Clinical Research Associate - Medical Device

Description

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

• Establish and maintain good rapport with sites

• Liaise with investigator/site personnel on conducting the trial

• Point of first contact when site has inquiries regarding trial/conduct of trial

• Monitor for problems and proactively institute solutions

• Set up trial sites by ensuring each site has all the trial materials to start enrollment and perform procedures

• 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

• Train site staff on the protocol

• 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

• Collect case report forms

• Write up visit reports and follow up with site on unresolved issues

• Maintain site tracking records

• Assist sites in liaising with the internal review board

• Review all SAEs to ensure that all necessary parties are notified

• Ensure all unused supplies are accounted for

• 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

• Furnish client with requested data in a timely manner

• Ensure that the rights and well-being of human subjects are protected

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

Qualifications

• Full time onsite

• Pharma, biotech, medical device experience required

• Medical device preferred

• TMF experience

• Studies are in the US and travel for this would be 1-2 trips/ month within US

• Medidata and other EDC experience required

• 2-3 years of CRA experience and 4-5 overall years of experience

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 actalentaccommodation@actalentservices.com for other accommodation options.