inVentiv Health Clinical Research Associate (Malaysia) in Petaling Jaya, Malaysia
InVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With over 7000 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
DYNAMIC ENVIRONMENT. REWARDING CAREER.
Although inVentiv Health Clinical is one of the world’s leading providers of contract drug development services, we recognize you have a choice of where you seek employment. Here’s why inVentiv Health Clinical should be at the top of your list.
You will join a team of individuals who have the desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. Continuing professional development, personal incentive awards, competitive benefits, and opportunities can all be part of your career growth. Our culture is focused on internal communications and mutual respect for each other and our clients, and an absolute commitment to quality in everything we do.
We have great openings and opportunities across the South East Asia Region including; Singapore, Malaysia, Taiwan, Thailand and Hong Kong.
Title Clinical Research Associate (Malaysia)
Job ID 13761
Priority 1 - High
Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and The Client Standard Operating Procedures (SOPs) and business processes.
Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Ensure safety and protection of study subjects according to the monitoring plan, The Client SOPs, ICH Guidelines, and federal regulations.
Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Appropriately escalate serious or outstanding issues to senior level CRA/Clinical Operations Manager (COM) or the appropriate project team member(s).
Facilitate Quality Assurance Audit processes as indicated.
Ensure regulatory inspection readiness at assigned clinical sites.
Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
Support identification of new qualified clinical sites and conduct site feasibility assessments.
Prepare and submit country specific clinical study initial and amendment submission packages to ethics committees (EC) and competent authorities (CA) as applicable. Follow up with EC/CA regarding approvals as necessary.
Ensure negotiation and execution of Clinical Study Agreements which include financial agreement.
Ensure investigator grant payments are received by investigators.
Ensure local reporting to EC/CA or appropriate group occurs.
Document and supplies handling activities to include:
Support study documentation translation to and from English.
Study documentation customization by country and/or site requirements.
Document retention per country specific requirements.
Distribution of study documents and supplier to clinical sites as needed.
Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator, pharmacist), peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with The Client personnel.
Identify, evaluate and recommend new/potential investigators/sites on an on-going basis. Potential sites may be identified through networking or internal The Client requests to assist in the placement of planned clinical studies with qualified investigators.
Participate in departmental meetings.
Employ good fiscal management to conserve costs of departmental operation and controls travel expenses, with guidance from senior level CRA/COM.
Identify and partner with other The Client personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of The Client ICFO and conserve overall departmental operating costs.
Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
Bachelor’s Degree required; medical/science/nursing background is preferred
MS, MA, MBA, MPH desired
Minimum of 1 year of clinically-related experience, of which 6 months must be in clinical research monitoring
Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
Experience in on-site monitoring of investigational drug or device trials is required
City Petaling Jaya
Country Malaysia [MY]