Location: Regional/Mid-Atlantic, USA
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
Are you an experienced Clinical Research Associate who would like to broaden your therapeutic experience to include Oncology? Would you like to be in a position that will allow you to grow your career as a CRA ? If so, this position will allow you to do both! Our client is located in the Northeast and is seeking a Clinical Research Associate in the Mid-Atlantic region (or based around a major airport hub) for a home-based position.
The role of the Clinical Research Associate is to support project team members in activities associated with the set up and running of a clinical trial. Responsibilities may include but not limited to: May help manage one or more clinical trials with protocol activities to include: Serve as the main point of contact and coordinate day to day activities for all assigned clinical operational functions. Under the supervision of clinical trial manager, helps 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, clinical field force, vendors, and personnel as appropriate. Coordinate day-to-day activities of clinical trials. May help create/track detailed project plans for assigned clinical trials. Problem-solve specific clinical trial issues. Participate in the design and preparation of clinical trial documents such as protocols and case report forms. May participate in the identification, evaluation and selection of clinical investigators. May train and mentor less experienced CRAs, CTAs and new team members. May help manage external vendors. Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable. May assist in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as, regulatory authority inspections. 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. Provided administrative support for project teams including: email communication and newsletters per contract specifications. Assist in identifying and implementing best practices and continuous improvement plans within the company. Must be eligible to work in the U.S. Ability to lift 15 pounds. Required Experience and Qualification Clinical Monitoring experiences in the Pharmaceutical/device Industry or equivalent is a plus. Knowledge of medical device regulatory requirements and documents, device accountability. Bachelors in scientific discipline or any relevant and qualifying medical training, RN or health care professional. Past experience working in both a CRO and/or sponsor a plus. Ability to travel (domestic and internationally): up to 50% of the time. Knowledge of FDA, ICH and local regulations/ guidance. Good communication and organizational skills. Knowledge/Skills: Fluency in English (verbal and written) and excellent communication skills. Strong critical thinking and problem solving skills. Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines. Excellent organization and record keeping skills. Ability to maintain excellent working relationship with a broad range of trial staff. Ability to work well in a team environment and also independently without significant oversight. Flexibility in work hours and readiness to travel on a routine basis. Advanced computer literacy. Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Wilmington, North Carolina, USA
2520 Independence Blvd, Suite 202, Wilmington, NC 28412, USA
|Tel:||+1 910 338 4760|
|Fax:||+1 888 301 2627|
|Website:||Visit Our Web Site|
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