BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Clinical Research Assistant to work for a leading San Diego biotechnology company.
Sr. Clinical Research Assistant
The Temporary Clinical Research Assistant, Clinical Development and Medical Affairs, is responsible for creating and maintaining the clinical Central Files and providing other related support to the activities being conducted by members of the Clinical Development and Medical Affairs department.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Create, organize, and maintain the CDMA Central Files.
Ensure that a hard copy of documents and reports and other essential documents (e.g., protocols, amended protocols, and CSRs, etc.) are filed in CDMA Central Files and scanned on the Clinical network drive on the company server.
Provide secondary review of essential documents (e.g.1572s, Investigator CVs, Financial disclosure forms, etc.) as needed.
Create or obtain, organize and file hard copies of clinical documents for clinical trials associated with the company.
Interface with clinical investigative sites to obtain, track, and file study site regulatory and other essential documents.
Organize and maintain Clinical directories and files on Clinical network drive on the company server.
Upload, save, and organize digital photographs and videographs for various trials on the Clinical network drive on the company server.
Create PDF files of documents required for various reports, such as clinical study reports (CSRs), as needed.
Perform limited data entry on an occasional basis, as needed.
Create Study Binders and clinical template documents.
Create study labels (e.g. drug labels) and patient/subject tools or other material as needed.
Create and maintain tracking logs.
Create and maintain vendor POR and track ongoing invoices
Participate in creation and review of CDMA SOPs.
Maintain CDMA SOP tracking log.
Assist in QC process for various clinical documents.
Format documents as needed.
Update and maintain CDMA protocol number tracking log.
Update and maintain clinicaltrials.gov account.
Create, as needed Power Point Presentations.
Order and ship clinical supplies as needed.
Fax, mail, and Fed Ex documents as needed.
Perform responsibilities under pressure and tight timelines, with the ability to juggle multiple concurrent projects and tasks.
Demonstrate attention to detail.
Demonstrate creative and effective problem solving skills.
Prioritize and provide status updates of deliverables.
Effectively organize and manage time.
Demonstrate good communication and interpersonal skills.
Comply with company objectives, policies and procedures, and quality assurance program.
Perform other duties as may be assigned.
High school level diploma required, BA/BS in one of the life sciences preferred
Minimum of 1 year of experience working the clinical or medical affairs department of a CRO, biotech, or pharmaceutical company
Strong clinical background or experience preferred
Knowledge of Good Clinical Practice strongly preferred
Prior experience with a small entrepreneurial biotech or pharmaceutical environment is a definite asset.
BioPhase Solutions - 18 months ago