Serving as a value-added resource and extension of the Companyu2019s Clinical Operations Department, the clinical trial outreach specialist will work as a Community Outreach Specialist (COS) to assist the study site in developing relationships with potential referring facilities for the Company's Phase 2 protocol. In addition to outreach to specific Long Term Care (LTC) facilities, the COS may also work with the site to review their internal databases for potential patients and participate in local community activities to represent the study site and communicate directly to potential patients and caregivers regarding the study.
This position will include compliance, regulatory and study specific training. Documentation of all interactions and progress, metrics, and CRO data-base reporting will be directed and executed in accordance with policy. The Clinical Project Manager (CPM) or designee will be responsible for communicating the location and contact information of the sites requesting resources as well as any specific information regarding the siteu2019s resourcing request to the Community Outreach Specialist.
- Participate in and successfully complete all compliance training and regulatory education relevant to performing the project.
- Complete internal education/training on relevant SOPs and study protocol.
- Comply with all applicable laws, regulations, policies, procedures and training relevant to performing the project.
- Identify and conduct outreach to local LTC and other healthcare facilities in order to develop relationships, engage and educate regarding the study and generate referrals to the study site.
- Prepare for and present study information as needed in formal presentations to facility staff.
- Document all interactions and submit executed documents promptly.
- Communicate investigator/study coordinator inquiries requiring follow up to the designated contacts within that department and to the CPM or designee.
- Communicate any Adverse Event information, reports of concern or product complaints in accordance with the terms of the Consultant Services Agreement.
- Participate in regular progress meetings via teleconference as scheduled
- Schedule travel and submit associated expenses in accordance with travel policies.
- BSN preferred, BS/BA Degree Required.
- 3+ years of clinical research experience in an academic, healthcare, or industry setting is required. This may include, but is not limited to: research director, research nurse, clinical professor, clinical research coordinator, research manager, liaison in the area of research.
- Significant knowledge of study site logistics and a good understanding of recruitment techniques and community outreach is expected.
- Experience with CNS studies, ideally Alzheimeru2019s disease and/or sleep is preferred
- Familiarity with Long Term Care (LTC) facilities is preferred.
- Exceptional interpersonal skills including excellent verbal and written communication.
- Understanding of the clinical trial process and ability to earn the trust of and work collaboratively with the trial site investigators and staff to aid in recruitment and retention of patients as well as the ability to engage in discussions regarding the protocol, patient qualifications and required protocol assessments.
- Strong organizational and time management skills are required
- Computer skills including SharePoint, excel, word, power point and programs such as "WebEx" are expected.
- A willingness and ability to travel frequently is required