Assistant CRA - (Home or Office based) - United Kingdom
On-Site or Remote
About the Role
Contact firstname.lastname@example.org for direct referral this role
We are seeking the brightest stars to take part in an intensive, in-house training programme in which you can fast track your career as a Clinical Research Associate!
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
As an Assistant CRA (ACRA), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions, and deliver results.
Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to 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. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.
- Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
- Completes and documents study-specific training
- Orients and trains on any company/study-specific systems
- Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project
- Supports to customize 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 review translations, as directed
- Supports site staff with the vendor related qualification process, where applicable
- Provides support by ensuring 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
- Support with 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
- Follow 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 RCRA and as per Task Matrix
- May perform a specific role profile for FSP opportunities according to Client requests
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience:
Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 1 - 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- 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 and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Strong attention to detail
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to: 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
About the Company
PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our 4i Values:Integrity – Innovation – Intensity – InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group
How to Apply
If you would like a direct referral, please contact the Black Pharma Team at email@example.com