Clinical Scientist I: Neurology
Participate in all aspects of clinical development and study management under the direction of the Director, which includes providing logistical and/or scientific support to planned and ongoing trials.
Capable of performing all of the activities and responsibilities with direction of the Director, Associate Director, or designee as follows:
-Delivers Business Results
· Support the successful and timely execution of clinical trials by monitoring and tracking clinical trial progress through regular phone contact with each site; utilizing standard and ad-hoc tracking tools to capture pertinent information and then summarizing site and project status weekly
· Identify and assist in selection of qualified investigators and study sites in collaboration with Global Monitoring Operations
· Monitor data on an ongoing basis during the course of the study; identify potential issues with data and provides feedback and resolutions to remediate issues
· Assist in the preparation of study documents (e.g. synopsis, protocol), remediate and report study issues (e.g. audit reports), report study results (e.g. Clinical Study Report)
· Report issues to senior staff with an organized approach providing viable options for resolution based on prior experience and current study trends
· Assist in the efficient tracking and management of study budgets and provide timely resolution to financial inquiries
-Enhances Organizational Performance
· Assist in developing the Monitoring Plan with the assigned Lead Regional Site Manager
· Serve as in-house contact for sites, Regional Site Managers and vendors, responding to issues, recommending corrective actions, following up on outcomes and documenting results
· Manage interactions with external stakeholders including investigators, CROs, and vendors
· Participate in interactions with Contract Research Organizations, as required
· Contribute to process improvement efforts including task forces and committees.
-Demonstrates Personal Leadership
· Participate in and contribute to clinical team and Regional Site Manager meetings, and identify and coordinate the timely execution of inter and intra-departmental milestones
· Co-monitors with Field Site Managers on visits to sites to become familiar with and potentially help resolve issues
· Assist senior team members in the planning of investigator meetings and participates by developing and delivering study specific training presentations
-Develops Human Capital
· Advise junior staff members to improve quality of outcomes and to maintain team morale
· Maintain professional relationships with team members, company staff and study site staff
Qualified candidates will have a bachelor’s degree in life sciences
(preferred) and at least 3-5 years experience in clinical research. Preference will be given to candidates with clinical trial management and some protocol development experience. Medical and/or scientific knowledge in assigned therapeutic area advantageous. Prior field monitoring experience desirable.
Strong written and verbal communication skills are required as well as proven ability to interact with different functional groups.
Other key qualifications include knowledge of GCP/ICH guidelines and FDA regulations, experience with clinical trial design and basic knowledge of statistics, good organizational, interpersonal and presentation skills, proficiency in computer and software skills (Word, Outlook, Excel, PowerPoint).