Seeking a Clinical Research Associate to join a growing CRO! This position is hybrid in Dedham, MA. Responsibilities:Monitoring
Design, implement and monitor clinical trials
Design/update data collection forms (CRFs) and informed consent forms
Assist sites in getting IRB approvals for trial
Point of first contact when site has inquiries regarding trial/conduct of trial
Address and assist with enrollment issues
Coordinate movement of laboratory samples and resulting data when central laboratory facilities are used
Oversee maintenance of Trial Master Files
Plan requirements for clinical trial materials throughout study life, order/send study materials to site as necessary; coordinate timely shipment of clinical supplies to sites
Performing site visits; monitor the trial through its duration, ensuring that trial is compliant with current protocol and in accordance to GCP
Monitor site performance and adherence to protocols
Review case report forms to verify data entered on the CRFs is consistent with source documents
Write up visit reports and follow up with site on unresolved issues
Closing down trial sites upon completion of trial
Participate in departmental planning sessions and calls and meetings to review progress of ongoing trials
Respond to company, client and federal regulatory requirements/audits
Auditing
Performing internal/external audits of clinical trials
Performing systematic and independent examination of trial related activities and documents
Performing audits of clinical trials to ensure compliance with federal and state laws and regulations
Conducting audits to assure compliance with study or sponsor SOPs, GCP, GDRP/HIPAA, and expectations for data accuracy and completeness
Tracking, collecting and reporting audit findings
Working with the study team to identify root causes and provide corrective and preventative action plans when noncompliance is found
Providing timely feedback by means of the audit report and ensuring timely completion of all audit related activities
Data Management
Ensure that data from case report forms are entered into the database correctly and in a timely manner
Decide on how best data should be entered and communicating decision with team
Assist with data query resolution
Ensure that data is clean and accurate
Testing databases; logging bugs
Review all site regulatory documentation to ascertain that they are current
Maintain trial master files and ensure that information is current
Deciding on naming and filing conventions for master files and communicating to team
Ensure that all monitors are apprised of data/regulatory documents needed from site
Additional Skills & Qualifications:
2-3 years experience as a CRA
Bachelor's Degree is required
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.