Regional Clinical Research Associates - Perm positions across the US!
Our client, is a specialty CRO that utilizes a broad expertise across Women's Health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwide.They are seeking several experienced CRAs to join their team. They are specifically looking for Northwest, Midwest, Northeast and Southeast metro areas.
The CRA will be responsible for performing site monitoring activites for assigned clinical studies in accordance with the Task Order, protocol, standard operating procedures (SOPs), ICH guidelines and all applicable regulatory requirements.
Major Responsibilities include:
- Responsible for performing on-site monitoring visits to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirements
- Assists with investigator identification, evaluation and selection activities, as requested
- Performs pre-study site visits (PSSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) in accordance with the Task Order, protocol, study-specific monitoring plan, applicable SOPs, ICH guidelines and all applicable regulatory requirements.
- Conducts source document verification, performs drug accountability and reviews the investigator site file during on-site monitoring visits as outlined in the study-specific monitoring plan
- Responsible for building strong, collaborative relationship with investigators and staff at assigned clinical sites.
- Collaborates with assigned sites to develop and maintain a site-specific recruitment and retention plan; responsible for regularly reviewing this plan with the site during monitoring visits and ensuring the timely implementation of contingency plans ensure recruitment goals are met
- Serves as a point of contact for study-related questions and issues from study sites
- Responsible for providing study-specific training to the clinical site staff
- Generates confirmation letters, monitoring visit trip reports, and follow up letters in a timely manner for each monitoring visit
- Generates and assists in the closure of data queries, as appropriate
- Assists in the collection of follow-up data for serious adverse events, as requested
- Proactively identifies, documents, and assists in the resolution of issues relating to subject recruitment, study data quality and study conduct at assigned study sites
- Partners with Inhouse CRAs (IHCRAs) to ensure seamless management of assigned clinical sites. Frequently communicates with IHCRAs to share updates on assigned sites, discuss site issues and concerns, and agree actions for resolving issues and deficiencies at the site. Works with the IHCRAs to prepare for and follow-up of on-site monitoring visits by participating in pre-visit calls with IHCRAs and taking responsibility for the resolution of issues identified during on-site visits that must be handled on-site.
- Attends project team meetings, departmental meetings and meetings with line manager
- Performs tasks in internal and client-specific systems, as required
- Other responsibilities as assigned
Additional Responsibilities of CRA II
- May assist with creation of study-specific documents
- May conduct co-monitoring visits with junior level CRAs
- May participate in departmental initiatives
Additional Responsibilities of Senior CRA
- May review trip reports for more junior CRAs
- May conduct internal training for more junior CRAs
- May be responsible for the preparation and presentation of information during Investigator Meetings
- May be requested to contribute to Request for Proposals (RFPs)
- May be requested to lead or contribute to company initiatives
- BS/BA degree (or its international equivalent) preferably in a scientific or health-related field, nursing qualification or relevant experience
- 1 to 2 years of clinical research monitoring experience (including experience conducting pre-study, initiation, interim monitoring and closeout visits)
- Prior experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, regulatory compliance, and study coordination
- Working knowledge of medical terminology, FDA regulations and ICH guidelines.
- Strong interpersonal and organizational skills with strong attention to detail
- Demonstrated ability to meet timelines and multi-task to complete multiple deliverables in parallel.
- Strong computer skills, including a solid understanding of Microsoft Office Suite. Demonstrated ability to learn other applications.
- Excellent written, oral communication, and organization skills
- Ability to work with minimal supervision
- Ability to read, write and speak fluent English; fluent in host country language.
Additional requirements of a CRA II:
- A minimum of 3 years of clinical research monitoring experience (including experience conducting pre-study, initiation, interim monitoring and closeout visits)
- Excellent interpersonal and organizational skills with strong attention to detail
- Demonstrated ability to mentor and train others
- Ability to negotiate and problem solve
Additional requirements of a Senior CRA
- A minimum of 5 years of clinical research monitoring experience (including experience conducting pre-study, initiation, interim monitoring and closeout visits)
Special Position Requirements
- Ability to travel at least 50%
- Must obtain and maintain a valid driver's license issued by the state of residence
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.
Fri, 15 Sep 2017 12:50:08 PDT