Sr. Clinical Research Associate or CRA II - Rockville, MD | Biospace
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Sr. Clinical Research Associate or CRA II

MacroGenics, Inc.

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Location:
Rockville, MD
Posted Date:
7/14/2017
Position Type:
Full time
Job Code:
17-915
Salary:
$60,000-$110,000
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary of Position

**Relocation assistance available**

The Sr. Clinical Research Associate will act as a key agent for the operational set-up, delivery and close out of clinical trials including assisting with monitoring, day to day management of vendor interaction, and the development of study documents and plans.  She/he will participate in the planning, implementation and general oversight of clinical trial activities in conjunction with the project leader.  Will oversee CROs, contract monitors and bioanalytical labs, manage study activities from start-up through close-out, help to identify, evaluate, and select investigative sites, and track and review patient status including recruitment.

Responsibilities and Job Duties
* Clinical Trial Planning - Provides operational and strategic input prior to commencement of clinical trials that include, but are not limited to: clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) site selection and budget planning.

* Monitoring Activities - Manages clinical monitoring activities and the overall site activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics.  Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs Clinical Project Manager and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation.  May participate in site visits as needed or accompany junior team members for training purposes

* Site Management - Communicates with clinical trial sites regarding all logistics including contract agreements, support materials and training and assists in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations. Coordinates set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance.  Develops and coordinates study training for study team, investigational sites, and vendors.   Manages clinical site budgets, investigator payment processes and handles invoices related to projects assigned. Escalates study and team issues to project leader.

* Vendor Oversight - May participate in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel.  May Serve as the primary project contact for communication and coordination for the third-party vendors.  Reviews monitoring trip reports and tracks resolution of all action items related to CROs.  Insures that vendors comply with all required standards and raises any issues and/or concerns.  Assists with contract and budget preparation, negotiations and management throughout the trial life cycle

* Internal/External Meetings - Organizes and manages internal team meetings, investigator meetings, and other trial- specific meetings as required.   Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents.

* Data Listing Review - Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.  Proactively identifies any potential risks and recommends and implements actions to avoid or mitigate problems while considering the appropriate trade-offs of balancing risks with study deliverables and costs.

* Trial Master File -  Ensures study regulatory files are collected and inventoried and filed as per MacroGenics requirements

* Ancillary Supplies – Ensures study materials and supplies are available in a timely manner at the location here needed.

* Study Management Tools - Responsible for the maintenance and updating of data as appropriate in project management tools including CTMS. Implements and maintains project processes and tracking systems (i.e. Screening and Randomization status) and reports to management

Requirements

Education
BA/BS or equivalent degree in a scientific discipline or related healthcare field

Experience - Sr. CRA
At least 5 years of clinical trial experience in a pharmaceutical, biotechnology company or clinical research organization(CRO)
Prior experience performing the responsibilities mentioned above
Significant clinical operations experience with evidence of increasing responsibility within the biotech or pharmaceutical or CRO industry
Experience managing Phase 1, 2, 3 clinical trials

Experience - CRA II
At least two years of clinical trial experience in a pharmaceutical or biotech company or a clinical research organization (CRO)
Prior experience performing the responsibilities listed above
Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines

Knowledge, Skills and Abilities
* Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
* Ability to work on complex or multiple projects with minimal supervision
* Possesses critical thinking skills for problem solving
* Experience conducting multi-national / global clinical trials
* Needs lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
* Solid attention to detail and excellent organization skills
* Solid interpersonal skills and communication skills (both written and oral)
* Ability to establish priorities, excellent sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
* Demonstrates problem solving skills
* Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
* Strong working knowledge of clinical trial conduct, EDC systems and IVRS            

Preferred Qualifications
Experience in oncology preferred