Clinical Research Associate II
CLINICAL RESEARCH ASSOCIATE
General Description of the Job Class
Develop, coordinate, and implement monitoring strategies essential to the successful management of clinical trials research conducted by Investigators.
Duties and Responsibilities of this Level
- Review and demonstrate understanding of various clinical trial protocols.
- Participate in site selection and training site personnel regarding the trial; perform site routine monitoring of the trial and follow-up to ensure identified deficiencies are corrected; travel as required to accomplish responsibilities.
- Coordinate the assessment of the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.
- Conduct site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, case report form completion and retention requirements, drug accountability procedures, serious adverse events (SAEs), reporting procedures and overall management.
- Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of Case Report Forms, source documents, medical records, and regulatory documents.
- Follow established guidelines to ensure consistent monitoring of key clinical trial components. This includes but is not limited to investigational agent handling and documentation, timely and accurate data submission, regulatory compliance, and patient care.
- Provide feedback to assist sites which includes summary of overall site operations, detected deficiencies and corrective action needed; follow- up with sites until deficiencies are resolved.
- In addition to the work performed under the CRA I role, the CRA II will also be responsible for the following: Develop plans, tools, documents, and standard operating procedures for monitoring clinical trials.
- Independently identify when monitoring visits are required based on protocols and policies.
- Independently perform assessments of investigative site, and conduct various monitoring visits as detailed above.
Minimum Required Qualifications at this Level
Education: Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (BSN), Physician Assistant (PA), Nurse Practitioner (NP), or Pharmacist plus three years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of three years closely related research experience.
Experience: Required experience outlined in the education section
Degrees, Licensure, and/or Certification: Driver's license may be required
You may not recognize the name, but you know who we are. You know us as innovative outsourcing and resourcing leaders from The Woolf Group, Trio and Novella Clinical Resourcing. Once again, Betsy Brown and Jean Hendrickson have teamed up to bring innovative, cost-effective and highly collaborative resourcing solutions to meet the growing challenges of CROs and Sponsors in research and development today, as well as fascinating opportunities to clinical research professionals looking to advance their career.
Wed, 9 Aug 2017 13:19:19 PDT