We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.

What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.

We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.

ABOUT THE JOB

The Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.

ABOUT THE JOB
The Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.

Our salary ranges are determined by various factors. The actual base compensation for this position may vary depending on experience, market conditions, education/training, skill level, and location.

HERE IS WHAT YOU WILL DO:

Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study

Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements

Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies

Create annotated visit report templates and other documents and strategies related to site management and monitoring

Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented

Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements

Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control

Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team

Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed

HERE IS WHAT YOU BRING TO THE TABLE:

RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training

Previous CRA experience preferred

Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy

Solutions-oriented approach to problem solving

Familiarity with medical and pharmaceutical industry, and related terminology and practices

Extensive knowledge of Food and Drug Administration regulations and their practical implementation

Willingness to travel and perform remote and on-site monitoring, if needed

Proficiency in Microsoft Word, Excel, and PowerPoint

Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.

Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [email protected].

ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.