Clinical Development Specialist

Location
St Louis, MO
Posted
Jun 09, 2022
Required Education
Bachelors Degree
Position Type
Full time
General Summary
The Clinical Development Specialist is responsible for developing positive relationships with personnel at clinical study sites by providing product training and expertise, clinical protocol training, continuing education, and study support. The goals of this position are to drive patient recruitment and enrollment, protocol compliance and enhance procedure outcomes. Additional responsibilities include conducting protocol, therapeutic area, and device training/presentations for internal and external stakeholders. We are currently interviewing candidates in the following cities: St Louis, Denver, Phoenix, San Francisco, and Minneapolis.

Specific Duties and Responsibilities
• Define strategies to drive recruitment and enrollment at clinical sites to support Clinical Affairs enrollment goals.
• Establish regular touch points with site investigators and research teams to elevate study visibility, reinforce study enrollment, streamline patient screening activities, support site teams with tools and best practices to qualify study subjects, identify and address barriers to enrollment and coordinate with cross-functional team to ensure clinical site productivity.*
• Develop relationships with key stakeholders.*
• Gather data on patient pathway, track enrollment progress and identify trends at site, research staff, and other clinical trial stakeholder needs.*
• Facilitate clinical study awareness activities to support site investigators including organizing potential referral meetings to generate education and awareness for the study.*
• Engage with site investigators, research teams, and hospital personnel to raise awareness with neighboring hospitals through events, newsletters, social media, etc..*
• Coordinate communication to prioritize enrollment activities at the site and to ensure excellent procedural outcomes.*
• Collect and analyze statistical data to evaluate the subject populations enrolled in Penumbra clinical studies as it relates to diversity, equity, and inclusion (DE&I).*
• Research, develop and recommend creative enrollment strategies to foster broader DE&I in Penumbra clinical studies.*
• Maintain up to date product and clinical trial knowledge and actively participate in internal and external education programs.*
• Provide training as needed at investigational sites on product use and clinical protocols.*
• Prepare and conduct site qualification and initiation presentations.*
• Act as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively.*
• Perform device inventory reconciliation.*
• Report field complaints and help support any corrective action items, if needed.*
• Collaborate with internal/cross functional team members.*
• Provide training to internal teams on protocol, therapeutic area, and training at onset of study and throughout lifecycle of study.*
• Provide training and mentorship to new Clinical Affairs team members, as needed.*
• Provide procedural case support for designated clinical trials.* 

Required Qualifications:
Minimum education and experience:
• Bachelor’s degree and 5+ years’ experience in clinical/scientific research, nursing, medical devices, or pharmaceutical industry, or an equivalent combination of education and experience.
• Willingness and ability to travel overnight 50-60% of the time.

Preferred Qualifications:
• Undergrad degree in biological sciences or another health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) is highly preferred.
• 2+ years of clinical monitoring experience preferred. 
• Excellent oral presentation skills and the ability to influence including the ability to develop, lead and facilitate educational programs and presentations to internal and external shareholders.
• Outstanding written and interpersonal communication skills; attention to detail; demonstrated problem solver and the ability to work on multiple projects simultaneously, in addition to being computer literate (including PowerPoint and excel), and familiarity with the FDA regulations governing the conduct of clinical trials.
• Familiarity with Cath lab, IR lab, OR procedures and policies, and the ability to leverage and/or engage others to accomplish projects.