Current Opening: Clinical Trials Administrator
Myoscience has an exciting opportunity for a Clinical Trials Administrator located in our Fremont, CA headquarters.
As the Clinical Trials Administrator, you are responsible for coordinating activities of associates and investigators to ensure compliance with protocol and over-all study objectives especially during the start-up and initiation phases of trial.
You will also generate and review regulatory documents as required in study start-up activities and throughout. In addition, you will be responsible for multiple projects and must work both independently and in a team environment. In your role, you will assist in reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific PI/CRC/CRA training.
- Provide general support for the clinical affairs team.
- Maintain spreadsheets for tracking of essential documents, study enrollment, study visits and site payments.
- Set up and maintain Trial Master Files (TMF) and Site Master Files (SMF) (both electronic and hard copy)and responsible for filing and maintaining up to date study documents.
- Scanning and indexing of study documentation.
- Construct case report form (CRF) binders and source document folders.
- Packages and sends documents and supplies to clinical trial sites and vendors.
- Aid in vendor management/support as necessary.
- Preparation of documentation for archiving.
- Ensure implementation in accordance with appropriate SOPs, ICH/GCP guidelines and federal, state and/or local regulations.
- May serve as a study contact during trial conduct including qualification, initiation, and maintenance phases.
- Provide study managers with routine updates regarding the status of regulatory documents or other reports as deemed necessary.
- May assist in preparation and coordination of Investigator Meetings.
- Submit clinical department documents to internal document control system and track approval of document.
- Create, obtain approval for and submit invoices for payment.
- Maintain department financial accruals.
- Perform other related duties and tasks as required.
- BS/BS with 1-2 years trial administration experience preferably in medical device.
- Must have knowledge in reference to good clinical practices, regulations, and standard operating procedures.
- Excellent interpersonal and organizational skills and attention to detail.
- Sound knowledge of medical terminology and clinical study process.
- In depth therapeutic and protocol knowledge as provided in company training.
- Computer literacy, proficiency in MS Office.
- Intermittent travel.
If you are interested in joining our team, please send your resume to email@example.com.