Assistant CRA (ACRA) - Northeast & Southeast US

About the role

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 5 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. You may be assigned limited site contact activities 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.

Responsibilities

• Completes study and site management activities as defined in the task matrix and as directed for the assigned study.
• Completes and documents study-specific training; orients and trains on study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers.
• Supports customization of Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklists and supports collection, as applicable.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient-facing materials and translations, as directed.
• Supports site staff with vendor-related qualification processes.
• Ensures system access is requested, granted, and revoked for relevant site staff during pre-activation and throughout the study.
• Provides support for site staff training follow-up, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and throughout the study.
• Supports Essential Document collection, review, and updating in systems.
• Follows up on missing study vendor data such as ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports site payment processes by coordinating with various functional departments and sites.
• Supports system updates and reconciliations; follows up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports.
• Verifies document collection status in company systems and drives action for missing, incomplete, or expired documents.
• May 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.
• Maintains and completes 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.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). 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 and the 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 in-depth investigation for root cause analysis and problem-solving.
• Proficient computer skills with good knowledge of MS Office; ability to learn and use appropriate software.
• Ability to 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 the Assistant CRA 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.

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, 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 eligible colleagues the opportunity to purchase company stock at a discount.