Assistant CRA (ACRA) - Northeast & Southeast US

Join a global team that has supported the top 50 pharmaceutical companies and over 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years. As an Assistant Clinical Research Associate, you’ll perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead, providing support with site preparedness, logistical support to the monitoring process, and assisting with site management and remote monitoring in accordance with SOPs and regulatory guidelines. Limited site contact activities may be assigned during study start-up, site management, recruitment, and close-out phases.

Preferred candidates will have a minimum of 6 months of clinical trials or clinical research exposure. Due to future travel requirements, candidates must live within 60 miles of a major airport.

About the role

You’ll provide in-house and remote support for clinical research activities, ensuring compliance with study protocols, SOPs, and regulatory guidelines.

Responsibilities

• Complete study and site management activities as defined in the task matrix and as directed for assigned studies.
• Complete and document study-specific training; orient and train on study-specific systems.
• Provide in-house support during pre-study assessments and with pre-study assessment waivers.
• Customize Site ICF with site contact details as needed.
• Perform remote review of EMR/EHR checklists and support collection of applicable assessments.
• Verify document collection and RCR submission status; update site EDL and verify site information.
• Review patient-facing materials and translations as directed.
• Support site staff with vendor-related qualification processes where applicable.
• Ensure system access is requested, granted, and revoked for relevant site staff during pre-activation and throughout the study.
• Follow up on site staff training as applicable.
• Coordinate and support logistics for IM attendance as directed.
• Maintain vendor trackers as directed.
• Coordinate study/site supply management during pre-activation and throughout the study.
• Support Essential Document collection, review, and updating in systems.
• Follow up on missing study vendor data such as ECGs, lab samples, and e-diaries as directed.
• Support ongoing remote review of centralized monitoring tools as directed.
• Support site payment processes by coordinating with various functional departments and sites.
• Support system updates and reconciliations; follow up on site invoices throughout the study period.
• Perform reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports.
• Verify document collection status in company systems and drive action for missing, incomplete, or expired documents.
• Perform other assigned site management tasks as directed by the CRA and per the Task Matrix.
• May perform a specific role profile for FSP opportunities according to client requests.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

Requirements

• Completed Bachelor’s degree in a life science discipline or related field, or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• Minimum of 6 months of clinical trials or clinical research exposure (preferred).
• Must live within 60 miles of a major airport due to future travel requirements.

Qualifications

• Bachelor’s degree in a life science discipline or related field, or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• 0 to 2 years of previous experience that provides the knowledge, skills, and abilities to perform the job. In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

Skills

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations, and company procedural documents.
• Effective oral and written communication skills.
• Excellent interpersonal and customer service skills.
• Good organizational and time management skills with strong attention to detail; proven ability to handle multiple tasks efficiently.
• Proven flexibility and adaptability.
• Ability to work in a team or independently as required.
• Well-developed critical thinking skills, including root cause analysis and problem-solving.
• Proficient computer skills with good knowledge of MS Office; ability to learn and use appropriate software.
• Leverage modern technology when applicable.
• Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards.
• Excellent English language and grammar skills.

Environmental Conditions

• Work is performed primarily in an office or home office environment.
• Occasional travel to clinics or hospitals may be required.
• Exposure to electrical office equipment.
• While this role does not involve regular travel, promotional opportunities in the CRA career track may require frequent travel (60-80%).

Pay

The salary range for this position based in Georgia is $58,500.00–$75,000.00. This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO), 10 paid holidays annually, and paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount.