Clinical Research Associate - (All therapeutic Areas)
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A research organization with a 30+ year history of delivering one of the best customer experiences in the industry, and we’re looking for talented individuals who are as dedicated to customers, teams, and quality as we are.
The Clinical Research Associate II (CRA II) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines; CRA II conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation, responsible for ensuring the data remains audit ready and able to pass an audit. The CRA II will be responsible for supporting study team management by providing input into monitoring tools and process development as well as training for newly assigned project CRAs.
Desired Skills and Experience
- 5+ years on-site monitoring experience within CRO, pharmaceutical or biotechnology industry; at least 5 years monitoring commercial studies preferred
- BA/BS, preferably in a Life Sciences, Nursing or Pharmacy
- Broad range of therapeutic experience
- Superior written and verbal communication skills
- Demonstrated ability to train, mentor and lead clinical research staff
- Ability to constructively interact directly with sponsor personnel
- Ability to travel 65-75%; Office based in Chapel, NC
Responsibilities and duties include, but are not limited to:
· Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV). Participate in the site selection process with oversight from the Clinical Team Lead role
· Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
· Contribute to the development of protocols, study tools, and materials as well as documentation for clinical trials Provide mentoring, training, and co-monitoring of junior clinical team members
· Develop and maintain effective working relationships with clinical sites and within as well as ensure communication of project goals and critical requirements
· Participate in the Clinical Operations community at by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials. Perform both onsite & remote monitoring and study closure activities across multiple protocols
***2 years minimum experience required. *** Salary $75K – 90 K (NEGOTIABLE, Based on Experience) ***Be willing to relocate to the RTP area and live within 1 hour of commute.
Applicants must live within a 60 minute commute of a US metropolitan airport.
For further information about this role and to be considered as an applicant please get in touch with Jasmine Boota at firstname.lastname@example.org or 919-838-7478
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