We are looking for a unique individual with clinical practice expertise (ARNP, PA) with a strong interest in coordinating and managing clinical trials with the Seattle Malaria Clinical Trials Center. The Clinical Trials Manager (CTM) role is primarily focused on ensuring the efficient and effective implementation of malaria vaccine research studies involving human subjects, from protocol development through long-term follow-up. This includes effective project management, communicating effectively with diverse stakeholders, production of training and study specific procedure materials, developing and driving timelines and adjusting expectations as necessary.
The Clinical Research Practitioner role will be as a sub-investigator for clinical research studies involving human subjects for the Seattle MCTC. The Clinical Research Practitioner provides medical history review, medical care, adverse event and laboratory evaluation of human subjects participating in clinical trials. The position requires the performance of responsibilities with a high level of independence within the scope of study protocol(s) and guidelines. Position is based in Seattle, Washington and requires travel to local study sites for on-site training or assessment.
SCOPE OF RESPONSIBILITIES
The incumbent reports to the Medical Director of the Seattle MCTC. Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, and in carrying-out complex multi-site research management responsibilities. Problems and challenges that arise in the implementation of projects/studies are handled by the CTM, soliciting assistance from other stakeholders and informing the Executive Director as appropriate.
CLINICAL TRIAL MANAGER
Perform some or all of the following responsibilities:
1. Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units, the sponsor, and others as needed.
2. Manage sites related to study implementation, including the start-up timeline, enrollment, and site performance.
3. In collaboration with the protocol team, develop, review, and/or revise research materials including study information sheet, trial monitoring guidelines and instructions, study aids (phone screening script, participant comprehension test, etc.), data collection instruments, educational materials, and recruitment materials.
4. Develop content of data collection instruments (i.e. Case Report Forms), as negotiated with the data center and protocol team, on a protocol-by-protocol basis.
5. Prepare source documents and protocol-specific training study materials for study site use.
6. Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grant/contract, data management center, laboratory program and Fred Hutchinson Cancer Research Center specifications.
7. Prepare site monitoring plan in collaboration with sponsor and clinical research site.
8. Maintain appropriate source documentation, and develop case report forms.
9. Assist with compilation and presentation of status reports to PI, clinical research team, and sponsor.
10. For assigned studies, enter data accurately from source documents into electronic case report forms.
11. Coordinate monitoring visits; respond to queries and other requests from study monitors.
12. Prepare laboratory kits and deliver to appropriate locations on campus. Assist in transport and shipment of laboratory specimens. May also be required to oversee drug self-administration by patients, conduct non-clinical ECGs, and administer study questionnaires.
13. Develop and distribute recruitment and advertising materials. Provide support for community education and recruitment for the study.
14. Help to maintain the compliance of volunteers to their study regimen
15. Set project goals and drive implementation timelines to ensure that all implementation activities are completed on time. Ensure collaboration and communication, including identification of milestones, issues & resolutions.
16. Coordinate development of new sites. Assess capacity of study sites to conduct research protocols in accordance with SOPs, regulatory requirements, and principles of Good Clinical Practice.
17. Coordinate site space and equipment planning and utilization, evaluate current project/study needs, anticipate future needs, and oversee acquisition of space/equipment.
18. Represent and advocate for sites in strategic & operational discussions. Serve as the primary "go-to person" for site knowledge and site-related queries.
19. Drawing on knowledge and relationships with sites' operations, provide input to protocol teams on site expertise and potential obstacles and challenges. Develop site-specific timelines and provide updates on protocol implementation such as enrollment, vaccination, and retention.
20. Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and sponsor.
21. Plan and attend committee meetings, monitor activities to ensure objectives have been met within designated time frame, and coordinate follow-up activities.
22. Other duties as assigned.
CLINICAL RESEARCH PRACTITIONER
In addition to the CTM duties, the CRNP will:
1. Determine patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment in research studies in accordance with regulatory and GCP guidelines and institutional policy including:
- Provide a complete explanation of a study to potential volunteers so as to obtain informed consent.
- Record and evaluate medical, social and sexual histories.
- Draw blood for screening labs and interpret the results for inclusion/exclusion criteria for our studies as well as for medical follow-up if needed.
- Provide HIV pre and posttest counseling.
- Provide pregnancy prevention counseling for women, including contraceptive counseling as needed
- Perform complete physical exams on male and female volunteers.
- Follow the complete study protocol for each participant visit.
2. Help to maintain the compliance of volunteers to their study regimen.
3. Maintain appropriate source documentation, and complete case report forms. Assist with compilation and presentation of status reports to Principal Investigator (PI), clinical research team, and sponsors.
4. Provide various forms of health education to study volunteers and provide appropriate referrals to community medical, social, substance abuse and mental health programs if needed.
5. Provide support for community education and recruitment.
6. Collect and assemble data for various research studies.
7. Perform clinical procedures including vital signs, vaccine administration, blood draws and complete physical exams.
8. Assist with the daily operations of a research study.
9. Act as a clinical liaison for designated protocols with clinical teams, participants, other institutions, and pharmaceutical companies. Educate clinical teams, ancillary departments, participants, and families about protocols to ensure safe and accurate implementation in compliance with protocol requirements.
10. Assist in developing tools for study implementation including data collection tools and study reference materials. Assist in developing orders for protocols to reflect the actions needed to implement all stages of the protocol.
11. Identify, assess, and report adverse events in accordance with protocol and regulatory guidelines and institutional policy.
12. For designated protocols, assist the PI and/or protocol team with protocol development, revision, and study analysis.
13. Provide leadership and guidance to program/research assistants in the execution of their duties relative to protocol implementation.
14. Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
- BA/BS in related field required; Licensed ARNP or PA in the state of Washington.
- This position requires excellent organizational skills, strong problem-solving capabilities, and the ability to prioritize multiple competing tasks in a dynamic environment.
- Strong written and verbal communication skills including computer skills are necessary.
- Previous experience in clinical trial research and clinical data collection is preferred.
Key Skills and Abilities:
- Must be able to take direction from Medical Director as well as work independently.
- The willingness to work as part of a cohesive team is essential.
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