1) Monitor and support administration and progress of clinical trials conducted by the medical device company
2) Assist manager on a variety of ongoing projects
3) Conduct site initiation visits for the purpose of training site personnel about the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion, record retention requirements, device accountability procedures, serious adverse event (SAE) reporting procedures and overall site management
4) Conduct interim monitoring visits to verify the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedures through review of CRFs, source documents, medical records and regulatory documents
5) Conduct close out visits for the purpose of study closure to ensure appropriate documentation between site file and Master Files
6) Provide feedback to assigned sites which includes a summary of overall site functioning and detected deficiencies and corrective action required
7) Follow-up with sites until deficiencies are resolved
8) Monitor the clinical progress for all assigned sites, in addition to providing site management through frequent contact with the site staff by telephone, e-mail and monitoring visits
9) Provide ongoing clinical trial support to the Clinical Operations Manager and take on specials projects as assigned
10) Lead special projects related to the trial as assigned by management
11) Develop and revise procedures related to clinical operations as required
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in Clinical Research
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.