Last Updated: October 25, 2017
We currently have Field Clinical Research Associate (Field Monitor) opportunities available in the Central and Midwest regions.
The Field Clinical Research Associate (Field Monitor) performs on-site visits, such as Qualification, Site Initiation, Interim Monitoring and Study Close-out Visits, in accordance with the Monitoring Plan. Responsibilities include ensuring the site study staff conduct the study in compliance with the currently approved protocol/amendment(s), Baim’s Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH)/Good Clinical Practices (GCPs), and applicable regulatory requirements, performing source document verification, query resolution, collaborate with in-house Clinical Research Associate (CRA) team, ensuring regulatory documents and the Investigator Site Files (ISFs) are complete and current. May serve as a mentor and coach to SM staff. Field Monitor position is primarily a remote position and is expected to work collaboratively with internal and external project team members.
Primary Duties and Responsibilities:
- Responsible for overall on-site monitoring activities of assigned clinical sites.
- Independently conduct all types of monitor visits onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote visits as needed, in accordance with Monitoring Plan.
- Participate in the site/investigator selection system/process.
- Perform source document verification/review in accordance with Monitoring Plan.
- Perform drug and/or device accountability.
- Collect and submit regulatory documents as necessary.
- Review ISF and resolve noted deficiencies in a timely manner.
- Perform Informed Consent Form (ICF) reconciliation, to ensure all subjects have signed the correct ICF version.
- Query generation and manage to resolution.
- Identify and resolve site level Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with Lead CRA and/or in-house CRA
- TMF maintenance
- Update and maintain CTMS, ensure that it is up-to-date and accurate
- Provide site support, communication and coordination to assure accurate and timely completion of all contracted activities:
- Effectively perform Protocol and other study training to investigator and site study staff.
- Schedule and conduct visits in accordance with Monitoring Plan
- Collaborate with Study Team during start-up activities.
- Complete visit reports, confirmation letters, and follow-up letters on time, in accordance with Monitoring Plan and/or Baim SOPs and Guidelines.
- Close out action items identified during site visits, in a timely manner.
- Knowledge of pertinent study milestones.
- Establish a strong working relationship with site study staff and Baim project team members.
- Responsible to schedule visits with site study staff and conduct follow-up of action items and queries.
- Complete expense reports per Baim expense guidelines.
- Co-monitor as needed.
- Attend and participate in investigator and coordinator meetings.
- Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.).
- May be requested to attend internal team and CRA meetings.
- Baim Field Monitor Employees may be requested to perform other duties, such as mentor and coach staff, Lead CRA role, conduct remote visits, track and report study site progress, provide ongoing additional site management support as assigned, through project completion.
- Demonstrate a high working knowledge of internal SOP’s, FDA/ICH guidelines to GCP’s and regulatory compliance.
- Demonstrate effective leadership skills.
- Effective communication skills.
- Must demonstrate in-depth knowledge of the study protocol.
- Maintain an effectual working relationship with Sponsors, the Principal Investigator, Site Study Staff, and Baim team members.
- Work independently and in a team environment.
- High level of attention to detail and work in an organized manner.
- Effective ability to multi-task and work in a fast pace environment.
- Knowledgeable with common software packages (Word, Excel, PowerPoint, Outlook) and Internet use.
- Knowledgeable of Clinical Trial Management System.
- Knowledgeable of Electronic Data Capture System (e.g InForm, eCOS, IWRS).
- Ability to quickly learn new software packages.
- Required: BS Degree in science/health related field, or nursing experience, or related experience.
- Preferred: Nursing
- Preferred: Certified Clinical Research Professional (CCRP) or equivalent and/or Certified Clinical Research Associate (CCRA)
Years of related experience:
- Required: At least 2-4 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 2-4 years of independent clinical monitoring.
- May be expected to conduct 8-10 visits per month, although percent of travel is dependent on study specific need. Travel will be required, to attend Investigator Meetings, Site Visits, and Professional conferences.
To apply for this position, please submit a cover letter and resume.