Senior Clinical Research Associate
Worldwide Clinical Trials - Colorado

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Summary: Responsible for site feasibility, site selection and qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance to Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). 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.

Responsibilities:
Tasks may include but are not limited to:
Perform feasibility studies (pre-study site selection) when required

Conduct all level of monitoring visits in accordance to GCPs and applicable local and international regulations and SOPs. This encompasses clinical trial material (CTM) accountability, regulatory document review and submission (as appropriate), clear and complete trip report writing and site management

Function as Lead CRA for global studies, coordinating CRAs, reviewing monitoring reports (if requested)

Provide mentoring and coaching to colleagues and site staff when needed

Manage/advise teams in therapeutic areas of proficiency as required or appropriate

Design monitoring tools as requested

Provide support for the design of CRFs and protocols as requested

Develop monitoring plans when required

Actively participate in study team meetings

Actively participate in investigator meetings

Conduct training for colleagues or study team as requested

Manage a cost centre and implement appropriate actions to keep within budget (UK and ROW)

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Skills:
Excellent oral and written communication skills

Excellent planning and organizational skills with effective time management

Excellent interpersonal skills

Ability to work logically and methodically

Ability to lead and motivate assigned team (if applicable)

Ability to chair meetings and participate in bid defenses

Initiative and problem solving skills

Ability to input into process initiatives, SOPs related to monitoring and site management activities

Knowledge:
Good understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements

In depth understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate

Thorough understanding of standard operating procedures

Proficient knowledge of Microsoft Office, eCRF, IVRS packages

Thorough understanding of clinical research principles and process

Requirements:
Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and with a minimum experience of three years as a Clinical Research Associate, OR

A minimum four-year college curriculum with a major concentration in biological, physical or health studies and a minimum experience of four years as a Clinical Research Associate, OR

Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Clinical Research Associate

Travel required

Valid current passport required

Driving license required

Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

Required Skills

Required Experience

Worldwide Clinical Trials - 18 months ago - save job - block
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About Worldwide Clinical Trials Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...