The Clinical Research Associate (CRA) will work under the supervision of project lead or clinical study manager to help facilitate information flow between all members of the clinical operations / clinical trial site team, including in-
house departments, clinical project team members, external CRO or contracted members, vendors, and other personnel as appropriate.
Provide general support to Clinical and Regulatory Project Teams which may include logging, tracking and filing of study paperwork and regulatory documents;
maintain and track invoices, execute study mailings and create study materials, assist with postings.
The Research Associate will support coordination of day-to-day activities of clinical trials including imaging activities and may help create and track detailed project plans for assigned clinical trials.
Assist with review and evaluation of clinical data and study narratives and assist with Data management activities as needed.
The Research Associate will also assist with the preparation and review of case report forms, protocols, investigator's brochures, instructions for use, Standard Operating Procedures (SOPs), study operations manuals, site and FDA annual reports and develop and maintain relationships with outside consultants and vendors as required for each protocol.
May train and mentor less experienced CRAs, CTAs and new team members on ICH GCP and study protocol.
Perform site initiations, monitoring and close-out visits to regional clinical sites or at problem sites and interfaces -
externally with clinical investigators, investigational sites and project vendors.
Other duties :
Receive, review, track / inventory and filed all documents pertaining to applicable clinical research studies.
Prepare, maintain, and return / archive project master files as applicable.
Perform project master file reviews as outlined in project specific plan.
Request, manage, distribute and track study supplies.
Update and maintain study-specific trackers and systems under direction of Project Lead.
Coordinate, provide set up, and attend project meetings including : internal, CRA, client meetings and presentations.
Assist with distribution of documents.
Assist in identifying and implementing best practices and continuous improvement plans within the company.
Under minimal supervision, ensures compliance processes and relevant SOPs are followed and updated as needed.
May assist in the preparation and follow-up of in-house and on-site sponsored clinical quality audits, as well as, regulatory authority inspections.
Possesses knowledge of GCP and local country regulatory requirements; Should have good communication skills; Should have attention to details;
Should be able to understand and execute the allocated task
Experience : 1-2 years
Educational Qualifications : PhD / Medico
ref : biojoby.com)