Benefits:

Competitive salary

Dental insurance

Health insurance

Paid time off

Vision insurance

Job description

Clinical Research Associates of Central PA is seeking a Clinical Research Site Manager who will deliver and organize work plans with a team of research site staff in support of clinical trial research goals. Activities include training and managing clinical and data entry personnel regarding specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance.

Qualifications

The candidate must have background and experience in research protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level

The position requires the ability to make independent judgments and to act on decisions on a daily basis, the ability to work for long periods of time without direction, and the ability to prioritize one’s own work and work of others

Understands and can apply knowledge of clinical trial designs to trial execution

Responsibilities

Clinical Research Site Manager will deliver to and organize work plans with site staff

Activities include training and managing clinical and data entry personnel regarding specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance

The Site Manger will have the critically important responsibility for establishing early lines of communication with the clinical team as new studies are identified, selected and prepared for activation

Will be integral to propel accelerated timelines during the trial start-up cycle and then during subject accrual, assuring that monthly enrollment goals are met each month across all clinical sites.

Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.

Ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.

Oversee site compliance with investigational products, reporting or safety events and contracting.

During trial implementation, the Site Manger will oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.

Benefits

Salary is commensurate with experience

Health insurance

Dental insurance

Vision insurance

Simple IRA

Paid time off