Manages research study activities at off-site facilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
General Skill Requirements
- Must possess good communication and interpersonal relationship skills. Must be able to organize work with minimal supervision. Must be able to focus attention to minute details. Access, Work and Excel computer skills required.
In addition to the Essential Functions and Qualifications listed above, to perform the job successfully an individual must also possess the following General Skill Requirements.
Education and/or Other Requirements
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Accepts criticism and feedback; Changes approach or method to best fit the situation; ability to work with frustrating situations; work under pressure and on an irregular schedule such as unscheduled overtime, unanticipated changes in work pace; Works with numerous distractions.
- Attendance and Punctuality - Schedules time off in advance; Begins working on time; Keeps absences within guidelines; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Communications - Expresses ideas and thoughts verbally; Expresses ideas and thoughts in written form; Exhibits good listening and comprehension; Keeps others adequately informed; Selects and uses appropriate communication methods.
- Cooperation - Establishes and maintains effective relations; Exhibits tact and consideration; Displays positive outlook and pleasant manner; Offers assistance and support to co-workers; Works cooperatively in group situations; Works actively to resolve conflicts.
- Job Knowledge - Competent in required job skills and knowledge; Exhibits ability to learn and apply new skills; Keeps abreast of current developments; Requires minimal supervision; Displays understanding of how job relates to others; Uses resources effectively.
- Judgment - displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions; ability to work with and maintain confidential information.
- Problem solving - Identifies problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Resolves problems in early stages; Works well in group problem solving situations.
- Quality - Demonstrates accuracy and thoroughness; Displays commitment to excellence; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly; Achieves established goals.
- Concentration - Maintains attention to detail over extended period of time; continually aware of variations in changing situations.
- Supervision - ability to perform work independently or with minimal supervision; ability to assign and/or review work; train and/or evaluate other employees.
A bachelors degree in nursing or other health-related field is preferred. Pertinent LPN or RN licensure/registration must be maintained. Previous research experience and/or recent nursing experience is preferred. Responsibilities
- Coordinates screening and enrollment of clinical trial patients.
- Reviews physician patient schedules and assesses patients for possible clinical trial enrollment.
- Educates patients and families during the informed consent process.
- Registers patients and participants to protocols.
- Ensures eligibility requirements are met and reviews with physician investigator.
- Ensures protocol required patient testing is ordered and complete.
- Maintains record of recruitment strategies.
- Markets protocols as needed to meet recruitment goals.
- Coordinates clinical trial activities research done at the clinic and hospital
- Gathers and verifies source documents
- Verifies the accuracy, completeness and timely submission of case report forms.
- Collaborates with investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response.
- Interviews patient to assess adverse events, medication compliance, and patient reported outcomes.
- Obtains follow-up data required when patient is off active treatment.
- Corrects and resubmits data or answers queries within one week of receipt or as requested by pharmaceutical company; reviews expectation reports; notifies research base of errors.
- Maintains investigational drug (IND) inventory
- Reviews protocols and assesses current inventory of IND.
- Orders INDs from Pharmaceutical Management Branch at National Cancer Institute.
- Maintains inventory on individual drug accountability records.
- Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed.
- Assesses each IND for expiration dates and follows protocol and department guidelines for drug destruction.
- Gathers, completes, and tracks investigator required forms that comply with federal, Heartland NCORP and institutional guidelines. Ensures physician investigators complete required protocol training prior to patient enrollment.
- Coordinates credentialing of laboratory, radiology and radiation equipment as required by protocol.
- Use research database to track patient enrollments, patient demographics and status. Run reports to provide to information to physician investigators and DMH NCORP administrator.
- Disseminates protocol information.
- Reviews and educate physician investigators on new protocol activations, closures, and revisions.
- Serves as a professional resource regarding clinical trials, protocol procedures and protocol compliance for investigators, nurses, pharmacists, pathologists, radiologists and other health care personnel.
- Attends cancer conference to provide information about current protocol availability for presented cases.
- Attends cancer committee meetings to assist in the Commission on Cancer accreditation.
- Attends NCI research base meetings for updates on clinic trials.
- Demonstrates clinical competency by providing direct patient care as required by protocol. (EKGs, vitals, lab draws). Obtains protocol specific training as required to enroll patients on clinical trials.
- Order and track laboratory kits needed for research related blood draws. Process and ship specimens as required by protocol. Maintain hazardous materials education certification.
This job has expired.
- Performs other duties as assigned.