Telecommute Jobs in Durham, NC

Job Title

Pay Range $30.22hr - $35.22hr

Requirement/Must Have:

• 5+ years of experience in a healthcare environment or equivalent combination of education, training, and experience.
• Strong verbal and written communication skills.
• Ability to communicate effectively with stakeholders.

Responsibilities:

• Review documents for completeness, consistency, and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
• Review, track, and follow up the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents.
• Execute the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.
• Prepare and manage site documentation; review and negotiate site documents and contracts with sites and sponsors; maintain, review, and report on site performance metrics.
• Serve as the primary point of contact for investigative sites; track completion of appropriate documents for sites; ensure contracts are fully executed; and establish project timelines.
• Perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines.

Skills:

• Good interpersonal skills.

Education and Experience:

• Bachelor's Degree in Life Sciences or a related field.
• 1-3 years of clinical research or other relevant experience; or equivalent combination of education, training, and experience.