SITE FEASIBILITY SPECIALIST II
Location: Carlsbad, California
Job Type: Full time
The Site Feasibility Specialist II is a highly driven professional who will identify, contact, visit, build, and maintain strong relationships with high performing sites, investigators, and networks for the conduct of feasibility and potential study participation.
- Identify, contact, and build relationships with study investigators/sites and networks in assigned areas (e.g., region, countries, or therapeutic area) for the conduct of feasibility and potential study participation
- Build investigator database and feasibility management system (e.g., investigator profiles, country demographics)
- Creates/Coordinate the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (feasibility manger, PM, etc.), & finalizes draft for Sponsor review, as required. Works with PM to
- Create and disseminate Confidential Disclosure Agreements (CDAs)/Questionnaires to sites and follow up accordingly to ascertain interest and to meet study timelines.
- Adheres to study timelines, documents, and communicates updates to Project Managers.
- Liaise with the project manager to understand studies’ budgets and negotiates and finalizes budgets with the investigational sites.
- Responsible for transitioning sites from Site Feasibility to SSU (Study Start Up) representative.
- Conduct site qualification visits (on-site and remotely)
- Participate in project team meetings.
- Leads in training and development of junior staff.
- May be assigned additional Clinical Operations and Business Development tasks
- Help create a fun, rewarding and collaborative environment.
KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process related to feasibility, study start-up and regulatory requirements.
- Ability to interact effectively with investigators and cross-functional teams; in-vitro diagnostics experience is preferred.
- Excellent organizational, time management and interpersonal skills with track record for attention to detail.
- Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Strong written and verbal communication skills to express ideas to study personnel, internal and sponsor team members.
- Ability to travel (up to 25%-50%) to clinical sites.
- Ability to handle difficult situations professionally and maintain a professional and caring demeanor.
- Must be able to work independently and within a team environment.
- Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Must be responsible, creative, and highly motivated.
What your background should look like:
- Bachelor’s degree (or equivalent) in science-related field preferred
- 2-3 years relevant experience in clinical research, monitoring or study start up
- Equivalent combination of education, training, and experience