Assistant CRA (ACRA) - Northeast & Southeast US

About the role

Join a global team that has supported the top 50 pharmaceutical companies and more than 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. You’ll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for 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/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 task matrix, as applicable and directed for study assigned.
• Completes and documents study-specific training; orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports customization of Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• 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 the vendor-related qualification process, where applicable.
• Ensures system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, 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 subsequent course of the study.
• Supports Essential Document collection, review, and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site.
• Supports system updates and reconciliations, as directed, and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by CRA and as per 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 will 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 proven ability to handle multiple tasks efficiently and effectively.
• Proven flexibility and adaptability.
• Ability to work in a team or independently, as required.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate 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 all study documents, electronic study data systems, CTMS, and dashboards.
• Excellent English language and grammar skills.

Environmental Conditions

• Work is performed most of the time in an office or home office environment; occasional travel to clinics/hospitals may be required.
• Exposure to electrical office equipment.
• The Assistant CRA role does not involve regular travel; however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).

Pay

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

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours 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) offers eligible colleagues the opportunity to purchase company stock at a discount.