Job Description
PPD has an exciting opportunity for a [CRA] to join us and work exclusively for one of our strategic pharmaceutical partners in [the US] in our functional service partnership (FSP) model. As part of the PPD services to this partner, you will be dedicated to client-specific projects and sites, collaborating with the client’s teams under some of their systems and processes.
This is a great opportunity for CRAs at any level currently working within the life science sector for pharmaceutical companies, biotech companies or CROs who would enjoy the opportunity to work for one client. You should thrive in project teams and be focused on delivering exemplary levels of customer service. You will have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work. [You will perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.]
Role and Responsibilities:
Acts as primary site contact and site manager throughout all phases of a clinical research study,
taking overall responsibility of allocated sites.
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH‐GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in‐depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on‐site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased
Subjects’ right, safety and well‐being are protected
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close‐out visits and records clear, comprehensive and accurate visit & non‐visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start‐up, study maintenance and study close‐out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, CRA‐M/PLM and works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Performs co‐monitoring where appropriate.
Experience or ability to support and/or lead audit/inspection activities as needed.
Education and Experience:
Bachelor’s degree preferred with strong emphasis in science and/or biology
Min. 2 years of direct site monitoring experience in a bio/pharma/CRO
Preferred therapeutic area experience in Ulcerative Colitis, Inflammatory Bowel Disease, Crohn’s Disease
Ability to travel domestically (and/or internationally) per country requirements approximately 65%‐75% of working time. Expected travelling 2‐3 days/week.
Current driver’s license required.
Knowledge, Skills and Abilities:
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Developing skills in Site Management including management of site performance and patient recruitment.
Developing level of monitoring skill and independent professional judgment.
Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Supports and/or leads audit/inspection activities as needed.
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
Works with high quality and compliance mindset.
Capable of managing complex issues, working solution-oriented.
Performs root cause analysis and implements preventative and corrective action.
Compensation and Benefits
The salary range estimated for this position based in North Carolina is $115,000.00-$145,000.00.
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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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 our 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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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