/morale.

• Provide oversight and training as assigned to designated staff.

• Maintain clinical trial expertise through educational resources provided and through self-initiated education to provide training and education to peers.

• Assist with informed consent and subject/patient enrollment.

• Develops deep understanding of protocol requirements for each study.

• Collect and manage data per study protocol.

• Order study supplies as necessary.

• Ensure that tests, procedures, and research activities are conducted in compliance with the

• approved protocol.

• Maintain test article (drug or device) accountability.

• Oversee storage and administration of study medication.

• Process and organize new investigational product as it arrives.

• Provide documentation to pharmacy for investigational drug dispensing.

• Appropriately document participant study visits.

• Transcribe source information onto the Case Report Forms (CRFs.)

• Resolve queries on study data.

• Coordinate study subject reimbursement.

• Document and communicate study progress to sponsors and management.

• Assist Financial Analyst to track study budget and payments.

• Communicate with the IRB, staff and other personnel as required.

• Educate staff regarding study protocol.

• Screen subjects for study eligibility and recruits/enrolls study subjects.

• Discuss the study with subjects and carries out the consent process.

• Schedule study visits and protocol research activities.

• Interview & evaluate subjects within the required time intervals provided in the protocol.

• Communicate all IRB approved protocol changes to appropriate stakeholders.

• Share data and information gathered from research activities with the PI.

• Create and actively design and oversee recruitment and study execution to meet contractual goals. Investigate and provide feedback to Director and team in determining ongoing study feasibility and resolutions.

• Teamwork participation and communication skills to meet study and workload expected outcomes.

Administrative/Regulatory 45%

• Provide support to the research team, comprising the research director, investigator and/or study coordinator.

• Process and organize new protocols and assist in preparing IRB and grants documentation for

• institutional approval, including revisions, addendums, renewals, and signatures/approval as directed.

• Document that IRB has been notified of a protocol change that is administrative or significant,

• confirm all IRB approvals.

• Maintain accurate filing specific to each study and be able to track original and subsequent activity as well as approval documentation.

• Assist Financial Analyst with the continued accuracy of study budgets for trials to include feedback, timely and efficient reporting or financial and non-financial study activities, procedures, tests, and time to ensure that reimbursement is received timely to the Center and time is budgeted appropriately.

• Prepares documents for the Institutional Review Board (IRB)

• Processes IRB packets for signatures and approvals as directed.

• Prepare, submit, and maintain regulatory documents (e.g., IRB, Food and Drug Administration (FDA, etc.).

• Process addendums to active protocols.

• Document that the IRB has been notified of a protocol change as appropriate.

• Identify, document, report, and manage follow up for adverse events.

• Maintain accurate approval and tracking documentation.

• Coordinate, prepare, and participate in monitoring visits, regulatory body audits and inspections.

• Closes out the study, assure appropriate storage of study documentation and other subject oriented tasks.

Teamwork/Development 5%

• Serve as an ancillary research team member integral to trial success.

• Participate in departmental and study meetings as directed.

• Depict a professional image and competence in relation to our sponsors and investigators with a goal of increasing the likelihood of repeat business.

• Maintain and continue to complete professional development and knowledge from resources provided and self-education to depict competence in regulations, GCP, study protocols, research, and policies.

• Assist in onboarding and mentoring new employees as assigned to ensure consistency and competency in executing study protocols and activities correctly along with CAMC and department policies.

• Maintain education and knowledge in institutional and regulatory policies and processes.

• Participate in departmental or study meetings as directed.

Business Development 2%

• Market CAMC as a clinical trials site to sponsors.

• Maintain relationships with study sponsors.

• Develop and manage advertising for studies in collaboration with Marketing.

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

• Bachelor's Degree (Required) Education: Bachelor's degree in a related filed must be related to the type of research assigned to the position. Experience: 3 years progressive experience in health services and or outcomes research Comment: Must demonstrate competencies in developing a research study, assisting with conducting the study, performing statistical analysis, verbal and written communication (publications), or specialized decision support skills such as developing computer databases or computer assisted decision instruments.

Credentials

• No Certification, Competency or License 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