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Director, Human Resources at Baim Institute for Clinical Research
The Sr. Clinical Research Associate/Field Monitor Contractor performs remote and 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 Institute’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. Regional CRA position is a remote position who is able to travel regionally up to 60% and is expected to work collaboratively with internal and external project team members.
Primary Duties:
- Responsible for overall on-site and remote 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.
- Perform source document verification/review in accordance with Monitoring Plan.
- Collect, review for appropriate content and submit regulatory documents as necessary.
- Review ISF and resolve essential regulatory document 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 quality issues and implement Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with SM Lead and/or in-house CRA
- Comply with Trial Master File (TMF) document submission timelines
- 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 Institute’s 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 Institute project team members.
- Responsible to schedule visits with site study staff and conduct follow-up of action items and queries.
- Co-monitor as needed.
- Attend and participate in investigator and coordinator meetings.
- Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.).
- Attend Baim CRA meetings.
- Demonstrate a high working knowledge of internal SOP’s, FDA/ICH guidelines to GCP’s and regulatory compliance.
- Demonstrate effective leadership 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 Institute 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)
- Knowledgeable of Clinical Trial Management System.
- Knowledgeable of Electronic Data Capture System (e.g InForm, IBM Clinical, iMedNet, eCOS, IWRS).
- Ability to quickly learn new software packages.
Requirements:
Education:
Required: BS Degree in science/health related field, or nursing experience, or other clinical trial related experience.
Yrs. of related experience:
Required: At least 5-8 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 8 years of independent clinical monitoring.
Travel:
May be expected to conduct 2-4 visits per month, travel regionally up to 60%, although percent of travel is dependent on study specific needs.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Part-time
Job function
Job function
Project Management and ResearchIndustries
Non-profit Organizations, Pharmaceutical Manufacturing, and Research Services
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Pension plan
Tuition assistance
Disability insurance
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