Performs study start up responsibilities by:
- Performing new award tasks such as entering new studies into the MedComm database, creating Medical Affairs and Medical Communications study-specific folders, organizing study documents, requesting signed Protocols, entering document costs in the new award spreadsheet, and notifiying assigned Project Teams
- Performing a concise and thorough review of study Protocols related to imaging requirements, schedules and windows.
- Creating, modifying and finalizing Site Manuals, associated fillable forms, and labels
- Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Protocol Amendment Impact Forms (PAIFs), Notes to File (NTFs), Corrections, non-Quality Event Deviation Reports, and Transfers of Obligation (ToO) as required/applicable.
- Creating, modifying and finalizing paper Source Documents/eCRFs for reads performed outside a standard application (e.g., based on ToOs) on an as-needed basis.
- Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
- Attending internal and external meetings relating to the Site Manuals, CRs and any other MedComm-related study start-up documents
- Creating, updating and modifying the MedComm web pages for ease of access by IO, CPM, MA and any other departments who use the web pages. This includes running the Scheduled Tasks for generating the webpages
- Performing Project Close-outs as they occur based on receipt of Project Closeout Requests
- Reviewing, modifying and developing Standard Operating Procedures (SOPs)/Work Instructions pertinent to Medical Communications (and Medical Affairs, as applicable).
- Updating MW training modules, as required.
- Assist in the review and updating of the Reader Training Package (i.e., Charter Training Slides [CTS] and CTS quiz[zes]), when requested.
- Manages the clinical study document development process by:
- Creating, modifying, finalizing and attaching signed final CRs to Final MedComm documents or reviewing Project Team-created CRs
- Updating, modifying and maintaining the MedComm database and applicable document tracking spreadsheets to track document progress and study details
- Providing guidance to assigned Project Teams and Project Team members
- Providing language updates, as required, for all MedComm document templates as needed
- Creating Final Effective documents
Maintains quality service and departmental standards by:
- Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
- Updating department SOPs and Work Instructions as needed
- Assisting in establishing and enforcing departmental standards
- Contributes to team effort by:
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Participating in internal training activities
- Helping others to achieve results
- Performing other duties as assigned
- Maintains Technical and Industry Knowledge by:
- Staying up-to-date on response criteria publications posted by Medical Communications
- Participating in Medical Writing Training activities, including creating/reviewing training modules
- Attending and participating in applicable company-sponsored training
- Bachelor’s Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred
- 1+ years medical writing experience preferred, but is not required.
- 2+ years experience in pharmaceutical/clinical/imaging research preferred
- Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing
- Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)
- Understanding and knowledge of medical and/or clinical trial terminology desired
Additional Skill Set:
- Ability to work in a group setting and independently; ability to adjust to changing priorities
- Excellent attention to detail and orientation toward meticulous work
- Strong interpersonal and communication skills, both verbal and written
- Strong documentation and organizational skills
- Ability to project and maintain a professional and positive attitude
- Organization and time management skills for managing multiple projects concurrently
Other: Computer work for long periods of time
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation