Job Description

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.

Apex has an opportunity for an Director of Data and Biostatistics . For applicants who are interested in thisopportunity, send your updated resume toMike Konjoian, Account Manager, at [email protected] .

Here are the details:

Position: C linical Research Associate

Location: Remote

Project Duration: 10 Months w/ potential for extension/conversion

Rate: Negotiable Based on Experience

JOB DESCRIPTION

The Clinical Research Associate (Monitor) is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required.

Responsibilities:

• Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements.

• Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.

• Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent and support Institutional Review Board (IRB) submissions.

• Train site staff on protocol requirements, source documentation, and case report form completion.

• Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.

• Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date.

• File site related documents real-time to ensure Trial Master Files are complete and accurate at all times.

• Provide study specific information and support report validation activities as requested for clinical study reports.

• Participates in team meetings and document meeting minutes and tracks action items.

• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.

• Performs other duties as required (note, all listed tasks may not be conducted depending on study status and roles of other internal and external team members).

Education and Experience:

• B.S. or B.A. and/or an equivalent combination of education or experience.

• Minimum of 3 years of experience directly related to the execution of clinical research studies.

• Available to travel (up to 60%) on short notice and independently manage travel schedules.

• Must have analytical skills, be detail oriented and have good interpersonal skills.

• Knowledge of agency guidelines and requirements.

Skills/Competencies:

• Effective written and verbal communication skills.

• Ability to communicate at all levels of an organization.

• PC skills; word processing, spreadsheet, database, Internet search and utilization.

• Flexible and able to work in a fast-paced environment.

• Team player.

• Ability to organize and judge priorities.

• Excellent ability to generate and maintain accurate records.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.


Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.

Job Tags

Local area, Remote work, Flexible hours,

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