The Baim Institute for Clinical Research is a leading, non-profit academic research organization (ARO) that delivers insight, innovation, and leadership in today’s dynamic research environment. We collaborate with the world’s most highly respected researchers from renowned institutions to design and run clinical trials – and we are fiercely committed to finding creative solutions and delivering timely results that help advance health and quality of life around the world.
About the Position:
The Clinical Research Associate serves as the primary site contact from Site Initiation Visit (SIV) through study close-out. Responsibilities include, ensuring the 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 remote and/or on-site monitoring activities as assigned, performing source document verification, query resolution, ensuring regulatory documents and Trial Master Files (TMFs) are current, and may assist with Study Start Up (SSU) activities as assigned.
The Clinical Research Associate must:
- Have a minimum of 6 months on-site monitoring experience; NE
sites - May perform remote visits and/or on-site visits
- Have site management or relevant clinical trial experience - Opportunity to learn Clinical and Project Leadership skills
- Live in or relocate to the Greater Boston area; this position is on-site
- Coordinate and perform with guidance of Management and experienced team members, site management and monitoring activities as related to the conduct of all phases of pharmaceutical, biotechnology and medical device clinical trials:
- Serve as primary point of contact and support for site post SSU (from site transition) through study close-out.
- May perform remote visits and/or on-site visits in accordance with the study Monitoring Plan, including oversight of site recruitment and consenting process.
- Maintain communications on a regular basis with the investigator and site staff.
- Train investigative site personnel on protocol and procedures.
- Participate in ongoing study training
- If qualified and trained, complete and review visit reports, confirmation letters, and follow up letters on time, in accordance with Monitoring Plan and/or Baim Institute’s SOPs and Guidelines.
- Site compliance reporting of Serious Adverse Events (SAEs) and protocol deviations
- IND safety report management (e.g. MedWatch, CIOMS, SUSAR, UADE)
- Support the Corrective and Preventative Action (CAPA) process for assigned sites through resolution in a timely manner.
- Resolve open action items, for assigned sites, including those identified from monitoring visits.
- Ensure site data entry compliance per study requirements.
- Perform query resolution activities through completion in collaboration with DM.
- Collect, maintain, and track essential regulatory documents, post site transition, on an ongoing basis, including expired documents and updated or amended documents.
- Distribute amended study materials, such as protocols and ICFs, to sites and manage associated LIRB/CIRB and ICF activities
- Finalize site payments with project assistant (PA)
- Maintain ongoing communication with study team and Field Monitors.
- Initial and ongoing coordination and distribution of equipment and supplies
- May be requested to attend on-site visits, with designated SM staff member
Lead CRA or designated lead with project planning activities, as required:
- Development of study-related materials, such as Monitoring Plan, Delegation of Authority log, Investigator Study File, Source Document Worksheets, Drug/Device Accountability Logs, site recruitment tools.
- Assist team as needed with SSU activities, such as:
- Perform site and/or investigator selection activities working with SM team members and/or Sponsor to identify and screen qualifications of potential investigative sites
- Collect regulatory documents
- Negotiate the Informed Consent Form (ICF) and assist with IRB submissions
- Meet site activation timelines as agreed with the Sponsor
- TMF responsibilities, include:
- Maintain and perform Quality Control (QC) checks of the TMF in accordance to the TMF Plan, post site transition
- Review and submit updated/amended site documents to the TMF on an ongoing basis.
- Resolve TMF audit findings
- Ensure Clinical Trial Management System (CTMS) is current and accurate on a regular basis, including site contact list, IRB chairperson information, tracking documents and screening logs.
- Collect and review enrollment screening logs
- Work closely with other Baim Institute’s departments to ensure that overall study timelines are met, as required, such as:
- Support academic lead activities as assigned.
- Organize and prepare trial related material and presentations for investigator meetings and/or webinars
- Perform or assist with the development and/or review of study newsletters and frequently asked questions log
- Participate in internal and external meetings
- May be called upon to join departmental and/or company committees
- Demonstrate knowledge of internal SOP’s, Food and Drug Administration (FDA)/ICH guidelines to GCP’s and regulatory compliance.
- Must demonstrate in-depth knowledge of the study protocol.
- Maintain an effectual working relationship with Sponsors, the Principal Investigator (PI), Site Staff, and Field CRA.
- Work independently and in a team environment.
- Attention to detail and work in an organized manner.
- Ability to multi-task and work in a fast pace environment.
- Knowledgeable with common software packages (Word, Excel, PowerPoint, Outlook) and Internet use.
- Familiarity with CTMS.
- Familiarity with Electronic Data Capture (EDC) System
- Ability to quickly learn new software packages.
Required: Bachelor’s in Science/Health Related Field and/or BA
Yrs. of related experience:
Required: 1-3 years of site management or relevant clinical trial experience.
Occasional travel may be required to attend site visits, investigator and coordinator meetings, and professional conferences. Amount of travel required is study-dependent.